December 31, 2002
J&J's
Secret Weapon -- Why is this biotech secret?
An interesting article about Minnesota-based SurModics, the company that makes
the coating technology being used for Johnson & Johnson's coated stents.
(source: The Motley Fool)
December 17, 2002
Women,
Men Benefit Equally from Angioplasty
Women with heart disease who undergo angioplasty fare as well as their male
counterparts when it comes to survival after the procedure, researchers report.
(source: Suzanne Rostler, Reuters Health)
December
17, 2002
Court
Denies Cook Motion in Paclitaxel-Eluting Stent
Dispute with Boston Scientific
According to this Boston Scientific press release, the courts have denied a
motion by Cook related to the October injunction regarding the Cook/Guidant
agreements -- a decision impacting the race to market coated or drug-eluting
stents in the United States. A somewhat different view of the same
court decision is offered in Cook's
press release.
(source: Boston Scientific Corporation / Cook Inc.)
December 17, 2002
Guidant
Completes Enrollment in Clinical Trial to Study
Carotid Artery Stenting as Alternative Treatment
for High Surgical-Risk Patients
Called ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk Patients),
the trial is a prospective, non-randomized, multi-center, single-arm study
that treated 513 patients at 41 sites in North and South America. Patients
were implanted with Guidant's investigational ACCULINK Carotid Stent
System, designed specifically for the treatment of atherosclerotic lesions
in the internal carotid artery. During the latter phase of the trial, 303 patients
were treated with the ACCULINK Stent System in combination with the investigational
ACCUNET Embolic Protection System, which is designed to trap particles
of atherosclerotic plaque during the endovascular stenting procedure.
(source: Guidant Corporation)
December 15, 2002
THE
YEAR IN IDEAS; The Fail-Safe Heart Procedure
One of the "ideas" in this year-end NY Times Magazine Feature "The
Year in Ideas" was the coated stent.
(source: Sandeep Jauhar, New York Times (free NYT registration required))
December 7, 2002
Accounting
Board's Webster Undergoes Heart Treatment
William H. Webster, recently in the news after much controversy resulting in
his resignation from the newly created SEC accounting oversight board, said
he underwent a coronary angioplasty yesterday after experiencing shortness
of breath Thursday night during a tennis game.
(source: Washington Post)
December 5, 2002
Boston
Scientific Signs Definitive Agreement to Acquire
Inflow Dynamics Inc.
A press release from the company about their acquisition of a German company
that recently presented results of their "Moonlight" trial, showing
that their proprietary passive stent coating, Iridium
Oxide, brought in-stent restensosis rates to under 12%.
(source: Boston Scientific Corporation)
December
4, 2002
Bypass
Surgery Favored Over Stents for Some Patients
in Long-Term Comparison
The latest "angioplasty vs. surgery" study, this one a Dutch/Italian
study of 102 patients in today's Journal of the American College of Cardiology, shows
that "keyhole"-type bypass surgery in a single high-grade lesion
of the Left Anterior Descending (LAD) coronary artery may produce more durable
long-term results than angioplasty using a stent.. The study does not include
data from the newer "coated" stents which, in early results, have
shown great reduction in repeat procedures, but it does show that surgery may
warrant consideration in patients often recommended for angioplasty.
(source: Journal of the American College of Cardiology)
December 4, 2002
A "Cool" New
Addition to Heart Attack Treatment
Another type of interventional device is now being tested -- one that cools
the body from the inside-out. A new study demonstrates a practical method for
quickly lowering body temperature during angioplasty. Researchers plan to test
its potential to reduce heart attack damage. You can read
a PDF of the actual study here. You can also find more information
about The SetPoint® System used in this study at Radiant
Medical's website.
(source: Journal of the American College of Cardiology / Radiant Medical
Inc.)
December
3, 2002
Playing
Ambulance Roulette
A dramatic article about the use of emergency angioplasty, rather than thombolytic
therapy, to treat heart attacks -- "Death rates after 30 days are lower
by almost 50 percent. Also, angioplasty results in an open coronary artery
90 percent of the time, compared with 54 percent for thrombolytic drugs." (The
New York Times requires readers to register, but it's free.)
(source: Sandeep Jauhar, MD and Norma Keller, MD, New York Times)
December 3, 2002
Boston
Scientific Announces Acquisition of Smart Therapeutics,
Inc.
What started as cardiovascular devices are now used throughout the body --
neurovascular in this case -- Smart is the maker of the Neuroform Microdelivery
Stent, an ultra-thin, self-expanding nitinol stent, which is delivered through
a micro-catheter and is specially designed to bridge the opening of "wide neck" aneurysms.
(source: Boston Scientific Corporation)
December 2, 2002
Boston
Scientific Announces Launch of New Balloon Catheters
A company press release announcing the launch of two new balloon catheters
in the United States, the Maverick2 Monorail Coronary Balloon Dilatation
Catheter and the Quantum Maverick® Coronary Balloon Dilatation Catheter.
Both have previously been available internationally and have now been approved
by the US FDA.
(source: Boston Scientific Corporation)
November
27, 2002
Guidant Comments on Cook-Boston Scientific Litigation
Court of Appeals Denies Stay of Injunction;
Cook to Move Forward with Appeal
(source: Guidant Corporation)
November 27, 2002
Appeals
Court Denies Cook's and Guidant's Requests For
Stay of Injunction In Paclitaxel-Coated Stent
Dispute With Boston Scientific
The latest development in the "stent wars" as announced in a company
press release. Also read
an article about this subject from Dow Jones.
(source: Boston Scientific Corporation / Dow Jones News)
November 22, 2002
Statistics
Show 94 Percent Success Rate for HTA® System
At three years, this alternative to hysterectomy has shown to be 94% effective
-- this device is another demonstration of the wide-ranging revolution in healthcare
that has occurred as a result of interventional medicine.
(source: Boston Scientific Corporation)
November 20, 2002
Tiny
Filters reduce risk from procedure to clean up
neck arteries
A new study, using Cordis' AngioGuard, suggests that with the use of embolic
protection devices (filters) the interventional approach to carotid artery
disease may be better than the current "gold standard" of open surgery:
carotid endarerectomy. You can read
another account of this study from Reuters. The
New York Times also has an article about this study (they require registration
which is free).
(source: Daniel Q. Haney, AP Medical Editor / Michael Conlon, Reuters
/ Lawrence K. Altman, New York Times)
November 19, 2002
Boston
Scientific Announces Preliminary Fire Trial Results
The company today announced preliminary results from its FIRE clinical trial
which studied the Company's FilterWire EX™ Embolic Protection Device. The cumulative
incidence of MACE at 30 days was 9.5 percent for patients in the FilterWire
EX device arm compared with 11 percent for patients in the arm incorporating
the GuardWire Plus device.
(source: Boston Scientific Corporation)
November 18, 2002
Study
Backs Longer Post-Angioplasty Therapy; Blood
Thinner May Cut Death Risk
Patients who have undergone angioplasty or similar artery-opening procedures
cut their risk of death by taking aspirin and a clot-reducing drug (clopidogrel
a.k.a. Plavix) for 12 months afterward instead of the currently recommended
four weeks, researchers said on Monday. Read
another article on this study from Associated Press.
(source: Reuters / Lindsey Tanner, Associated Press)
November 18, 2002
Bone
marrow cell transplant treats clogged leg arteries
Bone marrow cells implanted into blood-starved (ischemic) legs formed new blood
vessels, increased blood flow and prevented amputation in people with peripheral
artery disease, researchers reported today at the American Heart Associations
Scientific Sessions 2002. "This is the first multicenter and double-blind
clinical study to prove the clinical efficacy of growing new blood vessels
(angiogenesis) using bone marrow cell transplantation," says the study's
lead author Hiroya Masaki M.D., Ph.D.
(source: American Heart Association)
November 18, 2002
Boston
Scientific Announces 30-Day Safety Data for the
Complete Study Population of TAXUS IV Drug-Eluting
Stent Clinical Trial
The results supported safety, as demonstrated by overall 30-day MACE (Major
Adverse Cardiac Events) rates of only 3.0 percent. Stent thrombosis rates -
another early indicator of safety - were less than 0.5 percent. "This
is the largest TAXUS study to date, and it reinforces the findings of earlier
studies and offers additional preliminary evidence that polymer- based, paclitaxel-eluting
stents appear to be a safe treatment for coronary artery disease," said
Dr. Stephen Ellis, the trial's Co-Principal Investigator. Read
another article on this subject from Reuters.
(source: Boston Scientific Corporation / Reuters)
November
17, 2002
Death
rates lower in hospitals that follow heart attack
guidelines
Heart attack patients at hospitals that lag behind in following treatment guidelines
had a one-third greater risk of dying before discharge than patients at "leading" hospitals,
according to a study reported today at the American Heart Associations
Scientific Sessions 2002. Death rates ranged from 17.6 percent at "lagging" hospitals
(those with low guideline adherence) to 11.9 percent among "leading" hospitals
(those with the highest overall guideline adherence).
(source: American Heart Association)
November 17, 2002
Muscle
cell transplants repair damaged heart tissue
Researchers safely transplanted 16 patients' skeletal muscle cells into their
own severely damaged hearts in the first human testing in the United States,
according to a study reported today at the American Heart Associations
Scientific Sessions 2002. "We have been able to regenerate dead heart
muscle, or scar tissue, in the area of heart attack without increasing risk
of death," says lead author Nabil Dib, M.D., director of cardiovascular
research at the Arizona Heart Institute in Phoenix."
(source: American Heart Association)
November
17, 2002
Emergency
angioplasty OK without surgical back-up
Survival rates following emergency angioplasty for heart attack are the same
regardless of the availability of on-site cardiac surgery, according to research
reported today at the American Heart Association's Scientific Sessions 2002. "This
is the largest study to date demonstrating the benefit of immediate angioplasty
in acute heart attack patients," says lead researcher Timothy A. Sanborn,
M.D., chief of the division of cardiology at Evanston Northwestern Healthcare,
in Evanston, Ill. You can also read
another article on this subject from HealthScout. For more in depth
information on the use of emergency angioplasty, read our "Hot
Topic" on the subject.
(source: American Heart Association / HealthScout)
November 17, 2002
Engineered
blood vessels prove durable and clot resistant
Science fiction becoming fact -- in a study reported today at the American
Heart Associations Scientific Sessions 2002, researchers have built mechanically
sound blood vessels out of tissue from human skin cells. The technique involves
tissue engineering, an emerging science that takes cells from the body, manipulates
them in the laboratory to create functional tissue, and puts the new tissue
back into the patient. The result could be new blood vessels for use in heart
bypass operations -- vessels that would be built from a person's own cells
and therefore not rejected by the body's immune system.
(source: American Heart Association)
November 15, 2002
Guidant
gets permission to show FDA its stent data
The company said on Friday that a U.S. judge has ruled that the medical device
maker has permission to submit to U.S. regulators data about a key new heart
disease treatment that has been entangled in a licensing dispute with rival
Boston Scientific Corp.
(source: Susan Nadeau, Reuters)
November 14, 2002
Additional
Results From TAXUS Drug-Eluting Stent Clinical
Trials to be Presented at AHA
Thirty-day safety data for the complete study population of the TAXUS IV trial
will be presented, as will 12-month clinical follow-up data from the TAXUS
I trial. Both presentations will be made on November 18, and the results will
be announced in a news release issued by the Company that day.
(source: Boston Scientific Corporation)
November 13,
2002
New
Test For Risk Of Heart Disease: Study Shifts
Focus From Cholesterol to C-Reactive Protein
(CRP)
The current issue of the New England Journal of Medicine (read
the abstract.) discusses how a test for C-reactive protein (CRP) appears
to be as good as, if not better than, the standard cholesterol tests now given
for estimating a person's risk of having a heart attack or stroke."Elevated
concentrations of CRP appear to identify individuals at increased risk of cardiovascular
disease even when their cholesterol levels are normal." You can also read
a statement from the American Heart Association about the CRP test.
(source: David Brown, Washington Post / New England Journal of Medicine
/ American Heart Association)
November
8, 2002
Patients
Seek Internet Rx
People are twice as likely to go online for information about medical procedures
than ask their doctors, survey says.
(source: HealthScout)
November 8, 2002
The
Overachievers: Boston Scientific Has Heart
A story for those interested in the business of medicine: the turnaround and
growth at Boston Scientific. Also discusses the current status of the drug-eluting
stent field (see our "Hot
Topic" on the subject)
(source: Matthew Herper, Forbes.com)
November 5, 2002
OL
McKinney undergoes angioplasty
Dallas Cowboys offensive lineman Jeremy McKinney has undergone a heart procedure
to correct a narrowing of an artery.
(source: Dallas Cowboys Team News)
November 4, 2002
Desperate
company finds huge opportunity with tiny syringe
A story about EndoBionics development of a "microneedle" and a novel
way to deliver drugs to the coronary arteries. The company recently signed
an agreement with Medtronic (read
press release). This article chronicles how the company started and
survived. There is also a graphic of
the technology involved.
(source: Tom Abate, San Francisco Chronicle)
October 24, 2002
Guidant
Submits Application for FDA Approval of MULTI-LINK
VISION Cobalt Chromium Coronary Stent
Guidant has submitted its application for pre-market approval for its newest
addition to the MULTI-LINK line: the VISION Coronary Stent System. The new
stent is constructed of a cobalt chromium alloy, enabling the stent to have
thinner stent struts and enhanced deliverability while maintaining excellent
radial strength and visibility.
(source: Guidant Corporation)
October
24, 2002
Brain
Aneurysm Trial Halted After Less-Invasive Treatment
Is Proved Superior To Invasive Surgery
Results released today, and published in The Lancet, from the International
Subarachnoid Aneurysm Trial (ISAT) demonstrate that less-invasive endovascular
treatment with detachable platinum coils produces better outcomes for patients
suffering from ruptured brain aneurysms than neurosurgical clipping -- another
example of how the interventional techniques pioneered in the field of angioplasty
are being applied successfully throughout the anatomy. You can read
the abstract from The Lancet here. You may also wish to read
a New York Times article about the procedure, titled "Fixing Aneurysms
Without Surgery", dated November 12, 2002. Both of these sources are free,
but require registration.
(source: Boston Scientific Corporation / The Lancet / New York Times)
October 22, 2002
Calcium-blocker
drug slows artery clogging better than beta blocker
This European study tested two high blood pressure medications: lacidipine,
a calcium channel blocker, and atenolol, a beta blocker. (Lacidipine is not
currently approved for use in the U.S.)
(source: American Heart Association)
October
22, 2002
FDA
advisors back approval of drug-coated stent
A U.S. advisory panel on Tuesday unanimously backed Johnson & Johnson's
CYPHER drug-coated stent, a new, eagerly-awaited technology to treat
clogged coronary arteries and keep them from becoming blocked again. Forbes
calls this "A
Big Win for Johnson & Johnson". Also read the company's
press release. The recommendation, however, included several requirements
that might slightly delay final FDA approval, as
noted in this article from TheStreet.com.
(source: Reuters / Cordis Corporation / Forbes)
October 22, 2002
Boston
Scientific Tripled U.S. Market Share With New
Express Stent
Boston Scientific Corp. tripled its share of the U.S. stent market in the last
two weeks of the third quarter after the introduction of its Express2 stent,
going from "roughly 6% of the U.S. stent market as of mid-September to
18% of the market by the end of the month."
(source: Daniel Rosenberg, Dow Jones Business News)
October 16, 2002
Cost
and Cost-effectiveness of an Early Invasive vs
Conservative Strategy for the Treatment of Unstable
Angina and NonST-Segment Elevation Myocardial
Infarction
In certain type of heart attack patients, the clinical benefit of an early
invasive strategy (i.e. angioplasty or other percutaneous coronary intervention)
was achieved with a small increase in cost, yielding favorable projected estimates
of cost per year of life gained. These results support the broader use of an
early invasive strategy in these patients. Also read
an article about this report from HealthScout News.
(source: Journal of the American Medical Association / Kathleen
Doheny, HealthScoutNews)
October
15, 2002
Angioplasty
safer, need for emergency surgery afterward plunges
From 1992 to 2000 the need for emergency bypass surgery after angioplasty has
dropped more than ten-fold. The rate in 1992 for emergency surgery was 1.5%
-- it is now 0.14%. The increased safety of angioplasty can be attributed to
increased physician experience, improved techniques, drugs which help prevent
clotting and the use of stents to keep arteries open. You can also read another
article on this from HealthScoutNews.
(source: American Heart Association / HealthScoutNews)
October 14, 2002
MRI
Predicts Heart Attack Risk; Imaging Test Creating
'Revolution' in Heart Care
IA study published in tomorrow's Circulation, discusses the use of 3-D
MRI imaging in the diagnosis of heart disease. This study is the first
to determine that MRI is a strong prognostic forecaster, says lead author
W. Gregory Hundley, a cardiologist and associate professor of internal medicine
and radiology at the Wake Forest University School of Medicine in Winston-Salem,
N.C. Such information is important because it helps us identify which
patients should receive more aggressive treatment. Read
another article about the study from the American Heart Association.
(source: Adam Marcus, HealthScoutNews / American Heart Association)
October 9, 2002
House
Passes Bill on Medical Technology
Article from the New York Times (registration required) about The U.S. House
of Representatives passing a bill "to speed the approval and marketing
of a new generation of medical technology that promises better diagnosis and
treatment of many illnesses. In return, the industry manufacturers of
medical devices will, for the first time, pay user fees so the government
can hire more people to review the inventions."
(source: Robert Pear, New York Times)
October
7, 2002
Court
Refuses to Stay Permanent Injunction in Paclitaxel-Coated
Stent Dispute Between Boston Scientific and Cook
Boston Scientific today announced that this morning the U.S. District Court
for the Northern District of Illinois denied Cook, Inc.'s request for a stay
of the permanent injunction issued last week in the dispute between Boston
Scientific and Cook over Cook's agreements with Guidant Corporation relating
to the development and distribution of paclitaxel-coated stents. Calling the
Cook-Guidant agreements a "subterfuge," the Court ruled that the
permanent injunction remains in place.
(source: Boston Scientific Corporation)
October 7, 2002
Medtronic's
Advanced Stent Delivery System with Breakthrough
Zipper Technology Receives FDA Approval
The company's press release states that "this new generation multi-exchange
delivery platform offers the unique advantages of precision, control and easy
exchange of guidewires and catheters.... The Zipper Delivery Platform was previewed
to cardiologists attending the recent Transcatheter Cardiovascular Therapeutics
(TCT) conference in Washington, DC, where three highly successful live cases
and the response from some of the worlds most eminent interventional
cardiologists demonstrated the groundbreaking nature of this exciting new technology."
(source: Medtronic Inc.)
October 7, 2002
How
to Fix the Edge Effect of Catheter-Based Radiation
Therapy in Stented Arteries
Edge stenosis remains a serious limitation of catheter-based vascular brachytherapy
(VBT). This study aims to identify the mechanisms and evaluate strategies to
minimize edge restenosis in patients treated with VBT.
(source: Circulation)
October 3, 2002
Guidant
Receives Humanitarian Device Exemption for New
Intracranial Stent
The company has received U.S. Food and Drug Administration (FDA) approval under
a Humanitarian Device Exemption (HDE) for its NEUROLINK® System designed
to treat atherosclerosis of the intracranial arteries, the vessels that distribute
blood through the brain. Under the HDE approval, patients with recurrent stroke
due to intracranial atherosclerosis who have failed medical therapy may be
treated with the NEUROLINK System.
(source: Guidant Corporation)
October 3, 2002
For
Heart Problem, Nowhere to Hide
The article starts "New imaging techniques are allowing cardiologists
to detect dangerous blood vessel blockages that are the cause of most heart
attacks," and continues with an overview of optical coherence tomography
(OCT) and several other new imaging techniques, such as intravascular ultrasound
(IVUS) and thermal imaging.
(source: Melinda T. Willis, ABCNews.com)
October 2, 2002
Cook
Incorporated To Appeal Latest Court Ruling
Cook Incorporated announced today it will ask for an immediate stay of a ruling
yesterday by the U.S. District Court for the Northern District of Illinois.
The company also said it plans to appeal an earlier ruling in that court blocking
Cook's right to manufacture and sell its ACHIEVE Drug Eluting Stent System
through a 2001 distribution agreement signed with Guidant Corporation. "Although
yesterday's ruling came as a disappointment to Cook, we believe our appeals
of the court's ruling, as well as of the injunction, will be upheld," said
Kem Hawkins, President, Cook Incorporated.
(source: Cook Incorporated)
October 2, 2002
The
End of the Line for Guidant Boston
Scientific Wins Again
Two interpretations of the implications of today's court decision can be read
in these companion articles from Forbes.com
(source: Katrina Keller and Forbes Staff, Forbes.com)
October 2, 2002
Guidant
Comments on Cook-Boston Scientific Litigation
Guidant Corporation reported that the United States District Court for the
Northern District of Illinois yesterday issued an injunction prohibiting any
performance under the agreements between Cook Incorporated and Guidant relating
to the development and distribution of paclitaxel eluting stents. The injunction
also prevents the use of information, data or technology generated or gathered
in connection with the agreements. "Guidant continues to be committed
to advancing this important lifesaving therapy and will pursue alternative
pathways to bring drug eluting stent technology to market," said Ronald
W. Dollens, president and CEO, Guidant Corporation. "Cook plans to immediately
seek a stay of the injunction and appeal the judge's ruling. We will also continue
to aggressively pursue the Guidant vs. Boston Scientific litigation."
(source: Guidant Corporation)
October 2, 2002
Angiotech
-- Court Issues Ruling On Data Injunction in
Boston Scientific-Cook Dispute
Angiotech comments on the court ruling. Angiotech is the producer of the paclitaxel
drug used in both the Boston Scientific and Cook stents drug-eluting stents. "TAXUS
I, II, III, ELUTES and ASPECT paclitaxel-eluting stent clinical trials have
produced consistent, reproducible, outstanding patient efficacy across an array
of stent platforms," said William L. Hunter, MD, MSc, Chairman and CEO
of Angiotech. "Angiotech partnered with Cook and Boston Scientific because
we were confident in their ability to deliver a superior product to cardiologists
and interventional radiologists worldwide. We are as comfortable with that
decision today as we were in 1997."
(source: Angiotech Pharmaceuticals, Inc.)
October
1, 2002
Court
Grants Boston Scientific Request For Injunction
In Paclitaxel-Coated Stent Dispute With Cook
The Court also enjoined sales under Cook-Guidant distribution agreement and
prohibits use of Guidant clinical data. This ruling represents the latest chapter
in the ongoing "stent wars", the race to gain approval and market
drug-eluting stents, new devices that have shown significant benefits in preventing
restenosis, or reblocking, of coronary arteries, and have been hailed as "revolutionary".
(source: Boston Scientific Corporation)
October 1, 2002
Pill
may prevent stent complication that re-blocks
arteries
Most hope for the prevention of renstenosis in stents and other coronary interventions
has been around the drug-eluting stent (see our "Hot
Topic"). But this study of 6 New Zealand rabbits found that a
drug similar to those used on the coated stents may be as or more effective.
Whether this small animal study translates to a viable treatment in humans
is yet to be seen; earlier attempts at solving the restenosis problem used
various oral medications and were not successful.
(source: American Heart Association)
October 1, 2002
"Slice" scanner
latest advance in early detection of heart disease
Interventional cardiology has advanced hand-in-hand with advances in imaging.
This latest study from Erasmus Medical Center in Rotterdam, the Netherlands,
demonstrates that an advanced imaging technique multislice spiral computed
tomography (MSCT) is a reliable, noninvasive way to detect blockages
in the coronary arteries, and can provide an accurate, noninvasive alternative
to coronary angiography (catheterization).
(source: American Heart Association)
September 28, 2002
Boston
Scientific Announces 30-Day Safety Data from
its TAXUS IV Drug-Eluting Stent Clinical Trial
"This provides the first evidence in our program that diabetics benefit from
paclitaxel-eluting stents," said Jim Tobin, President and Chief Executive Officer
of Boston Scientific. "Despite the small sample, this data is very intriguing
and holds great hope for diabetic patients. Diabetic patients experience far
more restenosis following angioplasty and stenting, and they may stand to benefit
dramatically from these improvements."
(source: Boston Scientific Corporation)
September 27, 2002
Surgery
Beats Balloon for Heart Disease
Results of a study published in The Lancet, show that surgery patients
may be less likely to die or need repeat procedures. However, many cardiologists
point out that the data (patients were enrolled from 1996-1999) do not adequately
reflect the advances in interventional techniques and devices, namely stents,
since that time. An accompanying commentary by Drs. William W O'Neill and Cindy
L Grines, states that the gap between surgery and interventional techniques
continues to narrow, especially with the advent of drug-eluting,
or coated, stents.
(source: Kathleen Doheny, HealthScoutNews)
September 26, 2002
Clearing
the Path to a Healthier Heart: X-Sizer® device
prevents traveling blood clots
The device, called the X-SIZER Catheter System, breaks up blood clots and plaque
in diseased arteries. A miniature vacuum on the X-SIZER is then used to remove
the arterial debris to prevent it from traveling to other parts of the body.
This device could prevent thousands of major heart attacks each year in the
United States, says Dr. Gregg Stone, director of cardiovascular research at
Lenox Hill Hospital in New York City and lead investigator of the X-TRACT study.
More information on the device is available from the manufacturer EndiCOR
Medical, Inc.
(source: Robert Preidt, HealthScout News / Endicor Medical, Inc.)
September 25, 2002
New
Vascular Therapy Device Receives FDA Clearance;
CryoVasculars Device Gently Opens Blocked
Peripheral Arteries
The FDA has approved a new type of angioplasty balloon (the PolarCath Peripheral
Transluminal Angioplasty System) that uses nitrous oxide to cool the artery
as it is opened. The process is called Cryoplasty. Read more about the
technology from the company's
website.
(source: Cryovascular Systems)
Two Major Drug-Eluting
Stent Studies Show Very Low Restenosis Rates; "may
revolutionize treatment of heart disease"
September 26, 2002
Boston
Scientific Announces Final Results of its TAXUS
II Drug-Eluting Stent Clinical Trial
The company today announced final, six-month results of its TAXUS II paclitaxel-eluting
stent clinical trial. The study reports in-stent restenosis rate of 2.3 percent,
in-segment rate of 5.5 percent. It is the Company's first large drug-eluting
stent trial, and the results convincingly demonstrated both safety and efficacy
in reducing coronary restenosis. "These results are compelling evidence
of the safety and effectiveness of TAXUS paclitaxel-eluting stents for the
treatment of de novo coronary disease," said Professor Antonio Colombo,
M.D., the trial's Principal Investigator. "In addition to impressive reductions
in restenosis rates, we also saw a beneficial edge effect, as indicated by
greater lumen diameters and less late loss. The restenosis rates are already
so low at the edges that further differences are not seen in this sample size."
(source: Boston Scientific Corporation)
September 24, 2002
Final
Results of Large-Scale U.S. Study Confirm Positive
Performance of Cordis CYPHER Sirolimus-eluting
Stent
As reported at this year's Transcatheter Cardiovascular Therapeutics (TCT)
symposium, this study (SIRIUS) of 1,058 patients with eight-month angiographic
follow-up showed minimal in-stent late lumen loss (0.17 mm) in patients treated
with the CYPHER Stent. The 3.2% rate of angiographic in-stent restenosis
represents a 91% reduction vs. the control arm (bare metal stent), and the
8.9% angiographic in-lesion restenosis (including a 5-mm area at each end of
the stent) represents a 75% reduction vs. the control arm. Co-principal investigator
Dr. Jeffrey W. Moses stated, The remarkable results of the CYPHER Sirolimus-eluting
Stent are holding. Findings of the SIRIUS trial are very positive and consistent
with results of earlier studies. There are no significant differences between
our preliminary findings and our final data set. The results continue to support
the excellent performance of the product. Read
another article on the J&J/Cordis study from Reuters.
(source: Cordis Corporation)
September 24, 2002
Strong
statin therapy reverses plaque build-up in arteries
Previously it has been widely held that lowering LDL, a.k.a. "bad cholesterol",
helped to prevent progression of coronary artery disease. However, this study
in today's Circulation, shows that bringing LDL to lower than optimal
levels actually can reverse the build-up of artery-clogging plaque.
(source: American Heart Association)
September 24, 2002
Boston
Scientific Announces Victory Trial Results
A press release announcing results of the company's VICTORY clinical trial,
which studied the Express coronary stent system to evaluate safety and
efficacy of coronary artery stenting with the Express coronary stent system
in the treatment of de novo or restenotic lesions of native coronary arteries
and for abrupt closure and threatened abrupt closure (AC/TAC) indications.
(source: Boston Scientific Corporation)
September 23, 2002
Angiographic
Findings of the Multicenter Randomized Study
With the Sirolimus-Eluting Bx Velocity Balloon-Expandable
Stent (RAVEL)
Read this abstract about the RAVEL trial, conducted at the Thoraxcentre in
Rotterdam, subtitled "Sirolimus-Eluting Stents Inhibit Restenosis Irrespective
of the Vessel Size ".
(source: Circulation)
September 20, 2002
Boston
Scientific and Medtronic Announce Settlement
of Litigation
These two medical device companies have settled a number of patent infringement
lawsuits and have agreed to cross-license certain patents in the fields of
abdominal aortic aneurysm repair, embolic protection, nitinol technology and
catheter manufacture.
(source: Boston Scientific Corporation)
September 19, 2002
Boston
Scientific Announces Investment and Distribution
Agreements With Precision Vascular Systems
Precision Vascular has developed a proprietary line of guidewires and microcatheters
for accessing brain aneurysms, tumors and other blood vessel lesions of the
brain. Boston Scientific's Target division expects to begin distribution of
Precision Vascular's guidewires early in the fourth quarter of this year.
(source: Boston Scientific Corporation)
September 17, 2002
Angioplasty
at 25 - From a Homemade Balloon to 2 Million
Patients a Year; Created on Kitchen Table, Device
Is Now Leading Treatment for Heart Disease
Our press release celebrating the 25th anniversary of the first coronary angioplasty
performed in the cath lab by Dr. Andreas Gruentzig. (see
the video).
(source: Angioplasty.Org)
September
17, 2002
Gene
therapy promising for preventing restenosis
An experimental gene transfer technique shut down cell re-growth in the arteries interior
lining and reduced the inflammatory response two main causes of re-narrowing
of newly opened blood vessels, researchers report in todays rapid access
issue of Circulation: Journal of the American Heart Association.
(source: American Heart Association)
September 14, 2002
"Everything's
Fine" Cheney Says After Heart Exam
Vice President Cheney, who has history of heart problems, declared "everything's
fine" after a routine cardiovascular check at a Washington hospital yesterday.
Jonathan Reiner gave the 61-year-old vice president a clean bill of health,
reporting that his high-tech pacemaker "continues to function flawlessly
and has not detected nor treated any arrhythmia," according to Cheney's
spokeswoman Mary Matalin. Cheney had a stent placed in November 2000 and an
angioplasty In March 2001.
(source: Washington Post / CNN)
September 12, 2002
Boston
Scientific Announces FDA Approval for Express2 Coronary
Stent System
Express stent technology has potential for future use in a broad range of applications,
which may include peripheral vascular and neurovascular applications, in addition
to coronary applications. The Company also plans to use the Express2 stent
system as the platform for its TAXUS drug-eluting stent program.
(source: Boston Scientific Corporation)
September 12, 2002
Clot-Busting
Drugs Save Heart Attack Victims; Study finds
early therapy effective when time is important
A French study shows results that contradict
the recommended standard of care in the U.S.
-- that primary angioplasty is superior to clot-dissolving
drug. However, the results are not as clear-cut
as they could have been, due to low enrollment
and financing issues. In addition, 25 percent
of the patients who got clot-dissolving therapy
ended up undergoing "rescue angioplasty" when
it was suspected the initial treatment had failed.
(source: ed Edelson, HealthScoutNews)
September 3, 2002
Cook
Incorporated's ACHIEVE Paclitaxel-Eluting
Coronary Stent Receives First CE Mark Approval
For Sale In Europe
Cook Incorporated's ACHIEVE Drug Eluting Coronary Stent System, which
uses the clinically proven benefits of paclitaxel to reduce the rate at which
arteries reclog following angioplasty, has received CE Mark approval for sale
in
Europe. The system is the first paclitaxel-coated coronary stent approved for
sale in Europe.
(source: Cook Group, Inc.)
September 2, 2002
European
Society of Cardiology: Coronary Artery Disease
and Rhythm Disorders Hot Line and Clinical Trial
Update Session
This update brief, prepared by Dr. Christian
Leuner, University Hospital Bielefeld, Germany,
discusses seven clinical trials presented at
this year's ESC Congress: BEST, Euro-SPAH, PRAG
4, OPTIMAAL, ACE, TEN-HMS and ACTION
(source: European Society of Cardiology)
August
27, 2002
Vitamin
Cocktail After Angioplasty Boosts Heart Health
A cocktail of B vitamins may lower the risks of heart attack, repeat surgery
and death for patients who have undergone the artery-clearing heart surgery
angioplasty, researchers report. In the new study, patients who took folic
acid, vitamin B12 and vitamin B6 for 6 months fared better after one year,
compared with patients who did not take the vitamin combination.
(source: Ed Edelson, HealthScout)
August 21, 2002
'Key Hole' or Minimally Invasive Bypass, Stents Work for Heart Patients
Patients who have a specific type of blocked heart artery seem to do equally
well if they undergo artery-clearing angioplasty or a minimally invasive "key
hole" bypass surgery, researchers report in the New England Jounral of
Medicine. While the short-term results for the angioplasty group were better,
more repeat procedures were needed (29%) compared with the minimally invasive
bypass (8%). With the advent of coated-stents, it is expected that these figures
will be much closer. Read
the abstract in the the NEJM.
(source: Ed Edelson, HealthScoutNews / New England Journal of Medicine)
August 15, 2002
PharmaSonics
Announces Financing in Anticipation of Final
Intravascular Sonotherapy® Trial Results;
Pivotal U.S. and European Trial Results to Be
Presented in Fall of 2002
"The SWING trial results will be announced
around the same time as the clinical results
for drug coated stents," explained Ronald
Caputo, M.D., investigator for the SWING trial,
and an interventional cardiologist at St. Joseph's
Hospital, Syracuse, New York. "This is great
news for all of us in the field of interventional
cardiology. Assuming FDA approval, physicians
will have more clinical and economic choices
for treating patients with stent restenosis.
There are always going to be cases where you
will need to use more than one line of therapy
to treat restenosis, especially with difficult
lesions, multi-vessel disease and recurring in-stent
restenosis. Intravascular Sonotherapy and drug
coated stents should complement each other nicely
in our daily practice."
(source: PharmaSonics, Inc.)
August 14, 2002
Guidant's
MULTI-LINK Stents Demonstrate Benefit to Heart
Attack Patients
The clinical data from the CADILLAC trial demonstrates conclusively the
benefit of stent implantation as an immediate treatment for heart attack victims, concluded
principal investigator Gregg W. Stone, M.D., Cardiovascular Research Foundation,
Lenox Hill Heart and Vascular Institute, New York. For patients presenting
at centers skilled in angioplasty, stenting should now be considered the new
standard of care.
(source: Guidant Corporation)
August 8, 2002
Guidant's
Stent for Small Vessels Demonstrates Excellent
Clinical Outcomes at Six Months
These clinical results establish the MULTI-LINK PIXEL Stent as an effective
and minimally invasive option for treating small diameter vessels, which can
be more difficult to treat due to the distal location of the lesions and the
possibility that abrupt closure may occur, said David A. Cox, M.D., of
the Presbyterian Hospital in Charlotte, N.C., who served as principal investigator
of Guidants MULTI-LINK PIXEL registry. Small vessels are defined as those
with diameters of 2.5 mm or less; approximately 20 percent of atherosclerotic
lesions occur in such vessels.
(source: Guidant Corporation)
August 8, 2002
Medtronic
Announces First In Next Generation Of Guide Catheters
For Angioplasty
6-French Medtronic launcher guide catheter offers patients and interventional
cardiologists a pathway for performing repairs on coronary vessels
(source: Medtronic Inc.)
August
7, 2002
NIH
Launches Large Clinical Trial on EDTA Chelation
Therapy for Coronary Artery Disease
The 5-year Trial To Assess Chelation Therapy (TACT) will involve over 2,300
patients at more than 100 research sites across the country. "The public
health imperative to undertake a definitive study of chelation therapy is clear.
The widespread use of chelation therapy in lieu of established therapies, the
lack of adequate prior research to verify its safety and effectiveness, and
the overall impact of coronary artery disease convinced NIH that the time is
right to launch this rigorous study," said Stephen E. Straus, M.D., NCCAM
Director. The NCCAM has provided an extensive
FAQ about this study.
(source: National Center for Complementary and Alternative Medicine)
August 1, 2002
The
Tale of Two Heart Drugs: Study compares drugs
used in angioplasty
A study in this week's The Lancet clarifies
the differences between tirofiban and abciximab,
two drugs used with angioplasty patients to reduce
platelet "clumping" in the coronary
arteries. The conclusion is that both drugs are
similar in preventing death, heart attacks and
repeat surgery in the long-term, while abciximab,
the more expensive of the two, is better within
the first 30 days
(source: Robert Preidt. HealthScoutNews)
July
31, 2002
Drug-eluting
Stents To Receive Incremental Reimbursement
This precedent-setting decision by the U.S. Department of Health and Human
Services includes new payment
rates for drug-eluting stent technology, effective April 1, 2003, breaking
new ground by establishing new DRGs and setting a reimbursement before the
approval of a new medical device.
(source: Cordis Corporation)
July
30, 2002
Guidant
Agrees to Acquire Cook Group Incorporated
Ronald W. Dollens, president and CEO, Guidant Corporation, stated "This
agreement is strategically important as it adds clarity around our ability
to fully participate in the drug eluting stent market opportunity." The
press release also states "Guidant's obligation to complete the acquisition
is subject to certain clinical and legal conditions relating to the ACHIEVE Drug
Eluting Coronary Stent System. The conditions include positive clinical results
and Guidant's rights to use certain clinical data and to sell the ACHIEVE product." Also
read Cook's
press release about the proposed merger.
(source: Guidant Corporation / Cook Group Inc.)
July
29, 2002
Air
pollution linked with risk for exercise-induced
heart damage
Breathing polluted air, especially smoky exhaust that billows from factory
smokestacks and the tailpipes of some diesel-powered buses and trucks, is bad
for people with heart disease, according to a Finnish study, the first of its
kind, published today in Circulation: Journal of the American Heart Association.
(source: American Heart Association)
July 29, 2002
Clot-Busting
Protein May Lead to Clogged Arteries
Urokinase-type plasminogen activator, a naturally-occurring protein that is
commonly used as a clot-busting drug, may worsen atherosclerosis if it is supplied
in large quantities through gene therapy, the results of a new study suggest.
(source: Linda Carroll, Reuters Health)
July 22, 2002
American
Heart Association responds to recent media coverage
about high-fat, low-carbohydrate weight loss
diets
AHA President Robert Bonow, MD writes, "Many Americans may be understandably
confused by the recent surge of media interest in the role of high-fat, low-carbohydrate
diets for weight loss, spurred in part by an article in the July 7 issue of
the New York Times Magazine. The article supports the theory that a low-fat
diet and refined carbohydrates are at the root of Americas obesity epidemic,
and that a high-fat, low-carbohydrate diet, such as the
one recommended by best-selling book author Robert Atkins, M.D., might be good
for an individuals health." You can purchase
the original article, titled "What if It's All Been a Big Fat Lie?" from
the New York Times (or read it in your local library for free). You
can also read
Dr. Dean Ornish's commentary on the controversy.
(source: American Heart Association / New York Times / Dean Ornish,
WebMD)
July 22, 2002
More
fallout from plaque ruptures in store for heart
attack survivors
The blood clot that causes a heart attack may not act alone. Hidden plaque
ruptures may cause further damage, according to a three-dimensional ultrasound
study published in todays rapid access issue of Circulation: Journal
of the American Heart Association. An accompanying editorial says the ability
to diagnose vulnerable lesions before
they rupture would have tremendous potential for heart attack prevention.
IVUS and other invasive and noninvasive techniques could allow doctors to assess
individual plaques and overall plaque condition. (Read
more about Intravascular Ultrasound.)
(source: American Heart Association)
July 19, 2002
Boston
Scientific Announces Creation of Philanthropic
Foundation
Boston Scientific Corporation announced the creation of the Boston Scientific
Foundation, a philanthropic organization whose mission is to improve the health
of individuals and communities, and to enhance educational opportunity. The
Company has funded the Foundation with an initial $18 million endowment.
(source: Boston Scientific Corporation)
July 18, 2002
Braves
announcer Skip Caray back on the air after angioplasty
Atlanta Braves announcer Skip Caray expects to return to the broadcast booth
on July 18 after having angioplasty to clear an artery.
(source: Associated Press)
July
16, 2002
New
heart guidelines stress youth checks
Starting at age 20, every person in the United States should be regularly evaluated
for the risk of having a heart attack or stroke, according to landmark guidelines
issued today by the American Heart Association (read the guidelines here
-- HTML version / PDF
version). The recommendations mark the first time the group has suggested
routine screenings for all patients beginning in early adulthood.
(source: Adam Marcus, HealthScout / American Heart Association)
July 16, 2002
Drug
combo curbs artery re-closing after some heart
attacks
Aspirin plus the anticoagulant drug coumarin is more effective than aspirin
alone at keeping coronary arteries open after some heart attacks, researchers
report in todays rapid access issue of Circulation: Journal of the
American Heart Association.
(source: American Heart Association)
July 10, 2002
Medtronic
Challenges $169 Million Award to Boston Scientific
Medtronic is seeking to block enforcement of an arbitration award granted to
Boston Scientific and two company units in a dispute over a patent for stent
delivery systems. The arbitration panel stated that Medtronic willfully infringed
Schneider's patent. The panel ordered Medtronic to stop selling any devices
that violate the patent and awarded $169 million in damages to Boston Scientific
and its two units, plus costs and attorney fees.
(source: Susan Decker, Bloomberg)
July 9, 2002
Boston
Scientific Increases Equity Position in Natural
Pharmaceuticals, Inc.
Boston Scientific Corporation has acquired additional shares of the company.
In addition, NPI has granted Boston Scientific a long-term extension of the
exclusive paclitaxel supply relationship that is currently in place between
the companies. Paclitaxel is the active pharmaceutical compound in Boston Scientific's
drug-eluting stent technology.
(source: Boston Scientific Corporation)
July 8, 2002
Cordis
Introduces Bx SONIC Over-the-Wire Coronary
Stent with Advanced Tip Technology for Treatment
of Coronary Artery Disease
This product is indicated for improving coronary luminal diameter in patients
with symptomatic ischemic heart disease due to de novo (previously untreated)
and restenotic lesions in native coronary arteries with reference diameters
from 3.0mm to 5.0mm. The Bx SONIC Stent is also indicated for the treatment
of abrupt or threatened vessel closure in patients with failed interventional
therapy in lesions with reference diameters from 2.25mm to 4.00mm.
(source: Cordis Corporation)
July 4, 2002
Exercise
Boosts Cholesterol-Lowering Diet Effects
Yet another study has demonstrated the considerable health benefits of moderate
exercise. In a study of people with heart disease who were trying to lower
their cholesterol levels by sticking to a reduced-fat diet, adding an average
of just 30 minutes a day of moderate exercise helped most reach their cholesterol
goals.
(source: Reuters Health)
July 4, 2002
Doctors
worry new study will encourage couch potatoes
to stay put
A newly published study suggests deaths from heart disease and stroke would
be reduced dramatically if more
seemingly healthy people used cholesterol-lowering drugs. A Toronto dietary
expert worries those findings may encourage couch potatoes to stay put.
(source: Helen Branswell, Canadian Press)
June 27,
2002
Court
Issues Written Opinion in Boston Scientific-Cook
Dispute
The court found in its written opinion that the Cook-Guidant agreements constituted "a
de facto sublicense" that was "neither authorized, permitted, nor
lawful." The court characterized the Cook-Guidant agreements as a "sham" and
wrote that Cook's "actions cannot be countenanced." The court found
that the Angiotech agreement "clearly evinces an intent that only Cook
and Boston (Scientific) are to be players in the paclitaxel business."
(source: Boston Scientific Corporation)
June
25, 2002
Dutch
study bolsters evidence that statins help patients
after angioplasty
Angioplasty patients may survive longer, with fewer recurring heart problems,
if they start taking cholesterol-lowering drugs called statins soon after the
procedure, Dutch research suggests. Benefits were found even in patients with
normal cholesterol levels who took fluvastatin, sold in the United States under
the brand name Lescol. The research was funded and coordinated by Novartis
Pharma AG, which makes Lescol. The study (read
abstract here) bolsters previous research on the heart benefits of
early statin use. But this study followed patients for longer and found the
effects can last at least four years. (Also see next article.)
(source: Lindsey Tanner, Associated Press / Journal of the American
Medical Association)
June 25, 2002
Cholesterol
Drug Cuts Post-Surgery Heart Problems
Even people with normal cholesterol levels may benefit from cholesterol-lowering
drugs after undergoing procedures to clear clogged coronary arteries, new research
suggests. Researchers found that giving the cholesterol drug fluvastatin (Lescol)
to patients with average cholesterol counts cut their risk of heart attack
and other major cardiac problems after surgery.
(source: Reuters Health)
June 24, 2002
Doctors
say pitcher Kile's fatal problem is common, preventable
The heart condition linked to the death of St. Louis Cardinals pitcher Darryl
Kile is common and treatable, and should have been suspected, given his family
history, doctors said Monday. An autopsy showed the 33-year-old pitcher found
dead Saturday had 80 per cent to 90 per cent narrowing of two of three main
arteries to his heart. also read
about a test that can predict risk of sudden cardiac death (SCD).
(source: Associated Press / Cambridge Heart)
June 23, 2002
There
is bias in heart attack care, but it's related
to age, not gender says study
About a study published Wednesday in the Journal of the American College of
Cardiology, lead author Dr. David Alter says, "We really do under-treat
the elderly. We under-treat them with our best evidence-based medicines. We
probably under-dose them to some extent. And this study would support that
when it comes to our more specialized interventions - like angiography and
the intensity of followup (in cardiac care) and things like that - we are also
less aggressive."
(source: Helen Branswell, Canadian Press)
June 18, 2002
Boston
Scientific Submits Application for CE Mark for
its TAXUS Paclitaxel-Eluting Stent System
The Company also announced that after receiving regulatory approvals in additional
countries, it has expanded the commercialization of the TAXUS product through
the WISDOM transitional registry program. Boston Scientific is conducting the
registry in a number of countries as part of a limited commercial launch.
(source: Boston Scientific Corporation)
June 13, 2002
Court
Rules In Favor Of Boston Scientific In Paclitaxel-Coated
Stent Dispute With Cook
Boston Scientific Corporation announced today that the United States District
Court for the Northern District of Illinois ruled in its favor in the dispute
between Boston Scientific and Cook Inc. over Cook’s agreements with Guidant
Corp. relating to paclitaxel-coated stents.
(source: Boston Scientific Corporation)
June 13, 2002
Guidant
Reaffirms Commitment to Paclitaxel Eluting Stent
Program
Guidant comments on Summary Judgment Ruling in Cook-Boston Scientific Litigation: "Guidant
continues to believe that Cook has the right to enter into a distribution agreement
with Guidant. We are disappointed with the judge's ruling, which Cook plans
to appeal," stated Ronald W. Dollens, president and CEO, Guidant Corporation.
(source: Guidant Corporation)
June 13, 2002
Cook
Incorporated To Appeal Federal Court Ruling Against
Selling Paclitaxel-Eluting Stents Through A Third-Party
Distributor
"We strongly felt the language of our licensing agreement with Angiotech
clearly granted us the option to distribute paclitaxel-coated devices through
a third-party distributor, and we're very disappointed the court's opinion did
not uphold this right," said Phyllis McCullough, chairman of Cook Incorporated.
(source: Cook Group Inc.)
June 11, 2002
Boston
Scientific Wins Infringement Case in Germany
on Medtronic's Rapid Exchange Stent Delivery
Systems and Angioplasty Balloons
The German patent involved in the case was granted to Dr. Tassilo Bonzel, and
is a counterpart of the U.S. patent that an arbitration panel last year ruled
had been willfully infringed by Medtronic. In that proceeding, the panel awarded
Boston Scientific $169 million in damages, as well as costs and attorneys'
fees, and a permanent injunction. The arbitrators' decision has been confirmed
by a U.S. District Court, but Medtronic has appealed the decision.
(source: Boston Scientific Corporation)
June 5, 2002
Antibiotic-Coated
Stents Look Promising; Drug from Easter Island
helps prevent re-closing
Sirolimus is sold by Wyeth-Ayerst as Rapamune, named in part after what native
Easter Islanders call their remote South Pacific enclave -- Rapa Nui. The idea
is that eluting sirolimus will prevent the growth of new tissue that often
causes the treated artery to close up again. And a report in tomorrow's New
England Journal of Medicine, by cardiologists at 19 European medical centers,
says that it works.
(source: Ed Edelson, HealthScoutNews)
June 4, 2002
Boston
Scientific Announces Progress in TAXUS IV U.S.
Clinical Trial
1,172 patients have been enrolled in the TAXUS IV paclitaxel-eluting stent
clinical trial, the target patient number for the trial which is designed to
collect data to support regulatory filings for U.S. product commercialization.
The prospective, randomized, double-blind study will assess the safety and
efficacy of a slow-release dose formulation paclitaxel-eluting TAXUS stent
system for the treatment of coronary restenosis. The TAXUS IV trial is using
the Express stent, a laser-cut, balloon-expandable stent developed exclusively
by Boston Scientific.
(source: Boston Scientific Corporation)
June 3, 2002
New
marker of inflammation predicts death from artery
disease
People with coronary artery disease who had high blood levels of an inflammatory
marker called interleukin18 (IL18) had more than triple the risk
of death from cardiovascular disease than those with the lowest levels, researchers
report in today's rapid track publication of Circulation: Journal of the
American Heart Association.
(source: American Heart Association)
May 31, 2002
Guidant's
Market-Leading MULTI-LINK PENTA Stent Demonstrates
Excellent Clinical Data
The clinical trial, involving 200 patients with de novo (previously untreated)
native coronary artery lesions, demonstrated a 17.5 percent binary restenosis
rate. "The low restenosis rate for the MULTI-LINK PENTA is particularly
impressive because it was achieved in lesions that were long and complex," said
Dr. Jeffrey Popma of Brigham & Women's Hospital, principal investigator
for the study. The mean lesion length was 12.9 mm, which is longer than in
previous MULTI-LINK trials. In addition, more than 83 percent of the patients'
lesions were of a complex morphology.
(source: Guidant Corporation)
May 28, 2002
Boston
Scientific Announces CE Mark for Symbiot Covered
Stent System
The Symbiot Covered Stent is specifically designed to address the two major
limitations of treating saphenous vein graft (SVG) disease: the risk of plaque
embolization during the procedure and poor long-term outcomes. The stent system
features a self-expanding nitinol stent encased in a thin porous ePTFE polymer
membrane. The ePTFE cover and self-expanding deployment are intended to work
together to reduce plaque embolization during the stenting procedure and provide
a long-term patient benefit by reducing restenosis.
(source: Boston Scientific Corporation)
May 23, 2002
Guidant
Announces Excellent Preliminary Results of Paclitaxel
Eluting Stent Trial
"These promising preliminary results add to the growing repository of clinical
data demonstrating the potential benefit of paclitaxel eluting stents for treating
coronary artery disease," said Dr. Knopf. William Knopf, M.D., of St. Joseph's
Hospital in Atlanta, Georgia., co-principal investigator of the trial.
(source: Guidant Corporation)
May 23, 2002
Boston
Scientific Announces Final Results of its TAXUS
III Paclitaxel-Eluting Stent Clinical Trial
"This is powerful data that provides further evidence that TAXUS paclitaxel-eluting
stents hold great promise for the treatment of in-stent restenosis and coronary
artery disease," said Jim Tobin, President and Chief Executive Officer of
Boston Scientific. "This data highlights the importance of stent placement
accuracy and complete coverage of the treated or diseased portion of the vessel
with a paclitaxel-eluting stent. Further optimization in stent deployment and
placement is likely to yield even better outcomes. This is a first and significant
step toward expanding the role of TAXUS paclitaxel-eluting stents into more complex
lesions."
(source: Boston Scientific Corporation)
May 22, 2002
Guidant
Begins Clinical Trial of New Stent to Treat Bifurcated
Lesions
The first patient has been treated in a clinical study that will evaluate the
safety and performance of Guidant's new MULTI-LINK FRONTIER Coronary
Stent System which is designed to treat atherosclerotic lesions in native coronary
arteries at the site of a bifurcation, where one vessel branches from another.
Bifurcated areas of the vascular system are a common location for the build-up
of atherosclerotic plaque. These lesions are particularly challenging to treat
with currently available stents because of the risk of blocking blood flow
to the side vessel. About 20% of patients treated for coronary artery disease
are treated for bifurcated lesions.
(source: Guidant Corporation)
May 22,
2002
Preliminary
Results of Large-Scale U.S. Study Support Excellent
Results with Cordis CYPHER Sirolimus-eluting
Stent
We are extremely impressed by the consistency in findings between the preliminary
SIRIUS data and the results of the large-scale RAVEL* study in Europe and Latin
America, said Dr. Martin Leon of Lenox Hill Hospital in New York City.
Eight-month angiographic follow-up showed virtually no in-stent late lumen loss
(0.14mm) in patients treated with the CYPHER Stent, mirroring the 6-month
findings of the RAVEL study and the 2-year findings of the First in Man study.
The 2% rate of angiographic in-stent restenosis representing a 94% reduction
versus the control arm (bare metal stent) supports the findings of earlier
studies.
(source: Cordis Corporation)
May 21, 2002
Boston
Scientific Announces CE Mark for Express2 Coronary
Stent System
The Express2 stent system -- an Express stent combined with advanced
Maverick® balloon catheter technology -- features a laser-bonded, flexible
tip with a long, low profile designed for easier tracking. The Bioslide® hydrophilic
coating is designed to reduce friction, while the proprietary Crimp 360 technology
secures the stent to the balloon.
(source: Boston Scientific Corporation)
May 16, 2002
First
Patients Enrolled In Clinical Trial Of Guardwire
Plus In Patients With Acute Myocardial
Infarction
In a study intended to further demonstrate the safety and effectiveness of
balloon occlusion distal protection during vascular interventions, Medtronic,
Inc., today announced the start of its EMERALD (Enhanced Myocardial Efficacy
and Recovery by Aspiration of Liberalized Debris) trial. The study is specifically
designed to compare results in patients with acute myocardial infarction (AMI),
half of whom will be randomized to the new generation .028 inch GuardWire Plus Temporary
Occlusion and Aspiration System, while the other half will receive conventional
percutaneous interventional therapy (PCI) without embolic protection.
(source: Medtronic, Inc.)
May 16, 2002
Boston
Scientific Announces Court Decision to Set Aside
Infringement Verdict in J&J Case
"We are very pleased by the court's decision to set aside the jury's verdict," said
Jim Tobin, President and Chief Executive Officer of Boston Scientific. "This
is a major vindication of our position that the NIR® stent technology does
not infringe any of the J&J patents."
(source: Boston Scientific Corporation)
May 15, 2002
FDA
Approves Release of Medtronic's Revolutionary
Stormer Balloon Catheter
The company announced approval by the U. S.Food and Drug Administration of
its Stormer Over-the-Wire (OTW) Balloon Dilatation Catheter system used
in the treatment of coronary artery disease. The new Stormer, designed specifically
to treat challenging lesions, is now available for immediate release in the
U.S. and "represents a major advance over other such catheters on the
market today."
(source: Medtronic Inc.)
May 15, 2002
Guidant
Debuts Latest Coronary Stent in Europe; Sixth-Generation
Stent System Features Enhanced Deliverability,
Market-Leading Stent Design
he MULTI-LINK ZETA System incorporates a new delivery platform featuring a
softer, more flexible balloon material designed to enhance delivery to the
site of the coronary blockage and promote smooth deployment. The new system
leverages the proven design of the MULTI-LINK PENTA Stent, the market
leading stent launched in mid-2001.
(source: Guidant Corporation)
May 13, 2002
Radiation
rids arteries of re-narrowing for up to five
years
People who received radiation in their arteries during angioplasty had a reduced
risk of artery renarrowing for up to five years compared to those who got only
angioplasty, according to a report in today's Circulation: Journal of the
American Heart Association.
(source: American Heart Association)
May 9, 2002
Medtronic
Signs Strategic Agreements With Abbott Laboratories,
Gains Access To Drug Compounds And Coating Technologies
For Drug-Eluting Stent Program
Under the agreements, Abbott will grant Medtronic co-exclusive access to its
proprietary immunosuppression drug ABT-578 (a rapamycin analogue) -- for use
in Medtronics drug-eluting stent program -- as well as the phosphorylcholine
(PC) coating it has licensed from Biocompatibles International plc for use
in conjunction with ABT-578.
(source: Medtronic Inc.)
May 7, 2002
Thomas
J. Linnemeier, M.D., Chief Medical Officer, Vascular
Intervention, Guidant Corporation, Suffers Fatal
Injuries in Automobile Accident
Tom Linnemeier was not only one of the pioneers of interventional cardiology,
having adopted this technology when it was not fashionable, he was also "a
nice guy". He will be missed by all. (Editor, Angioplasty.org)
(source: Guidant Corporation)
May 7, 2002
Drill
and suction procedure holds promise for clogged
arteries
The X-sizer, a device that sucks out blood clots during angioplasty, may improve
survival, according to one of the first studies of its kind published in today's
rapid access issue of Circulation: Journal of the American Heart Association.
Researchers used a marker of heart function called an ST-segment score, calculated
during an electrocardiogram. A rapid decrease in ST-segment score, or resolution,
indicates better blood flow in coronary vessels and the better the patient
will fare overall. ST-segment resolution was observed immediately after treatment
in 83 percent of patients treated with suction plus angioplasty, compared with
52 percent of those who had angioplasty alone.
(source: American Heart Association)
May 6, 2002
Guidant
Launches Next Generation of Market-Leading Guide
Wire
"The new HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire improves upon
an already excellent product, allowing easy and smooth stent delivery," said
Dr. Martin B. Leon of Lenox Hill Hospital in New York City.
(source: Guidant Corporation)
May 2,
2002
Boston
Scientific Announces FDA Authorization for Full
Enrollment Of TAXUS IV Clinical Trial
The TAXUS IV clinical trial, designed to assess the safety and efficacy of
a slow-release dose formulation paclitaxel-eluting TAXUS stent system
for the treatment of coronary restenosis, has now been given approval by the
FDA, allowing the company to enroll its full complement of up to 1172 patients
at up to 80 sites. The company states that TAXUS IV is a pivotal study designed
to collect data to support regulatory filings for U.S. product commercialization.
TAXUS I showed 0% restenosis and 0% thrombosis. The second and third trials
confirmed safety and positive results for treatment of in-stent restenosis.
(source: Boston Scientific Corporation)
May 2, 2002
Guidant
Initiates New International Paclitaxel Eluting
Stent Trial
Guidant announces enrollment of the first patient in a new international clinical
study, called DELIVER II, designed to evaluate the benefit of the paclitaxel-coated
ACHIEVE Drug Eluting Coronary Stent System. Target enrollment is up to
1,500 patients in 100 centers outside the United States. Data from this trial,
which will be conducted on behalf of Cook Inc., may be used to expand indications
for the ACHIEVE Stent System beyond those outlined in Cook's ASPECT and ELUTES
trial protocols.
(source: Guidant Corporation)
April 17, 2002
Radiation
helps keep arteries open; method could prevent
reclogging of vessels after bypass
Researchers at Washington Hospital Center tested radiation on 120 bypass patients
who had clogged stents. They found that those who got the radiation were only
half as likely as other patients during the following year to die, have a heart
attack or experience new re-narrowing of their graft. (Read
the abstract of the study published in the New England Journal of Medicine.)
(source: MSNBC / New England Journal of Medicine)
April
17, 2002
A
Call for Change in Cardiac Care
Today's front page New York Times article (registration required) reports
on an important meta-study of several randomized trials. The study concludes
that for patients suffering from acute myocardial infarction (heart attack)
angioplasty is the superior treatment over thrombolytic therapy ("clot-buster" drugs),
even if the patient must be transported to a more distant hospital where angioplasty
can be performed in a catheterization lab. The original study by Thomas Aversano,
MD of Johns Hopkins and appearing in today's issue of the Journal of the
American Medical Association (get
abstract here) states "...compared with thrombolytic therapy,
treatment of patients with primary PCI at hospitals without on-site cardiac
surgery is associated with better clinical outcomes for 6 months after index
MI and a shorter hospital stay." "The implications of these trials
are profound", states Christopher P. Cannon, MD, of Brigham and Women's
Hospital and Harvard Medical School, in an
accompanying article, especially when one considers that an estimated
two-thirds of the more than one million Americans who have heart attacks annually
do not have access to angioplasty. Join
the discussion thread on this topic (first started five years ago!!).
And look for our upcoming featured interview with Geoffrey Hartzler, MD who
pioneered the treatment of acute MI with angioplasty almost two decades ago.
(source: Lawrence K. Altman, New York Times / Journal of the American
Medical Association)
April 16, 2002
Angioplasty
safe for the heartland
A "popular press" report on the above study. It states: "Numerous
studies have shown angioplasty is the
best treatment for heart attacks. But some medical standards and state regulations
say doctors should perform angioplasties only at hospitals that have a cardiac
surgery unit in case something goes wrong. The new study challenges that thinking."
(source: MSNBC)
April 15, 2002
Cordis CYPHER Sirolimus-eluting
Stent Receives CE Mark Approval
The company today reported its new CYPHER Sirolimus-eluting Stent received
CE Mark approval in Europe for
treatment of de novo coronary artery lesions (less than or equal to 30 mm in
length) in native coronary arteries with reference diameters ranging from 2.25
to 5.0 mm.
(source: Cordis Corporation)
April 4, 2002
New
Tack on Attacks
When treating heart attacks, a new study from Denmark (DANAMI II) suggests
that angioplasty in the cath lab beats clot-busters in the emergency room.
(source: ABC News)
April 2, 2002
Boston
Scientific Announces First Human Use In U.S.
Of Its Paclitaxel-Eluting Coronary Stent
System
The company announced that the first patients in the TAXUS IV trial have been
treated at a number of sites, including Lenox Hill Hospital in New York."The
implantation of the first polymer-based, paclitaxel-eluting stent in the U.S.
is a major step on the road to a cure for symptomatic coronary artery disease,''
said Gregg Stone,
M.D., the Principal Investigator for the trial and Director of Cardiovascular
Research and Education at the Cardiovascular Research and Lenox Hill Heart
and Vascular Institute. The TAXUS IV trial was approved by the FDA one week
ago (see
related article) and was hailed as "...the green light to begin
one of the most important trials in our company's history,'' by Jim Tobin,
President and Chief Executive Officer of Boston Scientific.
(source: Boston Scientific Corporation)
March
27, 2002
Stents
Help Keep Blood Flowing After Heart Attack
The CADILLAC trial results have been published in the New England Journal of
Medicine (read
abstract). The study, headed by Dr. Gregg W. Stone, of the Cardiovascular
Research Foundation at Lenox Hill Hospital in New York, showed that heart attack
(acute MI) patients who had a stent implanted after undergoing balloon angioplasty
were less likely to have a heart artery re-blockage than patients treated with
angioplasty alone.
(source: Reuters / New England Journal of Medicine)
March 20, 2002
Miracle
ICD Study Results Presented at ACC
Sponsored by Medtronic, Inc., results of the MIRACLE ICD clinical study were
presented by Dr. James Young, co-principal investigator, at todays late-breaking
clinical trials segment of the 51st annual Scientific Sessions of the American
College of Cardiology (ACC), and demonstrated improved quality of life, functional
capacity and exercise tolerance for patients with advanced heart failure and
a risk for dangerous ventricular arrhythmias.
(source: Medtronic, Inc.)
March
19, 2002
Boston
Scientific Announces Preliminary Results of its
TAXUS III Paclitaxel-Eluting Stent Clinical Trial
Six-month data from this trial of in-stent restenosis showed a MACE (Major
Adverse Cardiac Event) rate of 17%. This compares favorably with brachytherapy
(radiation treatment) without any of the associated risks and complexities.
The patient group represents patients with complex vascular disease having
recurrent occlusion in a stent, who tend to have an increased probability of
restenosis. In the trial, the newly occluded original uncoated stent was opened
with a balloon, and a new coated stent inserted inside of the original one.
(source: Boston Scientific)
March
19, 2002
Statins
Cut Mortality After Artery-Clearing Procedure
Statins normally are used to reduce cholesterol in patients. However, this
study shows that the use of statins in angioplasty patients reduces post-procedure
mortality by over one-third. The effects seemed to be independent of cholesterol
levels, gender, presence of diabetes or unstable angina.
(source: Emma Hitt, PhD, Reuters Health)
March 19, 2002
Results
Of Landmark SAFER (Saphenous Vein Graft Angioplasty
Free of Emboli Randomized) Study Published In
Circulation
The article describes the largest ever randomized study of balloon-based distal
protection technology in patients with diseased saphenous vein grafts. Results
demonstrated a 42% relative reduction in major adverse clinical events (MACE)
after using the GuardWire Plus system. The first-of-its-kind system, which
has been available in the U.S. since last year, protects against potentially
catastrophic events in patients undergoing diseased saphenous vein graft stenting.
(source: Medtronic, Inc.)
March 19, 2002
Guidant
Announces Opening of Virtual Reality Physician
Training Facility
The system, based in Brussels, is a simulator for catheter-based procedures
such as stent placement, balloon angioplasty and coronary sinus lead placement
required for cardiac resynchronization therapy. The newly opened facility offers
eight simultaneous sessions allowing physicians to practice cases and share
their experiences in a natural learning environment.
(source: Guidant Corporation)
March 19, 2002
Age
a Barrier to Aggressive Heart Treatment
"Use of invasive procedures drops with age, precipitously after age 75," says
Dr. Karen Alexander, a professor of medicine at Duke University Medical Center
who presented a report on the finding today at the annual scientific session
of the American College of Cardiology in Atlanta. "It is important that
health-service researchers look at whether this is appropriate, or whether some
people who we do not treat could benefit from the procedures."
(source: HealthScoutNews)
March 18, 2002
UK's
Biocompatibles sells stent unit to Abbott
Biocompatibles is selling its cardiovascular stent business and related drug
programmes to U.S.-based Abbott Laboratories for 164.7 million pounds ($235
million).
(source: Abbott Laboratories)
March
17, 2002
Coated
Stents Hold Promise for Angioplasty Dilemma
Results from trials reported at the American College of Cardiology are confirming
that coated stents may prove to be the solution to the dilemma of restenosis.
In the latest data on the Johnson & Johnson/Cordis Cypher stent which is
coated with the antibiotic Sirolimus, 0% restenosis was reported in the 43
patients followed over two years. A second study (RAVEL) also showed 0% restenosis
at 1 year (compared to 26% in the control group). Interesting in this study
was the existence of a subgroup of diabetic patients, also with 0% restenosis
(normally these patients are referred to surgery as the restenosis rate for
diabetics is normally greater than 40%).
(source: MSNBC / CNN /
ABC News / Cordis)
March 17, 2002
Boston
Scientific Files for FDA Approval of Express and
Express2 Coronary Stent Systems
Paul LaViolette, President, Boston Scientific Cardiovascular, states "The
Express stent system technology has enormous potential, including a broad range
of applications which we believe will include peripheral vascular and neurovascular,
in addition to coronary applications. We also plan to use the Express2 stent
system as the platform for our drug-eluting stent program." The company
also announced several other device approvals from the FDA.
(source: Boston Scientific Corporation)
March 15, 2002
FDA
clears new Philips X-ray system that will enable more precise
care for cardiac patients
The company announces that the FDA has cleared the Integris Allura Flat Detector
catheterization lab for use in
cardiac procedures. The new X-ray imaging system enables clinicians to see
and work in the smallest vessels of the heart, while reducing X-ray exposure
and procedure times for them and their patients.
(source: Philips Medical Systems)
March 14, 2002
To
Curb Medical Errors, Patients Should 'Speak Up'
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
in collaboration with the Centers for Medicare and Medicaid Services (CMS)
have launched a national campaign, titled "Speak Up", to promote
the fact that patients must play an active role in preventing healthcare errors
by speaking up when they see something amiss. We at the Angioplasty PTCA Home
Page endorse this position and believe, as many of the top interventional cardiologists
do, that these procedures, in which the patient is awake, are a prime example
of a doctor-patient partnership.
(source: Joint Commission on Accreditation of Healthcare Organizations)
March 14, 2002
Guidant
Introduces New Product for Treating Peripheral Vascular
Disease
The company has received FDA clearance to market the new AGILTRAC .018
Peripheral Dilatation Catheter for treating peripheral vascular disease. An
estimated 10 million patients in the United States alone suffer from peripheral
vascular disease (PVD), which is a condition characterized by blockages in
vessels supplying the kidneys and limbs.
(source: Guidant Corporation)
March 12, 2002
Hospital
'Report Cards' Get Mediocre Grade
A report in the Journal of the American Medical Association finds that so-called "hospital
report cards" are not necessarily indicative of the best medical care
-- sometimes reputation and "word-of-mouth" may be more accurate.
(source: By Adam Marcus, HealthScoutNews)
March 11, 2002
Antibiotics
May Prevent Second Heart Attack
In the current Circulation, a Finnish study of 148 heart-attack showed that
those who took a 3-month course of the antibiotic clarithromycin were 41% less
likely to have another cardiovascular "event" during the 18 months
than the placebo group.
(source: Reuters Health)
March 11, 2002
Heart
Disease is Leading Cause of Death in Women
A short TV news story that highlights the sometimes overlooked fact that "11
times as many women die of heart disease than the leading causes of death combined."
(source: News Channel 5, Cleveland/Akron, Ohio)
March 11, 2002
Pollution
Constricts Blood Vessels, Study Finds
Air pollution causes the blood vessels of healthy people to close up, which
helps explain why high levels of pollution are linked not only to breathing
problems but also to heart attacks and other cardiovascular problems. The U.S.
Environmental Protection Agency estimates that air pollution contributed to
60,000 heart-related deaths in 1996.
(source: Maggie Fox, Reuters)
March 10, 2002
Clot-buster
drugs can put elderly at risk
Clot-busting drugs that save thousands of heart attack patients each year can
result in life-threatening bleeding when given to certain elderly patients,
states a study from Harvard Medical School. However, a co-author of the study
cautioned, "In no way do I think this study supports the recommendation
that elderly patients shouldn't be treated." Rather, he says, the study "suggests
strongly that physicians have to be very careful in their decision-making,
selecting only appropriate patients." He said doctors must consider alternatives
to clot-busters, including immediate balloon angioplasty.
(source: Steve Sternberg, USA Today)
March 7, 2002
Guidant
Halts Further Development on Actinomycin-D Drug Eluting
Stent Program
Preliminary results (first 90 patients) of Guidant's ACTION clinical trial
study indicate that actinomycin-D is not effective in preventing restenosis
and patients treated with actinomycin-D eluting stents have an unacceptably
high target lesion revascularization rate. In the interests of the patients,
the trial has been halted by Guidant.
(source: Guidant Corporation)
March 4, 2002
Heart
Risk May Rebound After Stopping Statins
Among patients with acute coronary syndrome who were taking statins, those
who stopped taking the drugs after being hospitalized for chest pain were nearly
three times as likely to have a heart attack or die as those who kept taking
the cholesterol-lowering drugs, according to a report in the March 26th issue
of Circulation.
(source: Reuters Health)
February 27, 2002
Guidant
Announces CE Mark Approval of Next Generation Lead for
Use with Heart Failure Devices
The EASYTRAK 2 lead design allows the physician to position the pacing electrodes
in a vein on the left side of the heart using an over-the-wire technique similar
to the system used in angioplasty procedures -- another case of how the basic
concept of using the circulatory system as a "highway for therapy" developed
by the pioneers of angioplasty, has expanded to treating many other disease
conditions.
(source: Guidant Corporation)
February 21,
2002
Operation
on Fetus's Heart Valve Called a 'Science Fiction' Success
In a demonstration of how coronary angioplasty techniques and devices have
affected medicine as a whole, a surgical team at Childrens Hospital in Boston
was able to prevent the development of hypoplastic left heart syndrome by operating
on a fetus to open a closed heart valve, using an angioplasty balloon -- the
first time in the United States this defect has ever been corrected in a fetus.
(source: Children's Hospital Boston)
February 11,
2002
Boston
Scientific Announces First Human Use of Carotid Stent System
in United States
A stent used to open the carotid (neck) artery has been combined with a low
profile filter to prevent embolic debris from travelling to the brain during
the procedure. The procedure was performed at the Arizona Heart Institute and
is part of a new U.S. clinical trial that may include up to 775 patients at
40 sites.
(source: Boston Scientific)
February 1, 2002
Cardiac
catheterization: Where are we in 2002?
This article (free registration required) by George W. Vetrovec, MD and Spencer
B. King III, MD is an interesting overview about how the use of cath labs increased
after Andreas Gruentzigs pioneer coronary intervention in 1977.
(source: Cardiology Today)
February 1, 2002
Many
Heart Attack Patients Miss Out on Treatment
A new international study in The Lancet states that 1 in 3 patients having
a serious heart attack may not be given emergency treatment to restore blood
flow. These treatments are normally "clot-busting" drugs or angioplasty.
The patients tended to be those over the age of 75, those without chest pain
and those with a history of diabetes, congestive heart failure, heart attack
or heart bypass surgery.
(source: Keith Mulvihill, Reuters Health / The Lancet)
February 1, 2002
Women,
Elderly Wait Longer for Heart Attack Care
In two different studies over a 7-year-period, it has been found that elderly
individuals, females, diabetics and minorities continue to experience delays
in both arriving at the hospital after having heart attack symptoms and receiving
timely treatment for those symptoms.
(source: Charnicia E. Huggins, Reuters Health / Annals of Emergency
Medicine)
February 1, 2002
Guidant
Announces Filing for European Approval to Market Drug Eluting
Stent
Guidant has filed for CE Mark approval to market the ACHIEVE drug eluting
paclitaxel-coated coronary stent in Europe. Paclitaxel acts to prevent excessive
cell re-growth (restenosis) at the site of the stent placement. Recent clinical
studies suggest that paclitaxel-coated stents have a positive impact on the
prevention of restenosis.
(source: Guidant Corporation)
January 30, 2002
New
Guidelines for Surgery in Heart Patients
The American Heart Association and the American College of Cardiology have
issued new guidelines on performing non-cardiac operations in people with heart
disease--highlighting, among other issues, the importance of delaying surgery
in patients who have recently had stents placed in clogged heart arteries.
(source: Reuters Health)
January 21, 2002
Cold
as ice: Opening arteries with cryoplasty
Experimental technique freezes away blockages. "It's
almost like the cells have a switch that's like a self-destruct
button," In apoptosis, "the body compartmentalizes
the cell -- sort of pinches off little pieces at a time
-- and removes it." That process is gentler on the
artery wall than angioplasty, preventing much of the inflammation
and scarring that contribute to restenosis, says Dr. James
Joye, director of peripheral vascular interventions at
El Camino Hospital in Mountain View, California. He's also
co-founder of CryoVascular Systems, the company that markets
the device used in the procedure.
(source: CNN)
January 18, 2002
Coated
Stents Performing Well in Trials
A good overview of the various coated stent clinical trials now underway and
some looks to the future.
(source: Btech Investor)
January 7, 2002
New
Blood Filtering Device Being Studied for Use During Angioplasty
Physicians at the UPMC Health System Cardiovascular Institute are beginning
a research study to test the effectiveness of a small basket-like filtering
device to capture particles in the blood that may be released during angioplasty.
(source: University of Pittsburgh Medical Center)
January 2, 2002
New
stent a potential breakthrough
Doctors are close to solving one of the biggest challenges in treating heart
disease. Initial tests with an improved version of the conventional stent show
it can open clogged arteries without the danger they will close up again. Now
a major trial of the device, which releases an immune-suppressing drug, is
underway.
(source: NBC Nightly News, Robert Bazell)
January 1, 2002
Heart
Disease Remains Top Killer In United States; One Third
Preventable
Almost 62 million Americans have some form of cardiovascular disease and nearly
one million die from the disease annually. While it's by far the top killer
(almost twice the cancer death rate) it is estimated that a third of these
deaths could be prevented by following basic guidelines such as better diet,
exercise and stopping smoking -- smoking is responsible for one in five of
these deaths.
(source: Washington Post) |