The following archived links to
news, company press releases and other information sources
are provided as a service by the Angioplasty / PTCA Home
Page, which is not responsible for the content found
on these external sites. If available, the primary source
or abstract which provides the basis for the article
is also listed.
If you wish a different date range,
select a news archive, or our special Drug-Eluting Stent
NewsCenter, from the following menu:
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 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 Association’s 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 Association’s 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 Association’s
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 Association’s 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 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 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
world’s 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.)
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 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 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 today’s 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.)
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 Guidant’s 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 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 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 today’s 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 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 today’s 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 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 interleukin–18 (IL–18) 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 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 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 today’s
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
