December
31, 2003
Not
a Lean Year for Health News
(Scroll down article) to read, "...the medical community can take some comfort
from continuing progress against the U.S.'s No. 1 killer -- heart disease. And
researchers learned again this year that often the simplest answers are the best
ones. Angioplasty...trumps clot-busting drugs for those suffering a heart attack...."
(source: Tim Smart, HealthDay)
December
16, 2003
Study
Links Pollution to Heart Disease
Air pollution in U.S. cities is twice as likely to cause death from heart disease
as respiratory ailments, say researchers in the latest issue of Circulation,
a publication of the American Heart Association
(source: Bobby Ross Jr., Associated Press)
December 13, 2003
Hospital's
Cath Lab: Care By Design
This story tells the value of having a cath lab in a small community in Rhode
Island.
(source: Gloria Russell, The Westerly Sun)
December 12, 2003
Ski
coach survives surprise heart attack
Interesting human interest story about how a high school ski coach in Little
Falls, Minnesota experienced a heart attack on the trail and still got himself
to the cath lab where an angioplasty was performed. Ten days later, he's back
at work.
(source: Star Tribune)
December
11, 2003
Proposed
cath-lab rules have providers worried; State
considers allowing angioplasty without heart
surgeons on location
Report from Washington State on the controversy over providing access to angioplasty
in rural areas without on-site surgical backup.
(source: Journal of Business, Spokane)
December
10, 2003
Emergency
cardiac monitoring strategy tested in ambulances
Under a UCSF-designed program, all ambulances in Santa Cruz County now are
equipped with sophisticated cardiac monitors that can send vital data directly
by cell phone to the emergency department of the receiving hospital. The story
is told of a heart-attack victim who collapsed on the road, dialed 911 and
wound up having his artery cleared via angioplasty only 48 minutes after arriving
at the hospital (the cath lab was prepped as he was being transported).
(source: University of California - San Francisco)
December
1, 2003
'They
wash the cholesterol out of my blood'
From the U.K., a report on a lipid-lowering procedure, called LDL Apheresis,
which is similar to dialysis and in certain cases may offer hope to those with
high cholesterol that doesn't respond to other treatments
(source: BBC News)
November
29, 2003
Discovery
of heart attack gene may help diagnose risk within
families
An extended family living in the American mid-west state of Iowa has helped
scientists to find the first gene that unequivocally causes heart attacks in
late middle-age. Eric Topol, MD of the Cleveland Clinic Foundation in Ohio
stated, "This stands out because of its potential impact. It's a great
first step towards understanding the basis of coronary artery disease at its
genetic roots."
(source: Steve Connor, Independent News UK)
November
25, 2003
Harvard
Health Letter Names Top Ten Health Stories of
2003
Coming in at #3: "Angioplasty is the best treatment for heart attacks:
Two studies this year have helped to establish angioplasty as the preferred
treatment for heart attack."
(source: Harvard Health Letter)
November
24, 2003
Impact
of Renal Insufficiency in Patients Undergoing
Primary Angioplasty for Acute Myocardial Infarction
A multi-center study in the American Heart Association journal Circulation states
that the "importance of renal insufficiency (RI) in patients undergoing
primary percutaneous coronary intervention (PCI) for acute myocardial infarction
(AMI) has not been well characterized and is associated with a markedly increased
risk of mortality, as well as bleeding and restenosis. Novel approaches are
needed to improve the otherwise poor prognosis of patients with RI and AMI."
(source: Circulation)
November
23, 2003
The
new plaque busters
A round-up of several studies involving new drugs that were presented at this
year's American Heart Association session and what they are telling doctors
about the nature of coronary artery disease. Read more in depth articles about
these studies below.
(source: Steve Sternberg, USA TODAY)
November
17, 2003
Aspirin-resistance
Linked to Increased Risk for Adverse Outcomes
in Routine Stenting Procedure
Researchers found that out of 136 patients scheduled for coronary stent procedure,
nearly 20 percent were aspirin-resistant and that these patients had an increased
risk of adverse outcomes in spite of being pre-treated with both Aspirin and
Plavix.
(source: ADVANCE for Administrators of the Laboratory)
November 14, 2003
Commissioner
undergoes angioplasty to clear blockage
Massachusetts Education Commissioner David Driscoll underwent angioplasty Thursday
night to remove a blockage from a main artery in his heart, and was expected
to spend the weekend recovering at Massachusetts General Hospital.
(source: Boston Globe)
November
13, 2003
Study
of Two Cholesterol Drugs Finds One Halts Heart
Disease
More in-depth story about the advantages offered by Lipitor over Pravachol
and how Steven Nissen, MD of the Cleveland Clinic uses intravascular
ultrasound to measure the arterial plaque. However, another article
from HealthDayNews, titled "Doctors
Divided Over Cholesterol Drugs Study", reveals some disagreement
in the medical profession about the significance of the results
(source: Gina Kolata, New York Times -- free registration required
by NYT / Amanda Gardner, HealthDayNews)
November 12, 2003
Drugs
That Stop Plaque
A good round-up of the various studies and presentations made at this year's
American Heart Association meeting about pharmaceuticals and their effects
on plaque buildup in the coronary arteries, and even plaque reversal. The articles
starts with the Cleveland Clinic study that showed Lipitor superior to Pravachol
and goes on to other drugs.
(source: Matthew Herper, Forbes.com)
November
12, 2003
Emergency
Surgery Critical After Failed Angioplasty
An estimated one in four patients are at increased risk of death or harm if
emergency heart surgery is delayed after they have failed angioplasty. A Canadian
study looked at over 6,000 angioplasties performed, 45 of which required emergency
bypass surgery to fix a problem, a rate of 0.7% -- of these 11 patients would
have been harmed if surgery had been delayed.
(source: HealthDayNews)
November
12, 2003
Antiplatelet
Drug Found to Reduce Risk of Recurrent Heart
Attacks and Stroke Is Extremely Cost-Effective
The antiplatelet medicine clopidogrel is not only effective in reducing the
risk of recurrent heart attack and stroke, it is also extremely cost-effective,
according to data presented today by researchers from Emory University at the
American Heart Association's Scientific Sessions.
(source: Emory Heart Center)
November
11, 2003
Drug
Proven to Benefit Heart Attack Victims Vastly
Underused
A study of the CRUSADE registry shows almost two out of three patients did
not receive a class of clot-inhibiting drugs, known as glycoprotein (GP) IIb/IIIa
inhibitors, within the first 24 hours of heart attack symptoms, despite the
fact that clinical trials that have proven that the drugs save lives. The study
also points out that other drugs, as well as emergency angioplasty, are underutilized.
(source: Duke University Medical Center)
November
11, 2003
Michigan
Angioplasty Project Cuts Problems and Deaths
A multi-hospital effort to improve angioplasty care in Michigan has increased
use of helpful drugs, cut deaths and complications, and yielded important data
that can aid angioplasty care everywhere.
(source: University of Michigan Health System)
November 11,
2003
Growth
factor grows stem cells that help heal hearts
A very small study (lead author: Chris A. Glover MD, assistant professor of
medicine at the University of Ottawa and the Ottawa Heart Institute in Ontario)
has shown positive results with a drug -- granulocyte colony stimulating factor
(G-CSF) -- that stimulates bone marrow to produce stem cells helped regenerate
damaged heart muscle
(source: American Heart Association)
November
11, 2003
Stents
open arteries, but keep costs down
A report on the CADILLAC study (Controlled Abciximab and Device Investigation
to Lower Late Angioplasty Complications) appearing in today's Circulation
Rapid Access, shows that stents are not only more effective at keeping
arteries open, but also cost-effective as well. More in the study also speaks
to the role of abciximab in catheter interventions and the results as to whether
it is cost-effective were not as straight-forward as the balloon angioplasty/stent
comparison.
(source: American Heart Association)
November
10, 2003
Five-Year
Data Presented at AHA Demonstrates Significant
Patient Benefits of CardioGenesis TMR Over Drug
Therapy
The study results showed that patients randomized to Holmium:YAG TMR had a
significantly improved survival rate, 65 percent at five years, than those
randomized to maximum medical management, 52 percent. The overwhelming majority
of patients treated with TMR (88 percent) continued to experience significant
improvement in angina pain five years after their original TMR treatment. The
conclusions of this study differ from those in a recent
Journal of the ACC, also reported in the New York Times.
(source: CardioGenesis Corporation)
November
10, 2003
Heal
thyself: Patients' bone marrow cells restore
failing hearts
Follow-up from a study by Bodo E. Strauer, M.D., professor of medicine at Heinrich
Heine University in Düsseldorf, Germany, patients who received stem cell
therapy from their own bone marrow showed improvement in heart function. The
stem cells were delivered via catheter during balloon angioplasty and stenting. Read
another article about this study from Reuters.
(source: American Heart Association / Reuters)
November
9, 2003
U-M
study reveals major differences between women
and men in cardiovascular disease traits and
treatment
A poster presentation from the current American Heart Association annual meeting
discusses the GRACE study (Global Registry of Acute Coronary Events) and shows
that coronary artery disease (CAD) manifests itself somewhat differently in
men and women which may account for the fact that CAD in women tends to be
treated less aggressively. Sujoya Dey, M.D., one of the study's authors, recommends
to women, “Believe yourself and your symptoms, and bring them to the
attention of your physician to figure out how to help you. Don’t be afraid
to ask what else they could be doing for you.” (For help on communicating
with your doctor, read the article "You
and Your Physician" in our PatientCenter.)
(source: University of Michigan Cardiovascular Center)
November
9, 2003
CREST
study finds cilostazol reduces restenosis by
almost 40 percent
A new and highly effective weapon in the war on heart disease could be on the
horizon, according to results of the "Cilostazol for RESTenosis" (CREST)
study presented today at the American Heart Association's Scientific Sessions.
The drug therapy consists of two pills a day and, in the words of John S. Douglas
Jr., MD, professor of medicine and Director of Interventional Cardiology at
Emory University, "...showed that this beneficial effect occurred in patients
with diabetes and small blood vessels, two important subgroups that are inherently
more difficult to treat."
(source: Emory Heart Center )
November
9, 2003
One-Third
of Heart Failure Patients Don't Receive Life-Saving Therapies
The ADHERE study (Acute Decompensated Heart failurE national REgistry) presented
at the AHA's Scientific Sessions 2003, concludes that a third of heart failure
patients who are ideal candidates for ACE-inhibitors are not given prescriptions
for them, almost three-quarters are not given discharge instructions (about
follow-up appointments, medications, etc.) and 69% are not counseled on how
to stop smoking.
(source: American Heart Association)
November
6, 2003
Heart
Laser Treatment Used Mostly on Patients Who Don't Meet
the Federal Criteria
Although this article is about a surgical procedure, called TMR (TransMyocardial
Revascularization) a similar catheter-based version exists, called PMR (Percutaneous
Myocardial Revascularization) which in some cardiologists' opinion holds promise
for patients who cannot benefit from surgery or angioplasty. PMR was not approved
by the FDA in July 2001; the company that makes the laser device is hoping
to resubmit it for approval in the near future. The article reports
on the "off label" use of the surgical procedure and its increased
mortality. The abstract of the study it is based on can be found here.
(source: Gina Kolata, New York Times / Journal of the American College
of Cardiology)
November
5, 2003
Cholesterol
Study Offers Hope for a Bold Therapy
An extensive article (free registration with NY Times required) on
this new research study, being published in the Journal of the American Medical
Association. You can also read the abstract of the study, titled "Effect
of Recombinant ApoA-I Milano on Coronary Atherosclerosis in Patients With Acute
Coronary Syndromes". While the study was done on a small group,
the extremely promising results make a more extensive clinical trial a necessity.
Some have characterized the new drug as "Drano" for
the arteries.
(source: Gina Kolata, New York Times / Journal of the American Medical
Association / Toronto Star)
November 5, 2003
Synthetic
'Good' Cholesterol Helps Clear Arteries: Small
Study Indicates the Possibility That Drug Therapy
Could Reverse Heart Disease
Another article on the "hot" topic of the new cholesterol discovery
that may yield a new treatment for coronary artery disease
(source: Rob Stein, Washington Post)
November
4, 2003
Unusual
fatigue may be warning symptom of heart attack
in women
About 95% of women reported having new or different symptoms more than a month
before their heart attacks that resolved after their heart attacks. This led
them, in retrospect, to believe that these symptoms were related to the subsequent
heart attack. The most common early symptoms were: unusual fatigue — 70%;
sleep disturbance — 48%; shortness of breath — 42%; indigestion — 39%
and anxiety — 35%.
(source: American Heart Association)
November 4, 2003
Angioplasty:
it could be a lifesaver, but it’s not a
local option
A story from Gilroy, a small town in California, and their hospital's quandry
about treating heart attacks.
(source: Lori Stuenkel, Gilroy Dispatch)
November 2, 2003
Kentucky
Governor Patton Has Two Stents Implanted - Released
to Attend Football Game Same Night
Governor had elevated heart rate after exercising and was admitted for evaluation,
and then catheterization. Read
another article about him back at work.
(source: WLKY, Louisville / Cincinnati Enquirer)
October
29, 2003
Halting
Aspirin Therapy May Harm Heart Patients
A French study of 1,236 coronary patients has concluded that stopping aspiring
therapy (used for blood-thinning) even on a doctor's orders (patients are often
advised to stop taking aspirin prior to surgery or dental work) can be hazardous.
10% of the patients in the study were hospitalized within a week after stopping
aspirin.
(source: Ed Edelson, HealthdayNews)
October 26, 2003
Generous
Medicare Payments Spur Specialty Hospital Boom
An article from the Business Section of today's NY Times examines the economics
of Medicare and the building of new "heart centers". (Note: free
registration with NY Times is required.)
(source: Reed Abelson, New York Times)
October 24, 2003
More
Than One Stent at a Time Safe After All
Simultaneous stenting of coronary, carotid and several other arteries with
significant atherosclerosis may save money and help patients avoid having to
undergo multiple stenting procedures, according to an Austrian study in the
November issue of "Catheterization and Cardiovascular Interventions."
(source: HealthDayNews)
October
23, 2003
Blood
test can warn of heart attack
A new blood test, identified
by researchers at the Cleveland Clinic, has been found to be highly
predictive of heart attacks in patient who have chest pain. In the words of
Richard Stein of the Weill Cornell School of Medicine in New York, "It's
the first simple blood test that will allow us to take a patient who comes
into the hospital with chest pain and say whether he's in the early stages
of a heart attack or if he's at risk of having a heart attack in 30 to 60 days." You
can also read the abstract of the study, "Prognostic
Value of Myeloperoxidase in Patients with Chest Pain" in the
New England Hournal of Medicine.
(source: Steve Sternberg, USA Today / Cleveland Clinic / New England
Journal of Medicine)
October 21, 2003
Volcano
Therapeutics, Inc. Announces the Demonstration
of its Virtual Histology™ Intravascular
Ultrasound (IVUS) Technology During Live Case
Demonstrations at CCT 2003 on October 21, 22,
and 23
Company press release about its latest use of its device during live case demonstrations
in Kobe, Japan.
(source: Volcano Therapeutics, Inc.)
October 20, 2003
Study
tests stents vs. surgery for clogged carotids
Local perspective on the CREST (Carotid Revascularization: Endarterectomy vs.
Stenting Trial) study currently being done at over 60 hospital centers to determine
the effectiveness and safety of carotid stenting.
(source: Kristi L. Nelson)
October 19, 2003
Maryland
hospital debate grows over greater access to
angioplasty; Health panel to decide which can
offer procedure
A good article on the debate over performing angioplasty without surgical backup.
(source: M. William Salganik, The Baltimore Sun)
October 14, 2003
Quick
fix -- Technique allows hospitals and doctors
to treat heart attacks faster
Yet another local story (appearing in the Times Daily of Northwest Alabama)
about bringing a heart attack victim not to the closest hospital, but to one
that practices emergency angioplasty.
(source: Daniel Q. Haney, Associated Press Medical Editor)
October
13, 2003
Stem
Cell Therapy Helps Heal Damaged Heart -- Healthy
tissue created after heart attack
Discusses the important work being done by Dr. Andreas M. Zeiher, chairman
of University of Frankfurt's department of medicine in the field of stem cell
treatment.
(source: Ed Edelson, HealthDayNews)
October 13,
2003
Strong
Medicine: The Uncut Version
Interventional cardiologists versus surgeons -- the rise of low-invasion techniques—and
the doctors who specialize in them—has made the competition for surgical
patients, well, cutthroat.
(source: Joanna Kaufman, New York Magazine)
October
13, 2003
Heart
attack strategy changes
Local perspective from Everett, Washington on how the treatment of heart attacks
has changed in terms of transporting patients to hospitals that perform angioplasty,
instead of the nearest one.
(source: Sharon Salyer , Daily Herald)
October 12, 2003
Angioplasty:
a look at local efforts
Fewer and fewer patients in the area are likely to receive thrombolytic therapy
-- the use of clot-dissolving drugs -- in the case of a heart attack.
(source: Brian Bardwell , Cleveland Morning Journal )
October 11, 2003
Both
Topeka hospitals do angioplasty procedure --
Method saves lives
Another local story about use of angioplasty in the treatment of heart attack
and the hospitals where it is offered.
(source: Morgan Chilson and Tim Hrenchir, Topeka Capital-Journal)
October 10, 2003
The
best treatment most heart victims aren't getting;
Drugs more likely to be used over angioplasty
procedure
A very interesting article on why in many places heart attack patients are
not being offered angioplasty. In the article, Dr. Joseph Carrozza, chief of
interventional cardiology at Boston's Beth Israel Deaconess Medical Center,
states: "There are a lot of strong community hospitals that aren't offering
primary angioplasty and would line up all their politicians against an effort
to have heart attacks taken away from their hospitals."
(source: CNN)
October 10,
2003
CardioGenesis
Announces Update on FDA Review of Percutaneous
Myocardial Revascularization (PMR) System
Turned down for FDA approval in 2001, the company (originally Eclipse Surgical)
is hoping for another chance at approving its catheter-based version of TMR
(TransMyocardial Revascularization).
(source: CardioGenesis Corporation)
October
8, 2003
Guidant
Initiates Voluntary Recall of 3.0 mm-Diameter MULTI-LINK
VISION Coronary Stent System
The company has initiated a
voluntary recall of a limited number of 3.0mm stents
that did not meet manufacturing specifications.
(source: Guidant Corporation)
October 8, 2003
SPOTLIGHT
-- Eric Williams: Designer with heart; Business
helps save lives with plastic tubes
Interesting human interest article about a stent designer in the SF Bay Area,
one of the founders of Advanced
Stent Technologies.
(source: Vanessa Hua, San Francisco Chronicle)
October 7, 2003
Percutaneous
coronary intervention versus fibrinolytic therapy
in acute myocardial infarction: is timing (almost)
everything?
This abstract of a study in the October 1 JACC finds that the benefits of angioplasty
in treatment of heart attack is greatest within the first hour. Full text of
the article is available to JACC subscribers, or you can read an article about
the same study from Reuters
Health.
(source: Journal of the American College of Cardiology / Reuters
Health)
October 5, 2003
Angioplasty
stops heart attacks; treatment works better than
drugs
A local view from Brevard County in Florida of the use of angioplasty in the
treatment of heart attacks (for more information, read our feature
topic on this subject)..
(source: Florida Today)
October 5, 2003
Angioplasty
is better treatment for heart attacks
A good update on the current state of angioplasty in the treatment of acute
MI (heart attack).
(source: Fort Worth Star-Telegram)
October 4, 2003
McBride
Undergoes Angioplasty
Former gubernatorial candidate Bill McBride, who lost to Gov. Jeb Bush in November's
election, underwent an angioplasty to open a closed coronary artery that caused
him to collapse this week, his family said in a statement Friday.
(source: Tampa Tribune)
October 3, 2003
Angioplasty
Trumps Clot Drugs for Heart Attack Patients --
But only if additional time delay is less than
an hour
Another overview of the role of angioplasty in treatment of heart attack.
(source: Amanda Gardner, HealthDay News)
October 2,
2003
FDA
Advisory Panel Recommends Non-Approval of Spectranetics
Laser Technology To Treat Critical Limb Ischemia
By a vote of 9-1, the panel recommended non-approval of Spectranetics laser
angioplasty device for use in the legs. The company states that it will continue
to pursue FDA approval. Its Excimer Laser Catheter has been approved since
1993 for use in the heart.
(source: Spectranetics Corporation)
October
1, 2003
Seven-year
outcome in the RITA-2 trial: coronary angioplasty versus
medical therapy
The results of this study comparing angioplasty to medical (drug) treatment
shows no significant difference in the two therapies with regard to risk of
death or repeat heart attack (in patients considered suitable for either therapy)
-- however symptoms of angina are controlled better by angioplasty.
(source: Journal of the American College of Cardiology)
October 1, 2003
Effect
of successful late reperfusion by primary coronary
angioplasty on mechanical complications of acute
myocardial infarction
This Japanese study suggests benefits to patients treated with angioplasty
even if reperfusion (opening up vessels) is performed 12-24 hours after onset
of heart attack.
(source: American Journal of Cardiology)
October 1, 2003
Evaluation
of Prolonged Antithrombotic Pretreatment ("Cooling-Off" Strategy)
Before Intervention in Patients With Unstable
Coronary Syndromes
Conclusion of this study is that delaying interventional therapy (angioplasty)
by "pretreating" heart attack patients with clot-busting drugs does
not improve outcomes and that the goal should be early revascularization in
the cath lab.
(source: Current Journal Review, American College of Cardiology)
October 1, 2003
Time
essential for angioplasty U-M study says procedure
still preferable to clot-busting drugs but must
be done quickly
Adding to the controversy over how best to treat heart attacks, this article
reports on a study by the University of Michigan that angioplasty needs to
be done within an hour to have an effect more beneficial than clot-busting
drugs.
(source: Jo Mathis, Ann Arbor News)
September
26, 2003
Heart
Disease is the Most Serious Health Threat for
Women Globally
WHO
publishes results of largest-ever global collaboration
on heart disease, highlighting risk for women
Sunday, September 28 is "World Heart Day“ -- these two press releases
are about the impact of cardiovascular disease on women worldwide. The world
Heart Foundation states that 18 times more women die from heart disease and
stroke than from breast cancer. And Dr Catherine Le Galès-Camus, WHO
Assistant Director-General, Noncommunicable Diseases and Mental Health says, "Although
most women fear cancer, particularly breast cancer, they do not make the same
efforts to safeguard themselves from heart disease, which is eminently preventable.
We must strive to make women aware that to keep their hearts healthy, they
need to eat smart, kick smoking and move for health.”
(source: World Health Foundation (WHO) / World Heart Foundation)
September 25, 2003
Boston
Scientific Manufacturing Facility Named Best
Plant By Industry Week Magazine
Commenting on being named one of the 10 best plants in North America by Industry
Week magazine, President and CEO Jim Tobin stated, "This is national recognition
for our ongoing efforts to create a world- class manufacturing environment
at Boston Scientific.... The award is further evidence that we are making solid
progress toward our goal of increasing productivity and enhancing innovation." Click
here to read the actual report in Industry Week.
(source: Boston Scientific Corporation / Industry Week)
September 19, 2003
Abbott
Announces 30-Day Results of Clinical Trial For
Carotid Artery Stent and Filter System
The company announced the preliminary results from its SECuRITY trial, a registry
of high-risk patients utilizing the MedNova EmboShield® bare-wire filter
and MedNova Xact® self-expanding carotid stent system. The trial was designed
to evaluate the safety and efficacy of the filter-stent combination as a minimally
invasive option for treating carotid artery disease in patients considered
at high risk for surgery.
(source: Abbott Laboratories)
September 18, 2003
Guidant
Announces Additional Findings of Key Study In
Emerging Field of Heart Attack Prevention
This company press release reports on a new imaging technology, optical coherence
tomography (OCT), which was used to examine highly detailed images of complex
coronary lesions in patients with coronary artery disease.vulnerable. The study
showed correlation between lipid-rich plaques and heart attacks -- in short:
not all plaques are created equal -- some are more dangerous than others.
(source: Guidant Corporation)
September 16, 2003
Bypass
surgery may relieve chest pain better than angioplasty
plus stent
Data from the Stent or Surgery trial, the first in which patients were randomized
for either bypass surgery or angioplasty to study longer term effects on relief
of angina, shows that while both procedures were highly successful, surprisingly
the surgically treated patients showed 2 or 3 points greater improvement in
chest pain relief and quality of life. One of the study's authors states, “Since
there were substantial improvements in chest pain and quality of life in both
groups, the findings should be used more as a guide to treating patients with
angina rather than viewed as an endorsement of one procedure over another.”
(source: American Heart Association)
August
31, 2003
Study
indicates blood pressure drug should be considered
even for patients with mild coronary disease
At the annual meeting of the European Society of Cardiology (ESC) the EUROPA
study was presented, showing that coronary heart disease patients who had been
given the ACE inhibitor perindopril fared at least 20% better than the control
group. The study recommends that this therapy be widely considered for all
patients, even those with only moderate risk.
(source: Emma Ross, AP Medical Writer)
August 27, 2003
Boston
Scientific Announces FDA Approval of the EPT-1000
XP™ Cardiac Ablation System for the Treatment
of Atrial Flutter
It has been estimated that there are more than 200,000 new patients diagnosed
with atrial flutter each year in the United States. Gregory Feld, MD of the
University of California San Diego Medical Center, principal Investigator of
the clinical trial involving the device, stated, "The results of this
multi-center study show shorter procedure times with fewer ablations and a
chronic success rate for atrial flutter in excess of 96 percent."
(source: Boston Scientific Corporation)
August 25, 2003
Black
Women Get Worse Heart Care, Study Finds
According to a study, published in the American Heart Association journal Circulation,
black women may have a higher risk of heart disease than white women, but they
get worse care. Dr. Michael Shlipak, who directed the study, said black women
need to be aware that heart disease is more likely to kill them than anything
else and take charge when they see a doctor. "We don't really know if
the undertreatment of black women is being driven by physicians or patients.
But, the more women are empowered to participate in their cardiac care, the
better off they will be," he said.
(source: Reuters)
August
21, 2003
Angioplasties
Are Worth the Wait
Results of the DANAMI-2 study, published in today's NEJM (read
abstract here), concludes that transferring patients who are experiencing
myocardial infarction with ST-segment elevation (heart attack) to a hospital
equipped to perform angioplasty is superior to on-site thrombolytic treatment,
provided the transfer can occur within two hours. The risk of death, repeat
heart attack or stroke was reduced by 60%. This study strongly bolsters earlier
findings that heart attack patients should be brought to an interventional
center, NOT to the nearest hospital.
(source: CBS News / New England Journal of Medicine)
August
19, 2003
Heart
Risk Factors Are Real -- Studies Confirm
Contrary to much that has been published, citing the inevitablitiy of heart
attacks due to genetics, etc., two studies published in tomorrow's Journal
of the American Medical Association state that most heart events occur
in individuals who have had exposure to one or more conventional risk factors,
several of which are under the control of the patients. The major implication
of these findings is that patients can do far more in helping prevent heart
attacks than previously thought. You can access the full-text articles for
a fee from JAMA entitled Major
Risk Factors as Antecedents of Fatal and Nonfatal Coronary Heart Disease Events and Prevalence
of Conventional Risk Factors in Patients With Coronary Heart Disease.
(source: ABCNews / Journal of the American Medical Association)
August
14, 2003
Boston
Scientific Launches Next Generation Intravascular
Ultrasound Imaging System
Boston Scientific, which states it is the "worldwide market leader in
IVUS technology", announces the launch of its next generation intravascular
ultrasound (IVUS) imaging system, the Galaxy®2 System. These systems consist
of consoles and catheters, which together provide cross-sectional and longitudinal
ultrasound images of the inside of an artery or the heart. For background information
on the field of intravascular ultrasound, read
our article on IVUS.
(source: Boston Scientific Corporation)
August 12, 2003
Boston
Scientific Announces FDA Clearance for Guglielmi
Detachable Coils (GDC®) for Expanded Treatment
of Brain Aneurysms
While not a coronary treatment, this device exemplifies the revolution in medicine
brought about by catheter-based technologies that started with PTCA over 25
years ago.
(source: Boston Scientific Corporation)
August
11, 2003
Cells
'reverse heart attack damage'
The body's master cells can repair the damage caused by a heart attack, suggests
a study by Dr Victor Dzau and colleagues at Brigham & Women's Hospital
in Boston. Tests on rats have shown that stem cells can restore up to 90% of
the heart's ability to pump blood around the body, which is often reduced following
an attack.
(source: BBC News)
August
7, 2003
Studies
Sow Doubt Over Hormone Therapy Benefits
Two new studies about the effects on coronary heart disease of hormone replacement
therapy for postmenopausal women were published in today's New England Journal
of Medicine. Hormone therapy, originally indicated for relief of the symptoms
of menopause, was touted for years as a protection for heart disease in women.
Studies published earlier this year disputed this. Now these studies agree:
one study -- abstract
here -- stated there was no benefit in stopping the advancement
of coronary heart disease, while the second -- abstract
here -- actually showed a significant increased risk of heart
attack, especially in the first year. Another
article from ABC News points out that, while the actual risks
are not tremendous, these factors should be taken into account by women and
prescribing physicians. Finally, an article
in the Washington Post discusses how a number of women want
to resume hormone therapy and what members of the medical profession are recommending.
(source: Reuters / New England Journal of Medicine / ABC News /
Washington Post)
August 6,
2003
Treatment
After Heart Attack Should Be Speedy
A study headed by Dr. David A. Alter, from the University of Toronto, published
in the current Journal of the American College of Cardiology -- read
abstract here -- states that heart attack patients admitted
to hospitals that perform "invasive" treatments (angioplasty and
bypass surgery) do better than those at "non-invasive" hospitals.
(source: Journal of the American College of Cardiology / Reuters
Health)
August 5,
2003
New
Guidelines for Echocardiography
Updated guidelines on echocardiography include new recommendations for its
use during stress or exercise testing, as well as in patients with heart failure
or those who are critically ill. Read
a PDF file of the Guidelines here.
(source: HealthDay / American College of Cardiology - American Heart
Association Task Force)
August 5,
2003
Anger
trigger to heart disease found?
A study in the journal Psychosomatic Medicine by Edward C. Suarez,
PhD of Duke University concludes that anger and hostility may trigger the production
of blood protein interleukin 6 (or IL-6) involved in inflammation -- for the
first time making a physiological link between the emotional state and heart
disease. Also read
the abstract.
(source: Australian Broadcasting Corporation Science News / Psychosomatic
Medicine)
August
1, 2003
What
Do Patients Want and Do They Get It?
A report on a study from the Archives of Internal Medicine shows that patients
can have a significant effect on what their doctor does -- patients who requested
a referral to a specialist were four times more likely to receive the referral
than those who did not make the request. Also read
a report on the study from Reuters Health,
(source: Archives of Internal Medicine / Reuters Health / )
August
1, 2003
Physical
Activity May Slow Atherosclerosis
This article, reporting on findings published in the July issue of the American
Journal of Medicine, states "Leisure time physical activity slows the
build-up of plaque in the arteries (atherosclerosis), and the more vigorous
the activity, the greater the benefit."
(source: Reuters Health)
July, 2003
Internet
Access and Empowerment: A Community-based Health
Initiative
An abstract in the July issue of the Journal of General Internal Medicine about
a research project that shows that access to online health information increased
empowerment, confidence in technology and control over health-related decisions
in a low-income neighborhood in Chicago.
(source: Journal of General Internal Medicine)
July 30,
2003
Boston
Scientific and Corautus Genetics Enter Gene Therapy
Alliance
The companies have entered into a strategic alliance to develop and commercialize
a gene therapy technology to treat cardiovascular disease, focusing initially
on patients with severe ischemic heart disease who have been unresponsive to
conventional therapies. For more background on this emerging field,
see our article on "Angiogenesis".
(source: Boston Scientific Corporation)
July 30, 2003
Medtronic
Announces U.S Availability of the NC Stormer® Balloon
Catheter
The company press release states, "A non-compliant balloon, such as the
NC Stormer balloon, is used primarily for treating challenging coronary lesions,
as well as to reopen partially closed stents or further expand implanted stents—either
during the initial interventional procedure or during a subsequent intervention."
(source: Medtronic, Inc.)
July 29, 2003
Statins
help heart failure patients without high cholesterol
“This is the first prospective study to show that statins have beneficial
effects in heart failure in the absence of coronary artery disease or high blood
cholesterol,” says senior author James K. Liao, M.D., director of vascular
medicine research at Brigham & Women’s Hospital and associate professor
of medicine at Harvard Medical School, Boston, Mass. “This was a surprising
finding in that the benefits occur after only 14 weeks of treatment and with
a very low dose of the drug.”
(source: American Heart Association)
July 25, 2003
Virtual
medicine: Students train on simulation mannequin
Students at UC Davis Medical Center are using "Simantha", a new highly-detailed
medical procedure simulator, to learn the fine points of catheter-based interventions
without risk to a patient.
(source: Alison C. Burggren, Sacramento Bee)
July 23, 2003
Filter-Based
Catheter Equal to Balloon Occlusion and Aspiration
System for Distal Protection During PCI of Saphenous
Vein Grafts
A report by Gregg W. Stone MD of the Cardiovascular Research Foundation and
Lenox Hill Heart and Vascular Institute (NYC) and the FilterWire EX Randomized
Evaluation (FIRE) team shows that filter-based catheters, which offer the inherent
advantages of maintained perfusion and ease of use, are as effective as balloon
occlusion / aspiration methods.
(source: Circulation)
July 23,
2003
Diet
May Cut Cholesterol As Much As Drugs Do
Researchers in Canada have published a study in today's Journal of the
American Medical Association (read
abstract) that shows a vegetarian diet high in soluble fibre
and low in saturated fats can lower "bad" cholesterol as much as
currently used pharmaceuticals.
(source: Scientific American / Journal of the American Medical Association)
July 22, 2003
Early
heart disease in parents linked to thicker artery
walls in offspring
If your parents had coronary heart disease before age 60, the walls of your
neck arteries are more likely to be thicker, putting you at higher risk of
heart disease, too, researchers report in today’s rapid access issue
of Circulation: Journal of the American Heart Association.
(source: American Heart Association)
July 18, 2003
Diadexus
Receives FDA Marketing Clearance for PLAC™ Test
"The PLAC™ test is an important
new tool which physicians may use to more accurately
predict who is at risk for heart disease," said
Christie Ballantyne, MD, director of the Center
for Cardiovascular Disease Prevention at Baylor
College of Medicine and the Methodist DeBakey
Heart Center in Houston. "Somewhere between
one-third and one-half of heart attacks occur
in people considered to have normal LDL cholesterol.
This test enables us to better determine who
is at risk for CHD before an adverse event occurs
(source: diaDexus, Inc.)
July 16, 2003
Guidant
Receives U.S. Approval for First Cobalt Chromium
Coronary Stent System
The use of the cobalt chromium alloy allows for a thinner strut design and
a lower profile, which enables physicians to access challenging coronary blockages.
Guidant plans to use its cobalt chromium stent technology in future programs
including drug eluting stents and vulnerable plaque therapies.
(source: Guidant Corporation)
July 15,
2003
Age-related
Stem Cell Loss Prevents Artery Repair And Leads
To Atherosclerosis
Scientists at Duke University Medical Center have discovered that a major problem
with aging is an unexpected failure of the bone marrow to produce progenitor
cells that are needed to repair and rejuvenate arteries exposed to such environmental
risks as smoking or caloric abuse. The researchers demonstrated that an age-related
loss of particular stem cells that continually repair blood vessel damage is
critical to determining the onset and progression of atherosclerosis, which
causes arteries to clog and become less elastic.
(source: Science Daily)
July 8, 2003
On
the go: Clot buster-blood thinner ambulance combo
may jump-start heart attack treatment
Combining a clot buster with a form of the blood thinner heparin can be safely
initiated for heart attack victims enroute to the hospital – an approach
that reduces the time to treatment and could significantly improve survival,
according to a rapid track study in today’s Circulation: Journal
of the American Heart Association.
(source: American Heart Association)
July 8, 2003
American
Heart Association outlines 'chilling' plan to
prevent brain damage after cardiac arrest
Lowering the body temperature of a person who has been resuscitated after suffering
cardiac arrest can help prevent brain damage, according to an international
advisory statement published today in Circulation: Journal of the American
Heart Association.
(source: American Heart Association)
June 30, 2003
Hospitals
get OK to offer lucrative angioplasty
The Maryland Health Care Commission on June 19 approved a plan to allow hospitals
that do not offer open-heart surgery services the right to perform elective
angioplasties, provided the hospitals meet criteria established by the commission.
The move is a small but important step for the "have-not" hospitals
that have long been locked out of the lucrative cardiac surgery market.
(source: Baltimore Business Journal)
June 19, 2003
Rosiglitazone
Reduces Development of Heart Stent Blockage
Reporting from the Annual Meeting of the American Diabetes Association: the
anti-inflammatory drug, rosiglitazone (Avandia), not only lowers blood sugar
levels, but prevents or dramatically reduces the development of new blockages
(restenosis) in heart stents, say researchers.
(source: Stanford University)
June 13, 2003
Guidant
pleads guilty to defect cover-ups
The company settled criminal and civil claims for $92.4 million, the largest
ever fine paid by a medical device group for failure to make reports required
by law with regulators. The problems were with Guidant's abdominal aortic aneurysm
repair device, which was taken off the market in 2001.
(source: Christopher Bowe, Financial Times)
June 10, 2003
Bleed-detecting
MRI may identify dangerous plaque
Not all plaque is equal, and complicated plaque that involves intra-plaque
bleeding is at high risk for stroke or heart attack. Two studies show how Magnetic
Resonance Imaging (MRI) can help identify these plaques.
(source: American Heart Association)
June 10, 2003
Boston
Scientific Announces FDA and CE Mark Approvals
for Cutting Balloon Ultra2 Dilatation Device
The Cutting Balloon Ultra2 device represents the next-generation of the Company's
Cutting Balloon product. It features tiny, longitudinally mounted atherotomes
(microsurgical blades) that help reduce resistance of a lesion to expansion.
The atherotomes create incisions that relieve stress in the artery as the balloon
inflates, reducing the force necessary to expand the vessel.
(source: Boston Scientific Corporation)
June 10, 2003
Disease
of the Peripheral Arteries Can Be a Crucial Warning
Signal
The authors states, "The disease is an early warning sign that cries out
for help. Yet two-thirds of those afflicted do not know they have it because
they have no symptoms. Doctors often fail to diagnose it even in those with
symptoms, though there is a simple, noninvasive test for it. And even many
who know they have it are not receiving potentially lifesaving treatment."
(source: Jane E, Brody, New York Times (registration required)
June 10, 2003
Guidant
Begins Second Clinical Trial to Develop Minimally
Invasive Treatment for Carotid Artery Disease
The company announced the enrollment of the first patient in its second clinical
trial designed to evaluate carotid artery stenting as a minimally invasive
alternative for patients who are at high risk for stroke and are ineligible
for current surgical options or at high surgical-risk. The clinical trial,
called ARCHeR RX, (ACCULINK for Revascularization of Carotids in High-Risk
Patients), is a prospective, non-randomized, multi-center, single-arm study
that will enroll 145 patients in the United States, Europe and South America.
(source: Guidant Corporation)
June 10, 2003
Off-pump
bypass results in fewer complications
Since most patients in midlife now have angioplasty instead of bypass, the
surgical population is increasingly older. Off-pump bypass surgery has been
developed to reduce the negative effects of surgery. Hawaiian researchers have
found a 30-fold reduction in the micro-embolic burden tiny debris that
break off in surgery which can travel to the brain and result in neurological
complications.
(source: American Heart Association)
June 9, 2003
Boston
Scientific Announces FDA Approval For FilterWire
EX Embolic Protection System
The FilterWire EX system is a low-profile embolic filter mounted on a guidewire
that is designed to reduce complications during balloon angioplasty and stenting
procedures in saphenous vein grafts (SVG). It captures embolic material that
becomes dislodged during cardiovascular interventions. The debris captured
by the filter would otherwise travel into the microvasculature where it could
cause a heart attack. The FilterWire EX is the first filter-based system approved
for SVG treatment in the U.S.
(source: Boston Scientific Corporation)
May 9,
2003
Stanford
University School of Medicine Conducting Online
Trial of Disease Management Program for Patients
(source: Stanford Patient Education Research Center
April 27, 2003
Who
Will Pay for New J&J Device?
Article states:"Now that Johnson & Johnson's groundbreaking device
for clogged arteries is officially on the U.S. market, the dance begins over
who will pick up the expected $3,200 tab for the product."
(source: Kim Dixon, Reuters)
April 25, 2003
Boston
Scientific Close On J&J's Heels With New
Stent
More from the business press about the implications of the FDA approval of
J&J's Cypher stent on Thursday for J&J and its competitors.
(source: Zina Moukheiber, Forbes.com)
April 25, 2003
A
Clog Clears for J&J
"The FDA finally approves its advanced drug-coated stent for keeping arteries
open. The bad news: Rivals are on the way."
(source: Amy Barrett, BusinessWeek Online)
April 24, 2003
Former
Truck Driver To Be First In US To Get Cypher
Stent
This Dow Jones article announces that sometime late Thursday, the same day
that the FDA approved Cordis/Johnson & Johnson's Cypher stent, a patient
of Dr. Martin Leon of Lenox Hill Hospital in New York will be the first in
the U.S. to receive the stent outside of clinical trials. (You
can read an interview with Dr. Leon in our archive.)
(source: Daniel Rosenberg, Dow Jones Business News)
April
24, 2003
FDA
Approves Drug-Eluting Stent for Clogged Heart
Arteries
Today marks the long-awaited US approval of Johnson & Johnson's Cypher stent.
The FDA states: "The Food and Drug Administration today approved the first
drug-eluting stent for angioplasty procedures to open clogged coronary arteries.
The new stent slowly releases a drug, and has been shown in clinical studies
to significantly reduce the rate of re-blockage that occurs with existing stents".
Also read
this press release from the company, and an
article from Reuters.
(source: US Food & Drug Administration / Cordis Corporation
/ Debra Sherman, Reuters )
April 21, 2003
Patients
wait, risking heart attack
Some of the 40,000 U.S. patients lining up for the next big Johnson & Johnson
product are risking heart attacks while they wait, doctors said. Richard Schatz,
a Scripps Clinic cardiologist and co-inventor of the original stent, said, Weve
had a couple crash and burns, where we said lets wait it out, and then
theyve had a heart attack while they are waiting. Weve been thinking
since March that (approval) would be right around the corner. Weve been
putting off as many (procedures) as we can.
(source: Paige Orr, Bloomberg News)
April 16,
2003
Cancer
Drug Improves Stent Outcomes; Taxol keeps narrowed
vessels open after angioplasty, study finds
This article summarizes the results of the Asian Paclitaxel-Eluting Stent Clinical
Trial (ASPECT), which were published in this week's New England Jounral of
Medicine. under the title, "A
Paclitaxel-Eluting Stent for the Prevention of Coronary Restenosis. " The
study used a stent manufactured by Cook. A later U.S. study with a different
Cook stent was stopped when it became clear that the trial would fail, yet
the results of this ASPECT trial are very positive, as have been other Paclitaxel
trials, such as the Boston Scientific TAXUS II. It may be the stent itself,
or the polymer coating that makes the difference.
(source: Adam Marcus, HealthScout / New England Journal of Medicine)
April
14, 2003
J&J
Still Awaits Approval of Potential Blockbuster
Stent
The Cypher stent, approved in Europe for a year now, still has not been approved
by the FDA, although it was recommended for approval by the FDA panel six months
ago.
(source: Daniel Rosenberg, Dow Jones Business News)
April 13, 2003
Decisions
elsewhere may help area hospitals
An article from Polk County, Florida, about the effect that a Rhode island
panel's recommendations regarding emergency angioplasty without surgical backup
will have on their local healthcare.
(source: Steven N. Levine, Polkonline.com)
April 12, 2003
Study
Faults Veterans Administration on Heart Care
The Agency has vowed to improve its system, but a study showed that patients
at VA hospital are half as likely to receive angioplasty or bypass surgery
as their non-VA counterparts.
(source: David Brown, Washington Post)
April 10, 2003
Governor
of Alaska Frank Murkowski has Angioplasty
Murkowski, 70, was flown from Juneau to Anchorage where doctors at Providence
Alaska Medical Center performed the procedure Wednesday night to restore normal
blood flow to the governor's heart. Murkowski had no complications during the
procedure and was in good condition Thursday. He was expected to be released
Friday morning.
(source: Mary Pemberton , Associated Press)
April 10, 2003
FDA
Panel Unanimously Approves Cook's Zenith® AAA
Endovascular Graft
A major hurdle was cleared for this device, a third-generation stent-graft
system for the endovascular treatment of abdominal aortic aneurysm (AAA). The
development of these devices branched directly from the success of the coronary
and peripheral stents developed in the 80's and 90's by Palmaz, Gianturco and
many others.
(source: Cook Inc.)
April 8, 2003
Rolling
Stones troupe member suffers a heart attack
A member of the Stones tour was diagnosed as having a heart attack. He was
rushed to Bombay Hospital in India and life-saving angioplasty was performed.
(source: Express India News Service)
April 7, 2003
Advanced
Stent Technologies, Inc. Announces Commencement
Of U.S. Pivotal Study of Its SLK-View Stent
and Delivery System to Treat Coronary Bifurcation
Lesions
The study, named "Bifurcation Optimized with the SLK-View Stent," or "BOSS," will
utilize the SLK-View stent and delivery system to provide side branch access
while treating coronary bifurcation lesions -- a type of blockage that occurs
at the "Y" where two arteries branch off, always a complicated place
in which to expand balloons or stents, since expanding a balloon in one branched
artery compresses the other artery
(source: Advanced Stent Technologies, Inc.)
April 7, 2003
Beta
Blockers Before Angioplasty For Myocardial Infarction
Has Clinical Benefit
Beta blocker use before primary angioplasty for acute myocardial infarction
appears to have a beneficial effect on short-term outcomes, say researchers.
(source: Doctor's Guide)
April 4, 2003
J&J
To Launch Trial Comparing Its Stent To Boston
Scientific's
"Stent Wars" continues head-to-head: Johnson & Johnson said this
week it plans to fund a 1,000-patient trial to demonstrate what it says is the
superiority of its Cypher drug-eluting stent over rival Boston Scientific Corp.'s
Taxus drug-eluting stent. Boston Scientific spokesman Paul Donovan said his company
welcomes J&J's new trial. "We welcome any legitimate comparison of our
drug-eluting stent technology to J&J's. We have a better stent, a better
drug and dose combination, a better polymer and a better delivery system."
(source: Daniel Rosenberg, Dow Jones Business News)
March 31, 2003
Boston
Scientific Files Suit Against J&J
Boston Scientific said it filed a lawsuit earlier this month in U.S. District
Court in Delaware charging that J&J's Cypher drug-coated stent infringes
a Boston Scientific patent.
(source: Wall Street Journal)
March 31,
2003
One-Year
SIRIUS Trial Analysis Confirms Cost-Effectiveness
of CYPHER Sirolimus-eluting Coronary Stent
In an independent economic analysis presented at the American College of Cardiology
52nd Scientific Session by Dr. David J. Cohen of the Harvard Clinical Research
Institute, the use of the CYPHER drug-eluting stent was shown to actually save
healthcare dollars, even though the stent itself is significantly more expensive
than a standard bare-metal stent. The savings were the result of the reduction
in repeat interventions.
(source: Cordis Corporation)
March 30, 2003
Boston
Scientific Announces 12-Month Follow-Up Data
From TAXUS II Clinical Trial; Low six-month MACE
and TLR rates maintained at one year
Principal investigator Professor Antonio Colombo, M.D., EMO Centro Cuoro Columbus,
Milan presented data confirming that the beneficial results seen at six months
were maintained at one year, even in the diabetic population. He stated, "The
12-month data is extremely impressive and provides additional, consistent evidence
of the safety and efficacy of paclitaxel-eluting stent technology."
(source: Boston Scientific Corporation)
March 19, 2003
Boston
Scientific bets on new stents; CFO says devices
could generate $2 bln in 2004
Speaking at the SG Cowen health-care investment conference in Boston, Lawrence
Best affirmed that his company hopes to win Food and Drug Administration clearance
for their drug-eluting stents -- tiny mesh devices that cardiologists use to
prop open clogged arteries -- late this year. Drug-coated stents represent
a "revolutionary" way of treating heart disease and could be the "largest
opportunity in medical devices ever seen," Best said.
(source: Ted Griffith, CBS.MarketWatch.com)
March 18, 2003
Boston
Scientific Announces Start of TAXUS V Clinical
Trial
In this press release, the company announces submission of second module of
PMA application for its TAXUS paclitaxel-eluting coronary stent system.
(source: Boston Scientific Corporation)
March
13, 2003
Boston
Scientific Announces TAXUS Paclitaxel-Eluting
Coronary Stent System Granted 'Expedited Review'
Status By FDA; FDA Says TAXUS Product May Represent
'Breakthrough Technology'
Boston Scientific Corporation announced today that it has received notification
from the U.S. Food and Drug Administration that its TAXUS paclitaxel-eluting
coronary stent system has been granted "expedited review" status. Granting
of expedited review status means that the application is designated to receive
priority review before other pending applications.
(source: Boston Scientific Corporation)
March 11, 2003
Boston
Scientific and Osiris Therapeutics Announce Stem
Cell Alliance
This company press release announces a strategic alliance to deveop catheter-based
application of mesenchymal stem cell (MSC) technology to help patients who
have suffered a heart attack.
(source: Boston Scientific Corporation)
February 26, 2003
Bill
Aims to Speed Medicare Device Coverage
U.S. lawmakers on Wednesday unveiled legislation designed to reduce the time
it takes for Medicare to cover new medical devices. According to a June 2002
report on the agency's Web site, the average time for making a national coverage
decision for a new technology was between 65 and 96 days in fiscal year 2001.
Some complicated cases took longer. It took another 156 days on average after
a coverage decision was made to implement the policy, the report said. Medicare
won praise for announcing in July 2002 it would cover drug-coated stents, a
breakthrough for treating clogged arteries, after they hit the market. The
first is expected to be approved for sale in the coming weeks.
(source: Lisa Richwine, Reuters)
February
25, 2003
Boston
Scientific Announces Submission of First Module
of PMA Application For Its TAXUS Paclitaxel-Eluting
Coronary Stent System
This company press release announces the beginning of the FDA approval process
for Boston Scientific's drug-eluting stent system. The company plans to complete
its PMA application in June with a module which will include data from its
TAXUS IV clinical trial, the large pivotal trial supporting U.S. commercialization.
Results of the TAXUS IV clinical trial will be announced in September at the
Transcatheter Cardiovascular Therapeutics symposium in Washington.
(source: Boston Scientific Corporation)
February
18, 2003
Boston
Scientific Announces European Launch of its TAXUS Paclitaxel-Eluting
Stent System
In a company press release Jim Tobin, President and Chief Executive Officer,
states: "Several years worth of consistent results across a number of
clinical trials have demonstrated that polymer-based delivery of paclitaxel
is a safe and effective therapy for a broad spectrum of patients, including
those with complex lesions. We are greatly encouraged by data that have reported
very low restenosis rates and significant improvements for diabetic patients,
and we are particularly encouraged by a lack of edge effect.
(source: Boston Scientific Corporation)
January 23, 2003
St.
Jude Medical Announces FDA Approval of New Labeling
For 6F Angio-Seal STS Platform
The company's press release states: " The IDE study conducted by St. Jude
Medical demonstrated how the 6F Angio-Seal STS device can significantly
reduce the time to patient ambulation following diagnostic angiography procedures,
showing 35 percent of patients ambulating in less than five minutes and the
majority ambulating within 10 minutes."
(source: St. Jude Medical, Inc.)
January
21, 2003
Boston
Scientific Announces CE Mark For its TAXUS Paclitaxel-Eluting
Stent System
"This is an historic day for our company and for the treatment of coronary
artery disease," said Jim Tobin, President and Chief Executive Officer.
In the words of Dr. Antonio Colombo of Milan,"CE Mark for the TAXUS stent
will now enable large numbers of patients to benefit from the great promise of
paclitaxel-eluting stents. This is an exciting development that marks the beginning
of a new era in the treatment of coronary artery disease."
(source: Boston Scientific Corporation)
January
20, 2003
Women
Seen Undertreated for Heart Disease
The study, in Tuesday's Annals of Internal Medicine (read
the abstract) involved 2,763 postmenopausal women with heart disease.
All had suffered heart attacks or chest pain caused by blocked arteries, or
had undergone bypass surgery or angioplasty. Researchers found that beta blockers,
cholesterol-lowering drugs, and even aspirin were underused by this patient
population.
(source: Michael Rubinkam, Associated Press Writer)
January 19,
2003
Gains
on Heart Disease Leave More Survivors, and Questions
A front page article on this Sunday's New York Times about the revolution in
the treatments for heart disease that have occurred over the past three decades.
(source: Gina Kolata, New York Times -- free abstract; full article
available for purchase)
January 16, 2003
Boston
Scientific Completes Enrollment of TAXUS VI Clinical
Trial
The company announces the latest in a series of trials (which are summarized
in the article) for its drug-eluting stent system. TAXUS VI is an international
trial studying 448 patients with complex coronary artery disease at 44 sites.
It is designed to establish the safety and efficacy of the moderate-release
formulation in the treatment of longer lesions (greater than or equal to 18
mm in length).
(source: Boston Scientific Corporation)
January 14, 2003
Boston
Scientific Announces Suit By Johnson & Johnson
A new engagement in the "Stent Wars" -- Cordis Corporation, a subsidiary
of Johnson & Johnson, has filed a suit alleging that Boston Scientific
stents, including the Express2 stent, willfully infringe a patent owned
by Cordis.
(source: Boston Scientific Corporation)
January 7,
2003
Medtronic
Announces Start of ENDEAVOR Drug-Eluting Stent
Trial
The ENDEAVOR feasibility study will evaluate the safety and efficacy of Medtronic's
drug-eluting stent for the treatment of single de novo lesions in native coronary
arteries with a diameter of 3.0 mm to 3.5 mm. The new stent uses a drug, ABT-578
-- designed to inhibit smooth muscle cell proliferation, and a phosphorylcholine
coating technology -- both licensed from Abbott.
(source: Medtronic, Inc.)
January
3, 2003
Stem
Cells Offer Hope to Heart Attack Victims
Professor Gustav Steinhoff and colleagues from the University of Rostock, Germany,
injected stem cells into six patients' hearts and found five had strikingly
improved blood flow, suggesting the cells may have generated growth in damaged
areas. The study was the subject of a research
letter in this week's issue of The Lancet (Lancet requires free
registration to read abstract summaries).
(source: Reuters / The Lancet)
January 3, 2003
Johnson & Johnson's
New Stent May Dominate Angioplasties
Major story on coated stents in the New York Times (NYT registration required
-- it's free) which needs to be slightly modified by the yesterday's developments
concerning Guidant. This follows a recent front-page story about Johnson & Johnson
in the Wall Street Journal (sorry -- available to WSJ subscribers only). Currently,
in the United States, coated stents from two companies (Johnson & Johnson
and Boston Scientific) are in line for FDA approval. Read more about these
new devices in our special section on "Drug-Eluting
Stents".
(source: Reed Abelson, New York Times -- free abstract; full article
available for purchase)
January
3, 2003
Guidant
Back to Square One in Stents
Guidant announced late Thursday that its key Deliver coated stent study wouldn't
meet its primary goals and as a result, the company's deal to acquire Cook
Group Inc. has fallen apart. The data from Deliver effectively end Guidant's
coated stent program with the paclitaxel drug. The company is also working
on a stent coated with everolimus, but that product won't be available until
2005 at the earliest. Also read Guidant's
press release.
(source: Susan Nadeau, Reuters / Guidant Corporation) |