The following archived links to
news, company press releases and other information sources
are provided as a service by the Angioplasty.Org, which
is not responsible for the content found on these external
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select a news archive, or our special Drug-Eluting Stent
NewsCenter, from the following menu:
December 22,
2005 Abbott
Receives FDA Approval for StarClose™ Vascular Closure
System (source: Abbott)
An early holiday present for Abbott Vascular -- the FDA approved its
StarClose vascular closure device today -- a device that's been used
successfully internationally in over 55,000 patients. Abbott Vascular,
which comprises a number of vascular products, including the former market-leader
in vascular closure devices, Perclose, is now poised to compete with
St. Jude Medical which markets Angio-Seal, the leading closure device
which utilizes a bioabsorbable suture and collagen plug to form a seal
on the artery. StarClose is quite different from the other devices currently
used, since it is a Nitinol clip which is applied on the outside of the
artery. The company claims that in this way, nothing remains inside the
artery to cause clotting or other complications. This also avoids any
allergies that patients may have to collagen (see our very
active Forum topic on vascular closure devices to read about
the many complications patients have experienced with the devices used
to date). The reason for using a vascular closure device instead of manual
compression is two-fold: one, the patient can sit up and walk much sooner;
two, the femoral artery can be closed more securely with less complications.
The first has been borne out, but currently the complication rates between
manual and device-based closure are not different, somewhere around 3%.
It will be interesting to see if Abbott's device can reduce this complication
rate.
December 12,
2005 Patients
trust docs, but often use the Internet (source: Reuters Health)
Patients in the United States are likely to first turn to the World Wide
Web to find out health information, according to a study published in
the current Archives of Internal Medicine that looked at patients looking
for information about cancer. Only about 11% said they actually consult
their physician first, but the study also showed that patients trusted
the information from their doctors more. The implications of this study
are important because as lead investigator Dr. Bradford W. Hesse pointed
out, "Ongoing attention may be needed to adjust reimbursement policies
for time spent with patients interpreting printouts, for accommodating
shifts toward informed and shared decision making, for steering consumers
to credible information sources, and for attending to the needs of those
who fall through the cracks of the digital divide...." related stories: Trust
and Sources of Health Information -- Archives
of Internal Medicine
December
11, 2005 Cook's
industry is on the move (source: Jeff Swiatek, Indianapolis Star)
A backgrounder on privately-held Cook Group, in the context of the acquisition
and merger news of the past week. The article relates how a few years
ago the company almost was bought out by Guidant, now "the" target
of acquisition. Cook is moving forward on several fronts: it currently
is enrolling patients in a trial of its drug-coated Zilver stent to see
if it provides a solution for blocked arteries in the leg. The company
also has several versions of endografts, used to repair aortic aneurysms.
December 8,
2005 Boston
Scientific Announces Worldwide Recall of Flextome Cutting
Balloon® Systems (source: Boston Scientific Corporation)
Less than 3 months after receiving FDA
approval for its Flextome cutting balloon system, and 3 days
after offering to buy Guidant, Boston Scientific has issued a worldwide
recall for the Monorail version of the device. 40,000 cutting balloons
are being recalled after the company received 8 complaints of problems
where the distal (far) end of the device separated from the delivery
catheter as it was being withdrawn. This resulted in 3 patients having
to undergo surgery. No deaths were reported.According to the Wall Street
Journal, this was the 6th time this year that the company has had to
take product off the shelves. related stories: Boston
Scientific To Recall Catheters After 8 Complaints -- Wall
Street Journal $$ Boston
Scientific recalls artery devices -- Reuters Boston
Wants Its Balloons Back -- Red Herring
December
7, 2005 Guidant
says it'll talk with Boston Sci about a deal (source: Star Tribune, Minneapolis)
It's kind of "Well, I've already been asked to the prom by someone,
but now that you've asked me too, I'll think about it". Guidant
agrees to consider Boston Scientific's bid and allow Boston to do "due
diligence", which means Boston gets to look at the books. J&J
is not happy, but feels that their lower revised bid is still in the
best interests of Guidant. related stories: For
now, J&J decides against a counteroffer to win Guidant -- Boston
Globe Guidant,
new suitor plan talks -- Jeff Swiatek,
IndyStar
December 5,
2005 Boston
Scientific Proposes to Acquire Guidant for $72 Per Share
in Cash and Stock; Transaction Valued at $25 Billion (source: Boston Scientific Corporation)
This is breaking news. In a surprise move, Boston Scientific has offered
to buy Guidant, besting Johnson & Johnson's bid by some $3 billion
J&J's bid was reduced from its original amount in response to problems
Guidant had over faulty defibrillators and the two companies agreed to
the reduced amount less than three weeks ago. Boston Scientific states
that they have financing agreements in hand. Of course, there is the
FTC -- they would need to start the review process of the merger all
over again -- there are a number of areas where Boston would need to
divest itself of products. Boston Scientific's CEO Jim Tobin said that
the regulatory issues have been reviewed and the company is prepared
to make the required divestitures, mostly the endovascular (non-cardiac)
part of the business. He believes this acquisition would be better for
Guidant employees (he calls them "good people") than J&J's
offer. The combination of companies would be the third largest medical
device company in the world and would combine Guidant's cardiac rhythm
management (CRM) business, second only to Medtronic, with Boston DES
and other interventional products. CFO Larry Best said he believes the
agreement could be finalized by year-end with shareholder votes in the
first quarter of 2006. Stay tuned. related stories: Boston
Scientific Offers $25 Billion to Buy Guidant -- Associated
Press Boston
Scientific Bids $25 Billion For Guidant, Trumping J&J -- Wall
Street Journal $$
November 29,
2005 Cook
Launches New Angioplasty Balloon Catheter With Advanced
Features (source: Cook Incorporated)
Cook is launching the Advance ATB® PTA Dilatation Catheter, a new
peripheral balloon angioplasty catheter, optimized for ease of insertion
and pullback into the sheath. The Advance balloon incorporates an increased
lumen size for faster inflation/deflation rates while still providing
sufficient rated burst pressure to dilate demanding lesions.
November 29,
2005 Hospital
gets new intravascular imaging system (source: Dallas-Fort Worth Star Telegram)
A local news story that shows how new imaging techniques like Volcano
Therapeutics' colorized intravascular ultrasound (IVUS) and 64 slice
multislice computed tomography (MSCT) are changing the way coronary artery
disease is diagnosed.
November 29,
2005 Emergency
bypass surgery on angioplasty patients drops 90 percent (source: American College of Cardiology)
The experience of Mayo Clinic is recounted in this study appearing in
the current issue of Journal of the American College of Cardiology --
the data is in, confirming what everyone has known: that stents have
radically reduced the need for emergency bypass surgery to salvage an
angioplasty gone bad. In the words of Dr. Mandeep Singh, "We knew
there had been a reduction, but the magnitude of the reduction was a
surprise to us.... The bypass surgery rates, which were close to 3 percent,
came down to 0.3 percent in the most recent time period." related stories: Emergency
Coronary Artery Bypass Surgery for Percutaneous Coronary Interventions -- Journal
of the American College of Cardiology
November 29,
2005 Stent
vs. Scalpel (source: Barnaby J. Feder, New York Times)
An excellent overview of the controversy between CES and CEA (stenting
and surgery) discusses questions like which is better?; are both treatments
being over-used?; does opening up the carotid artery really prevent stroke?
related stories: Interview
with Christopher J. White -- Angioplasty.Org Conducted this spring, Dr. White, a cardiologist at the reknown
Ochsner Clinic in New Orleans, discusses indications for carotid stenting
and the current state of the art.
November 29, 2005 Boston
Scientific takes its show on the road (source: Stephen Heuser, Boston Globe)
A report on Boston Scientific's simulation bus, the SimSuite -- actually
two articles and an audiovisual slideshow.
November 29,
2005 Little-known
heart therapy helps squeeze out chest pain (source: Robyn Shelton, Orlando Sentinel)
An article from a Florida newspaper about EECP (Enhanced External Counterpulsation),
a non-invasive therapy to improve circulation that's been around for
a while and, amid skepticism, is being used to treat heart patients.
The PEECH study, presented at the ACC earlier this year, found that patients
suffering from congestive heart failure (CHF) had better exercise duration
when treated with EECP than with pharmacologic management alone. related stories: Vasomedical
Announces Positive PEECH Trial Results -- VasoMedical
Inc. (March 9 press release) Forum
Discussion Topic on EECP -- Angioplasty.Org
November
17, 2005 Medtronic
Submits First PMA Module for Talent™ Thoracic Stent
Graft System (source: Medtronic, Inc.)
From the company release: "Each year in America, thoracic aneurysms
affect approximately 30,000 people. Patients typically have no symptoms
and, when they are diagnosed, often undergo complex open surgical repair.
Many of these patients have other serious conditions such as coronary
artery disease, high blood pressure or diabetes that make surgical repair
difficult or impossible. For those patients, conservative medical management
or "watchful waiting" is sometimes selected as a treatment option. However,
this can lead to increased mortality and morbidity. Stent graft therapy
provides a minimally-invasive alternative, with reduced recovery times
and potentially improved survival rates."
November
15, 2005 Abbott
to Acquire License to Johnson & Johnson's Rapid Exchange
Catheter Delivery Technology (source: Abbott)
As expected, Abbott gets the Rapid Exchange RX technology from the J&J/Guidant
deal, as a requirement made by the FTC. This now means that Boston Scientific,
J&J/Cordis/Guidant and now Abbott have the capability of making systems
with Rapid Exchange, leaving Medtronic as the lone non-RX device manufacturer.
November
15, 2005 Smoking
Ban Reduces Heart Attacks in Colorado City by 27% (source: Helena MT Independent Record)
Backing up the results of a similar experiment in Helena, Montana, the
community of Pueblo, Colorado experienced 27% less hospital admissions
for heart attacks in the 18 months after a public smoking ban went into
effect. The Montana law was in effect only 6 months when a judge struck
down the law. Heart attack admissions went back up to previous levels
soon after.
related stories: Study:
Heart Attacks Drop With Smoking Ban -- Associated
Press Heart
attacks pared in Pueblo -- Denver Post
November 13,
2005 Major
advances in techniques, devices, medications spur update
of PCI Guidelines (source: American College of Cardiology)
Today the American College of Cardiology (ACC), American Heart Association
(AHA), and Society for Cardiovascular Angiography and Interventions (SCAI)
released the first major overhaul of professional guidelines for angioplasty
and stenting in four years. The guidelines take into account the drug-eluting
stent revolution, expanded applications for percutaneous coronary interventions
(PCI) and add to the growing body of practice-based medicine for treatment
of heart attacks, prescription of antiplatelet therapy post-PCI, etc.
While these guidelines tend to be conservative, of note is the recommended
use of drug-eluting stents as therapy for in-stent restenosis -- a use
not yet approved by the FDA for the stents currently available in the
U.S. Asummary
of the guideline updates can be found on the ACC website.
November 13,
2005 Stent
patients go home sooner if wrist artery used (source: Reuters)
The Canadian study acronymed EASY (Early Discharge After Transradial
Stenting of Coronary Arteries Study), which was previously presented
at the Paris Course on Revascularization and the recent Canadian Cardiovascular
Congress, was presented at today's session of the American Heart Association
Scientific Sessions 2005, and so is finally receiving some press in the
U.S.. The radial (wrist) approach to threading a catheter into the coronary
arteries has been around for a number of years, but it requires special
training and skill on the part of the cardiologist (most catheter-based
procedures currently utilize the femoral or groin artery as an entry
point). ReoPro, or similar drugs, are routinely given after any stenting
to reduce complications from blood-clotting -- usually the patient is
kept overnight on an IV drip of the drug. What this study showed was
that the overnight infusion was not necessary and added no benefit to
a single dose -- the implication is that patients can go home the same
day, in effect transforming angioplasty with stenting into an outpatient
procedure. There is, however, debate in the medical community as to whether
patients should be kept overnight. One of the big advantages of radial
angioplasty is instant ambulation -- that is, the patient can walk around
shortly after the procedure and does not need to lie flat or have a vascular
closure device used, both of which occur in groin artery cases.
related stories: Angioplasty
Becoming Outpatient Procedure -- Associated
Press
November
7, 2005 St.
Jude Medical Named Medical Manufacturer of the Year (source: Medical Device & Diagnostic Industry)
The magazine has named three companies to this distinction, a large company,
a small public company and a small private company. St. Jude, maker of
implantable cardio defibrillators (ICD), Angio-Seal, heart valves and
many other devices is profiled in the story, "A Lot of Hard Work
and Just a Little Luck: St. Jude Medical proves that good processes and
a good reputation are key ingredients for success."
related stories: St. Jude
Medical Named Medical Device Manufacturer of the Year -- St.
Jude Medical
November
4, 2005 COMMIT
Trial: Addition of clopidogrel to aspirin safely reduces
mortality in patients with acute myocardial infarction (source: The Lancet)
The COMMIT Trial (ClOpidogrel and Metoprolol in Myocardial Infarction
Trial) randomized 45,852 patients to either clopidogrel (brand name --
Plavix) or placebo within 24 hours of admission for acute myocardial
infarction (heart attack) at 1,250 hospitals in the study. The use of
clopidogrel resulted in a 9% reduction in death, reinfarction, or stroke
with no significant excess risk. A 75mg dosage of the drug was continued
for up to 4 weeks. Clopidogrel (Plavix) is a crucial post-procedure medication
for stent patients (especially drug-eluting stents) but the COMMIT study
shows that its antiplatelet properties have a clear therapeutic effect
even when stents are not used.
related stories: Cheap
drugs could slash heart attack death toll -- Guardian
Unlimited A bit of currency exchange information is in order. "Cheap" in
England is £1.25/day (equal to $2.21 US) for Plavix; however,
in the United States, even through discount online sources such as Walgreens.com,
the drug costs almost twice as much ($4.20/day). Still, that's not
much more than a latte -- and it does more than wake you up. Sanofi's
Plavix May Reduce Heart Attack Deaths, Study Shows -- Bloomberg
November 3,
2005 Guidant
Sued By Spitzer for Misleading Doctors (source: New York State Office of the Attorney General)
Guidant's problems get worse as New York Attorney General Eliot Spitzer
filed a fraud lawsuit, stating that the company misled doctors about
a design flaw in a heart defibrillator. Spitzer said, "Concealment of
negative facts that might influence a consumer to purchase another manufacturer's
product is the essence of fraud."
related stories: Troubled
Maker of Heart Devices May Lose Suitor -- New
York Times Johnson & Johnson
Threatens To Pull Plug on Guidant Deal -- Wall
Street Journal
November 1,
2005 U.S.
Approval Is Expected Soon for Sale of Guidant (source: New York Times)
Speculation about whether or not Johnson & Johnson will go through
with acquiring Guidant or, if they do, how much lower the offer will
be will soon be over. Once the FTC approves the deal, the companies have
48 hours to sort things out. The price offered may be lowered due to
the recent revelations about problems with Guidant defibrillators.
related stories: FTC
could OK J&J-Guidant Tuesday -- Reuters
October 25,
2005 Cook
Offers First Fenestrated Endograft With CE Mark Approval
For Complex Aortic Aneurysms (source: Cook Incorporated)
The company announced that its advanced AAA endograft has received the
European CE Mark approval and that a pilot study is now ongoing in the
United States. This device allows endovascular (catheter-based) repair
of Abdominal Aortic Aneurysms.
October
20, 2005 Repeated
Defect in Heart Devices Exposes a History of Problems (source: Barry Meier, New York Times)
A major story discussing the defects in Guidant's defibrillators, and
the roles of the company, doctors, patients and the FDA. While not a
topic involving interventional cardiology, stents, balloons or angioplasty,
this article is about the world of medical devices, recalls and how they
impact the health of patients. Guidant's press release responding to
the NYT article is posted below.
related stories: Guidant
Response to Media Story on Product Performance -- Guidant
Corporation Guidant
may have leverage in talks with J&J -- Reuters
October
20, 2005 Guidant
Announces Positive Preliminary Results of Large Real-World
Carotid Artery Stenting Study (source: Guidant Corporation)
The company announced preliminary results of its study of carotid artery
stenting in high-risk patients, called CAPTURE (Carotid ACCULINK/ACCUNET
Post Approval Trial to Uncover Rare Events) -- an FDA-required post-approval
study to determine whether carotid artery stenting can be performed safely
in real-world clinical settings with physicians of varying levels of
experience. Initial results confirmed positive earlier data on carotid
stenting for high-risk patients. In addition, the study suggests that
carotid artery stenting can be performed safely by physicians of different
experience levels. The rate of death, stroke and myocardial infarction
within 30 days of the procedure was 5.1 percent.
October
17, 2005 Continued
Improvement and Outstanding Safety Seen with Boston Scientific's
FilterWire EZ™ Embolic Protection System
In about a third of surgical coronary bypass patients, saphenous vein
grafts (SVG) develop clogging; these clogs are then reopened using the
less invasive procedure of angioplasty. A problem has been that the interior
arterial wall and plaque in these SVGs are more prone to embolization,
where small pieces of the plaque break off and travel through the bloodstream
into smaller arteries, often causing Major Adverse Cardiac Events (MACE,
i.e. heart attack, etc.). To prevent this, embolic protection devices
are used to filter and catch the plaque and prevent them from traveling
onward. Still, the MACE rate is abolut 10%. Two registries presented
by Boston Scientific show MACE rates reduced to about 5% using their
FilterWireEZ (not yet approved in the U.S.). (source: Boston Scientific Corporation)
October
17, 2005 Volcano
Corporation Announces Pioneering Intravascular Ultrasound
(IVUS) Vulnerable Plaque Study (source: Volcano Corporation)
The SPECIAL (Study of Prospective Events in Coronary Intermediate Atherosclerotic
Lesions) trial is in collaboration with Goodman, Fukuda Denshi, Toyohashi
Heart Center, and will look at up to 2,000 stent patients in 100 hospitals
in Japan to study the natural history of the disease process of atherosclerosis.
While it has been thought for some time that heart attacks occurs when
the artery becomes blocked over time, it is now suggested that these
events may be more acute and related to the type of plaque -- a vulnerable
lipid-rich plaque that has not caused symptoms of angina may rupture,
block the artery, causing an infarction of the heart. The Volcano intravascular
ultrasound IVUS system can characterize not only the amount of plaque
but its tissue characteristics. Pauliina Margolis, M.D. PhD, Medical
Director for Volcano and study collaborator states, "The SPECIAL study
will collect critical new information about the role of vulnerable plaque
in unexpected heart attacks and about the natural progression of coronary
artery disease.... As a growing body of scientific knowledge about vulnerable
plaque is built, physicians may one day be able to better predict and
prevent heart attacks and plaque progression."
October
4, 2005 New
procedure cuts risk in Iowan's heart surgery (source: DesMoines Register)
One of the ironies of heart disease is that the patient who most needs
a coronary intervention (for example, a stent) may have a heart that
is too weak to have the procedure performed safely. The chances of a
serious complication or death during an interventional procedure or surgery
in this patient population is high. Should such a "high risk" procedure
have to be done, a device called an Intra Aortic Balloon Pump (IABP)
is often used to help support the pumping of the heart. But sometimes
it doesn't provide enough support, or can't be used. Another procedure
we've reported on called Percutaneous Cardiopulmonary Bypass Support
(PCPS) also addresses this problem (see
our interview with Dr. Fayaz Shawl) -- it is in effect a
bypass that is done in the cath lab without open heart surgery. But it
takes significant training to learn and time to perform. Two years ago
the FDA approved a device called the TandemHeart®, made by Pennsylvania-based CardiacAssist.
It is a small device that can be inserted percutaneously through the
same puncture in the groin that is used for angioplasty and stenting.
It takes about an hour to insert into the heart and certainly takes special
training to use but, as this article describes, it can provide enough
pumping power so that angioplasty/stenting (or other intervention) can
be performed much more safely in a "high risk" patient.
September
29, 2005 Trial
Will Look At Widening Angioplasty's Reach
Cardiologists at Johns Hopkins have launched a nationwide study of more
than 16,000 patients to see if angioplasty can be safely performed in
smaller, community hospitals, easing access to the therapy for patients.
Researchers expect to enroll the first study patients in this fall. This
controversial topic was the subject of one of the earliest
postings on our Forum -- by Johns Hopkins interventional
cardiologist Thomas Aversano, M.D. who is leading the above study. (source: Robert Preidt, HealthDay)
September 28, 2005, 2006 Cordis
Corporation Acquires LuMend, Inc. (source: Cordis Corporation)
Cordis Corporation, a Johnson & Johnson company, today announced the
acquisition of LuMend, Inc., a privately held company focused on the
development of chronic total occlusion (CTO) devices to treat peripheral
vascular disease.
September
16, 2005 Boston
Scientific Receives FDA Clearance for Flextome™ Cutting
Balloon® Dilatation Device (source: Boston Scientific Corporation)
The FDA has now approved this improved version of an earlier Cutting
Balloon -- this one is more "deliverable". The problem it addresses
is that during angioplasty the plaque itself splits apart when the balloon
expands. In a complex lesion, this splitting may be quite eccentric and
unpredictable; sometimes difficult and not possible even under high pressures.
Sometimes hard plaque can dissect or rip the arterial wall. This new
device uses tiny longitudinal blades to slice into the plaque before
expansion, making the angioplasty easier, more predictable and successful.
July 25, 2005 Carotid
therapy studied at Christ Hospital (Cincinnati)
Report on an NIH study being conducted, comparing surgery vs. carotid
stenting in low surgical risk patients. The stenting procedure is currently
recommended only for high surgical risk candidates. (source: Roy Wood, Cincinnati Post)
July 19, 2005 Magical
Medicine on TV
Dr. Jauhar provides a review of the TV show "House". Read more
comments in our Editor's
Blog. (source: Sandeep Jauhar, M.D., New York Times)
July 15, 2005 More
Americans Go Online For Health-Care Information
The actual number of adults who have ever searched for health information
online has grown due to an increase in the percentage of U.S. adults
who go online (from 66% in 2002 to 74% in 2005). Approximately 117 million
adults have searched for health information in the past year, and almost
six in 10 (58%) say that they have looked for information about health
topics often (25%) or sometimes (33%), an increase of eight percentage
points from 2004 (50%). (source: Harris Interactive)
July 11, 2005 Paswan's
brother for CBI probe into Escorts' medical advice
A story from New Delhi, India, about bypass surgery vs. angioplasty in
the case of MP and Union Minister Ram Vilas Paswan -- turns out the original
hospital he went to recommended immediate surgery without question --
but a noted cardiologist from a different hospital said angioplasty was
indicated. Minister Paswan was transferred, had the angioplasty, is at
work from his hospital room and is expected to be discharged in a day
or two. (source: The Hindu)
July 5, 2005 For
Heart Disease, a Joint Effort
A report about a hybrid procedure offered in Maryland which combines
coronary artery bypass grafting (CABG) with Angioplasty/Stenting in a
single procedure, using the philosophy that both therapies work for different
types of cases. The procedure is not without controversy. (source: Naseem Sowti, Washington Post)
July 4, 2005 Cubin
hospitalized for mild heart attack
Rep. Barbara Cubin (R-Wyo) suffered a mild heart attack at Dulles International
Airport and was taken to a Washington-area hospital where an angioplasty/stent
was done. Her spokesman said she was in good spirits and "joked
that she's always trying to follow in Dick Cheney's footsteps but this
was going too far.'' (V.P. Cheney has had four heart attacks.) (source: Caspar Star Tribune)
June 28,
2005 Recalls
cast spotlight on medical device sector
The latest recall from Guidant is discussed in the context of other high
profile device recalls over the past year. Recalls are a complex area
-- read our feature "What's
a Patient To Do" which was specifically about the Boston Scientific
stent recall of last summer, but has information about devices recalls
in general. (source: Susan Kelly, Reuters)
July 4, 2005 The
Frontier: Interventional Radiology
A feature in the July 4 issue of Newsweek profiles the field of IR, Interventional
Radiology, and the advances being made in catheter-based treatments outside
of the heart. (source: Robert Bazell, Newsweek)
June
22, 2005 Centers
for Medicare and Medicaid Services Initiates Review for
Expanded Reimbursement Coverage of Vasomedical's EECP® Therapy (source: Vasomedical, Inc.)
The company has been notified by the Centers for Medicare and Medicaid
Services (CMS) that the application requesting consideration for expansion
of the national coverage for EECP® therapy has been accepted. The
company currently markets the therapy for chronic stable angina and congestive
heart failure and has been actively working to expand Medicare reimbursement
coverage for less severe angina and to include coverage for congestive
heart failure as a primary indication.
June 21, 2005 Heart
Rhythm Society to Develop Guidelines on ICD Recalls
In reaction to the recent recalls from Guidant, and earlier from Medtronic,
the Heart Rhythm Society is calling together a task force to ensure that
recall information in implantable devices (defibrillators, pacemakers,
etc.) is reported to both physicians and patients in a standardized way. (source: Heart Rhythm Society)
June 20, 2005 Recall
of certain Guidant implantable heart devices
The AHA's statement on Guidant's recall of defibrillators. The models
are PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002,
CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004,
CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004 (source: American Heart Association)
June 14, 2005 Acute
coronary syndrome patients at increased risk of stroke
A study published in the current Circulation shows that patients admitted
for acute heart problems have a higher rate of stroke, both in the hospital
and after discharge -- this confirms that what medicine knows but need
to pay far more attention to -- vascular disease occurs in different
parts of the body -- in the coronary arteries it causes heart attacks;
in the carotids it causes strokes; in the renals, it causes kidney disease;
in the legs, PAD -- but these seeming different manifestations are all
related and often occur together. (source: American Heart Association)
June 2, 2005 Palestinian
Leader Has Heart Procedure
Palestinian leader Mahmoud Abbas is recovering from angioplasty performed
Wednesday at a hospital in Jordan. Abbas was taken to a hospital in Amman,
Jordan Wednesday complaining of fatigue, said Tayeb Abdel Rahim, a top
Abbas aide. He underwent angioplasty, a procedure to clear out clogged
coronary arteries. (source: Mohammed Daraghmeh, Guardian Unlimited)
May 30,
2005 Statins
underprescribed to patients at higher risk of heart disease
A study published in the May issue of the Public Library of Science-Medicine by
a Stanford team, headed by lead author Jun Ma, MD, PhD, found that statins,
although their benefit in lowering cholesterol is well-known, are still
not being prescribed for the patients who need the therapy most. Dr.
Ma stated that while she was encouraged that statin use has increased, “it’s
disconcerting that the magnitude of the increase is much smaller than
expected. The rate of use falls significantly short of the latest recommendations.” Ma
also noted that although statin use is greatest among the high-risk group,
physicians should be more aggressive in looking at statin therapy for
moderate-risk patients. “Prevention is key for delaying the onset
of cardiovascular disease. If we start intervention early enough, we
can delay the progression of the disease and reduce the health-care costs
overall.” (source: Stanford University Medical Center)
May 25, 2005 Noninvasive
Coronary Angiography With Multislice Computed Tomography
MSCT is a technology that has been talked about as an alternative to
cardiac catheterization. It is not catheter-based and therefore avoids
the complications of percutaneous procedures (about 1.8%). Today's study
in JAMA reports on 103 patients in Germany who underwent both invasive
coronary angiography and MSCT (using a scanner with 16 detector rows
manufactured by Philips Medical Systems). The authors from University
Hospital in Ulm, Germany, conclude that MSCT is effective in pre-screening
patients for coronary angiography. For example, 45 patients showed no
or insignificant coronary disease on their angiogram, currently the "gold
standard" for diagnosis. However, the less invasive MSCT identified
38 of these patients correctly -- that means 84% of these patients could
have avoided getting a cardiac catheterization. There were only 2 patients
who had coronary artery narrowing that were missed by the MSCT and it
is thought that with the current state-of-the-art technology (40 and
64 detector rows) these too may have been found. The authors conclude: "With
rapidly improving technology, MSCT may well evolve from a useful complement
to invasive angiography to a clinically viable alternative." This
would truly be a revolution in imaging for patients (reduced complications)
and healthcare systems (reduced costs). (source: Journal of the American Medical Association)
related stories: Multislice
Computed Tomography Has Potential To Offer Accurate,
Safer Method for Detecting Coronary Artery Disease -- Journal
of the American Medical Association
May
19, 2005 Relation
of Interhospital Delay and Mortality in Patients
With ST-Segment Elevation Myocardial Infarction
Transferred for Primary Coronary Angioplasty
Published online today, this study confirms the fact that that longer
the delay in treating STEMI (ST elevated myocardial infarction) patients
with angioplasty / stenting, the worse the outcome. As can be seen
in this graph, 1-year mortality increased from 3.2% to 12.1% as the
time delay due to interhospital transfer increased from less than
30 minutes to greater than 90 minutes. Moral of the story: these
times need to be reduced. Patients with treatable MI should try to
get to a hospital that can perform angioplasty. (source: American Journal of Cardiology)
Time delay in min. vs.
% mortality at 1-year
May 17, 2005 Market
for neck artery stents set to heat up
Carotid stents and stenting, a balloon/stent alternative to open surgery
to clean out the carotid artery is starting to become a force in the
device industry. For more on this new procedure, read our recent
interview with Dr. Christopher J. White of the Ochsner Clinic. A
feature story on the state of carotid stenting will be posted on Angioplasty.Org
next week. Register for
our newsletter to be notified. (source: Susan Kelly, Reuters)
May 16, 2005 Class
Matters: Heart Attacks, and What Came Next -- Life at the
Top in America Isn't Just Better, It's Longer
This excellent article (part of a special New York Times series, "Class
Matters") profiles three New Yorkers who had heart attacks. The
article traces their treatments and outcomes, against the backdrop of
their economic class. The most successful of the three treatments was
-- emergency angioplasty. The article states, "An important link
in the safety net that caught Mr. Miele was his wife.... While Mr. Miele
was still in the hospital, she was on the Internet, Googling stents." We'd
like to think that she read our article, "Angioplasty
and Heart Attack". (source: Janny Scott, New York Times)
April 27, 2005 Boston
Scientific Announces Excellent Results in Study of Patients
With Carotid Artery Disease
The one-year data from the BEACH carotid artery stenting (CAS) clinical
trial were presented today at the 14th
Annual Peripheral Angioplasty and All That Jazz meeting in New Orleans
by Christopher White, M.D., of the Ochsner Heart and Vascular Institute
in New Orleans. The BEACH trial was designed to evaluate Boston Scientific's
Carotid WALLSTENT® Monorail® Endoprosthesis (Carotid WALLSTENT) and the
FilterWire EX™ and EZ™ Embolic Protection Systems and evaluated
the effectiveness of stenting with embolic protection for patients who
are at high-risk for the traditional surgical treatment of carotid endarterectomy
(CEA). The combined endpoint of stroke, death or heart attack at one-year
with the stent was 9.1%, lower than the results from the SAPPHIRE trial
reported in October 2004 (that trial showed stenting with a 12.2% and
open surgery with a 20.1% mortality or morbidity in the first year).
The study included a subset of patients with carotid disease in both
left and right arteries, a population considered harder to treat and
one that has not been previously studied. This group showed an event
rate of 7.1%. (source: Boston Scientific Corporation)
April
22, 2005 Abbott
Reviews 2004 Accomplishments at Annual Shareholders'
Meeting
A press release from Abbott, a company which has begun drug-eluting stent
trials for its Zomaxx™ stent in Europe and also recently submitted
its new StarClose® vascular closure
device for FDA approval. The company's Xact® Carotid
Stent System and Emboshield® Embolic Protection System for
carotid stenting is also currently under FDA review. (source: Abbott Laboratories)
April 21, 2005 Guidant
Reports Record First Quarter Sales of $953 Million
The company's report contains some statements about the upcoming merger
and, a sign of the change in the field of angioplasty / stenting, stent
sales (Guidant only sells bare metal stents) were down 33%. This, of
course, will change in the near future, when the Guidant/J&J merger
occurs. (source: Guidant Corporation)
April 19,
2005 Boston
Scientific Announces First Quarter Results
The company announced financial results showing $721
million in stent sales worldwide. In a conference call with analysts
this morning, COO Paul LaViolette stated that the Taxus stent currently
has 61% of the U.S. market. (source: Boston Scientific Corporation)
April 13, 2005 EndoTex
Interventional Systems Announces European Approval of Novel
Carotid Stent Delivery System Boston
Scientific Begins Exclusive International Distribution
of NexStent™ Carotid Stent
Both companies announce that Endotex's NexStent™ Carotid Stent
and Monorail™ Delivery System has received the CE Mark of approval
in Europe and that Boston Scientific will begin exclusive distribution
of it. Matthew Jenusaitis, President of Boston Scientific's Peripheral
Interventions business, states, "The NexStent carotid stent, used in
combination with the Boston Scientific FilterWire EZ™ embolic protection
system, offers patients a less-invasive treatment alternative to the
traditional surgical procedure known as a carotid endarterectomy." (source: Boston Scientific Corporation / EndoTex Interventional
Systems, Inc.)
April 11, 2005 Abbott
Submits StarClose™ Vascular Closure Device for FDA
Approval
Abbott Vascular today announced the submission of a Premarket Approval
application to the U.S. Food and Drug Administration (FDA) for its StarClose™ Vascular
Closure System, a next–generation vessel closure system specifically
designed for the simple, quick and secure mechanical closure of femoral
arteries following catheterization procedures, such as angioplasty and
stent placement. Abbott Vascular President Robert B. Hance stated, "As
a leader in vessel closure, Abbott is pleased to announce this important
step in the development of a next–generation closure device for the U.S.
market.... In our pivotal clinical study, StarClose was shown to close
femoral arteries securely and safely in a matter of seconds, reducing
the amount of time patients need to remain at bedrest following a catheterization
procedure." (source: Abbott Laboratories)
April 6, 2005 Shedding
new light on coronary bypass surgery
Although this article is not about interventional procedures per se,
it does illustrate how changes in imaging technology can imporve patient
outcomes -- and this new imaging is being performed by Peter Fitzgerald,
MD, PhD of Stanford, one of the pioneers of intravascular ultrasound
and its use in the coronaries. (source: Stanford University)
March 31, 2005 Former
Secretary of State Kissinger undergoes heart procedure
Kissinger, who is almost 82, underwent angioplasty on Tuesday and is
now "resting comfortably at home," according to Myrna Manners
of New York-Presbyterian Hospital/Weill Cornell Medical Center in Manhattan. (source: Newsday)
March 30, 2005 Hoag
Hospital Announces First U.S. Patient Enrolled in ACT I
Clinical Trial
The first patient in the U.S. to be enrolled in the clinical trial named “Carotid
Angioplasty and Stenting vs. Endarterectomy in Asymptomatic Subjects
with Significant Extracranial Carotid Occlusive Disease Trial” (ACT
I) was treated today at the Hoag Heart and Vascular Institute at Hoag
Memorial Hospital Presbyterian in Newport Beach, CA. ACT I is the first
trial to study the potential benefits of minimally invasive carotid stenting
in patients who would normally undergo surgery, carotid endarterectomy
(CEA), to prevent stroke. (source: Hoag Hospital)
March 25, 2005 Blue
Cross And Blue Shield Association Study Shows Consumers
Want Information To Help Them Make Healthcare Treatment
Decisions
A RAND Corporation study for Blue Cross and Blue Shield shows that 70
percent of consumers surveyed said they turn to the Internet most often
to find the information they need to make treatment decisions. About
60 percent said they also go to their doctor. "This is a clear indication
we should empower consumers to become better informed when making critical
healthcare decisions,” said Maureen Sullivan of Blue Cross/Blue
Shield. “The challenge for physicians, hospitals and payers is
to provide information to consumers in an easy-to-use format that helps
them understand their treatment choices." (source: Blue Cross and Blue Shield)
March 24, 2005 Boston
Scientific Announces Jury Verdict in Patent Litigation
with Johnson & Johnson
The company's press release discusses the jury verdict validating one
of several claims that Johnson & Johnson said infringed on its Palmaz
patent (the other claims were not found to infringe). The product involved
was the NIR® stent, which was designed and manufactured by Medinol
Ltd. and formerly sold by Boston Scientific. It is an older product and
no longer sold. A news article from Reuters, titled "US
jury rules against Boston Scientific on patent" discusses the
situation futher. (source: Boston Scientific Corporation / Reuters)
March 17, 2005 Boston
Scientific disputes article on Medinol
The company disputes the information in an article (below) from the Israeli
newspaper Yediot Ahronot and company spokesperson Paul Donovan
stated, "We have had no discussions with Medinol for quite some
time regarding settlement of our disputes, and we have made no settlement
offers of any kind or any amount." (source: Reuters) Boston
Scientific offers Medinol $600m compensation
The “Yediot Ahronot” Hebrew daily reports that negotiations
to settle the bitter dispute between Israel stent manufacturer Medinol,
owned by Kobi and Judith Richter, and US company Boston Scientific, Medinol’s
former partner, have reached an advanced stage. (source: Golan Hazani - "Yediot Ahronot")
March 15, 2005 Boston
Scientific Receives Two FDA Approvals on Cutting Balloon™ Product
Line
Press release from the company announced that the FDA has granted approvals
to the company for its Quincy Massachusetts Distribution Center as a
sterilization site and its Letterkenny, Ireland facility for manufacturing
of the Cutting Balloon product line. (source: Boston Scientific Corporation)
March
8, 2005 Vasomedical
Announces Positive PEECH Trial Results at American College
of Cardiology (source: Vasomedical, Inc.)
The most recent study of the effects external counterpulsation therapy
(ECP or EECP) were presented today at the ACC. The PEECH™ (Prospective
Evaluation of EECP® in Congestive Heart Failure) study, while small (187
patients in 29 centers) showed benefits and the results "support
the use of EECP therapy as an adjunctive treatment for chronic stable
heart failure patients", accordingly to principal investigator Dr.
Arthur Feldman of Jefferson Medical College of Thomas Jefferson University,
Philadelphia.
February 21, 2005 Doctors
in state try stent in artery
A story about a patient treated at Sparks Regional Medical Center in
Fort Smith, Arkansas with a carotid stent (the Rx Acculink and Rx Accunet
by Guidant). Gives a good picture of the procedure. (source: Tracie Dungan, Arkansas Democrat Gazette)
February 18, 2005 Study
Suggests Non-Surgical Cryoplasty® Therapy Promising
Treatment For Blocked Leg Arteries
Positive results from patients treated at the Texas Heart Institute for
Peripheral Artery Disease (PAD) were presented at the International Congress
on Endovascular Intervention XVIII today. This new therapy uses nitrous
oxide in a balloon catheter inside of saline to cool the artery to -10°C
before and during balloon expansion. The results in leg arteries have
been very good, significantly reducing the need for the additional treatment
of stent placement. An information packet on cryoplasty for physicians
and patients is available at cryoplasty.com. (source: CryoVascular Systems, Inc.)
February 18,
2005 Jury
rules against Medtronic in stent patent
A jury in a Delaware court ruled that some Medtronic's stent designs
infringed on patents held by rival stent-maker Guidant. The ruling had
to do with older stents, according to Medtronic's
press release, they are the Microstent, GFX, GFXII, S540, S660, S7,
Driver, Bridge, and BeStent2 -- most these basic designs were inherited
from Arterial Vascular Engineering (AVE) when Medtronic purchased them
in 1998. (source: Reuters)
February 18, 2005 Info
Sought on Planned J&J-Guidant Merger
The Federal Trade Commission (FTC) has asked for more information from
Johnson & Johnson and Guidant on the two companies' planned merger.
In a joint
statement, the companies indicated that the request was anticipated,
adding that they still expect to receive regulatory approval and close
the acquisition during the third quarter of this year. For a history
of the merger talks, see our special
section. (source: Associated Press)
February 16,
2005 Clopidogrel
plus Aspirin: Cost-Effective for a Year
A study published yesterday by Mark D. Schleinitz, MD, MS, of Brown University
and P.A. Heidenreich, MD, MS of Stanford showed that patients with high-risk
acute coronary syndromes (unstable angina) not only lived slightly longer
when given a combination of clopidogrel (brand name: Plavix) and aspirin
for the first year after a cardiac event, as opposed to aspirin alone,
but that this treatment was "cost-effective", even when taking
into account the increased cost of clopidogrel. (source: Annals of Internal Medicine)
February 16, 2005 Coil
Embolization Treatment 'Safe and Effective,' According
to British Health Authority Advisory Committee
Demonstrating yet again the genius of Charles Dotter in conceiving of
the circulatory system as a "highway of the body", the Interventional
Procedures Advisory Committee (IPAC) of the United Kingdom's National
Institute for Clinical Excellence (NICE), has confirmed the safety and
efficacy of coil embolization for the treatment of ruptured and unruptured
brain aneurysms. "Coil embolization offers patients with a ruptured
aneurysm a safer and less- invasive treatment with an improved chance
of recovery for a condition that could easily be fatal," said Anil
Gholkar, M.D., consultant neuroradiologist, of the Regional Neurosciences
Centre in Newcastle-upon-Tyne, England. (source: Boston Scientific Corporation)
February 15,
2005 Guidant
Corp. Recalls Some Catheters
This voluntary recall involves balloons that are used to open clogged
arteries, specifically the Voyager Coronary Dilatation Catheters of sizes
1.5 mm to 3.5 mm (the Voyager RX was not part of the recall). The Voyager
was launched
last July after F.D.A. approval. The reason given is a possible leak
which could allow air into the system. The company states in its filing, "While
the probability of a leak is low, the company is pursuing root cause
analysis and corrective actions." (source: Associated Press)
February 14, 2005 Quitting
Smoking Improves Blood Tests in Days
A Japanese study found that 2 weeks after stopping smoking made the blood
significantly less likely to form clots (one of the major ways in which
heart attacks occur). This doesn't mean that the effects of smoking on
the body are reversed in such a short period, but it does show an immediate
and very important benefit to smoking cessation. (source: Reuters)
February
7, 2005 Surgery
or angioplasty? New scale helps physicians choose best
heart treatment
In the current issue of the AHA's journal Circulation, Dr. John
Spertus of the Mid America Heart Institute of Saint Luke’s Hospital
in Kansas City, Missouri, reports the results of a study in which outcomes
of patients with varying levels of "restenosis risk" were rated.
The report titled, "Risk of Restenosis and Health Status Outcomes
for Patients Undergoing Percutaneous Coronary Intervention Versus Coronary
Artery Bypass Graft Surgery" (read
the abstract here) showed that bypass surgery was better for patients
with a medium-to-high risk of restenosis (as rated using a scale developed
for the study). However, the study was based on patient data from 1999-2000
which pre-dates the drug-eluting stent, a major new device which significantly
reduces the risk of restenosis. The authors, recognizing the impact of
this new modality, conclude that the risk of restenosis "...should
also be tested as a means for considering drug-eluting as opposed to
bare metal stents in PCI." For a further discussion of this
study, also see our Editor's
Blog. (source: American Heart Association)
February 7, 2005 Study
Shows "Time to Treatment" for Heart Attack Using
Angioplasty in the U.S. Takes Too Long
This study used data from the National Registry of Myocardial Infarction
to see how quickly the transfer of heart attack patients to 419 hospitals
that perform angioplasty was being done in the "real world".
Previous studies have shown that angioplasty (or "primary PCI" --
Percutaneous Coronary Intervention) has clear benefits for treatment
of myocardial infarction (see our Feature
Topic) if done within 90 minutes, currently the national guideline.
But this study reveals that the "door-to-balloon" time (the
period covering the patient arriving at the first hospital, diagnosed,
transferred to the second, brought into the cath lab and a balloon inflated)
was within 90 minutes in less than 5% of patients, with a mean time of
double that. Angioplasty is still theoretically the best treatment but,
as the authors conclude, "For the full benefits of primary PCI to
be realized in transfer patients, improved systems are urgently needed
to minimize total door-to-balloon times." (source: Harlan M. Krumholz MD et al, Circulation)
February 7, 2005 Gum
Disease Seems to Clog Arteries
A study, published in this week's Circulation,
show a direct relationship between high levels of periodontal bacteria
that cause gum disease and early stages of atherosclerosis. The study
used ultrasound measurements of the arterial wall in carotid (neck) arteries. (source: E.J. Mundell, HealthDay)
February 7, 2005 Abbott
Enters Into Agreement with Cleveland Clinic for Myeloperoxidase
(MPO) Cardiac Test
MPO's link to inflammation in coronary arteries from unstable plaque
could make it a potential biomarker useful for risk stratification in
patients presenting with chest pain. "Today, cardiac diagnostic
tests already influence how treatment recommendations are made. The potential
of an MPO test to help identify patients at risk for a major cardiac
event in the near term could prove to be another advance in patient care," said
Stanley Hazen, M.D., Ph.D., head of the Section of Preventive Cardiology
and Cardiac Rehabilitation at The Cleveland Clinic. (source: Abbott Laboratories)
February 1, 2005 Zylon
Corporation awarded major grant from NIH
The National Heart Lung and Blood Institute of the National Institutes
of Health has awarded a research grant to further develop Zylon's innovative "Ultra
low profile coronary stent delivery catheter". (source: Zylon Corporation)
January 27, 2005 Abbott
sets trial of carotid stents
Another story about Abbott's carotid stenting trial, comparing the less
invasive endovascular approach to conventional "open" surgery. (source: Bruce Japsen, Chicago Tribune)
January 19, 2005 St.
Jude Medical Ships 5 Millionth Angio-Seal Vascular Closure
Device
In the company's press release Paul R. Buckman, President of St. Jude
Medical's Cardiology Division states: "St. Jude Medical's Angio-Seal™ device
is now chosen by more physicians than any other vascular closure technology....
Many healthcare providers have concluded that the use of vascular closure
devices has become an indispensable part of the catheterization procedure.
The shipment of the 5 millionth Angio-Seal™ device signifies the
market's overwhelming acceptance of this technology. It is truly becoming
the standard of care for obtaining hemostasis." (source: St. Jude Medical, Inc.)
January 18, 2005 Abbott
Announces Groundbreaking New Trial in Stroke Prevention
The company announced today that it will begin enrolling patients in
its recently FDA-conditionally-approved clinical study, called the Asymptomatic
Carotid Trial or ACT I. It will be a multicenter, randomized trial that
will compare carotid artery stenting to carotid artery surgery in asymptomatic
patients (those who have not displayed symptoms of a stroke but are at–risk)
who normally would be referred for surgery. This is the first such major
trial of its type. Another
article from Reuters about the trial quotes Dr. Takao Ohki, chief
of vascular surgery at Montefiore Hospital in New York: "From an
industry standpoint, it has big opportunity. From a clinician and patient
standpoint, it would allow us to have more options in terms of what kind
of treatment we could offer." You can see and hear Dr. Ohki and
many other vascular surgeons who are pioneering the endovascular option
in our documentary, "Vascular
Pioneers: Evolution of a Specialty". (source: Abbott Laboratories / Reuters Health / VascularTherapy.Org)
January 18, 2005 Absorbable
Metal Stent Opens Blocked Leg Arteries
Initial results with a bio-absorbable metal stent show that the novel
device works as intended -- to prop open blocked leg arteries before
being fully absorbed into the artery wall, so that complications common
with standard stents don't occur. (source: Megan Rauscher, Reuters)
January 18, 2005 Reinsdorf
OK after angioplasty
White Sox and Bulls owner Jerry Reinsdorf underwent artery-clearing angioplasty
Monday after routine tests found minor blockage, the White Sox said. (source: NorthWest Herald)
October
20, 2005