August 10, 2010
DES
'n' DAPT: The OPTIMIZE Trial and Drug-Eluting Stents
Commentary from the Editor's Blog: Do patients understand that they must take
dual antiplatelet drugs for a year or more after drug-eluting stent implantation?
Is it possible that a year may
not be necessary? The OPTIMIZE and SEASIDE Trials may provide some answers.
The DAPT Trial, not so much. (Read
more...)
August 8, 2010
Medtronic Opens Patient
Care Centre in Beijing, China
Medtronic (NYSE: MDT) today opened a Patient Care Centre in Beijing, China,
the first of its kind in China and worldwide where patients and their relatives
meet with medical technology experts and physicians to discuss medical technology
options to treat the patient's chronic disease. The Medtronic Patient Care
Centre is operated in cooperation with the National Centre for Cardiovascular
Diseases (NCCD) of China. (Read
more...)
August 6, 2010
Medtronic Completes Enrollment
in Clinical Study of Complete SE® (Self-Expanding) Vascular Stent
With an expanded focus on addressing peripheral arterial disease (PAD), Medtronic,
Inc. (NYSE: MDT), today announced that it has completed enrollment in a clinical
trial of the company’s Complete SE (self-expanding) vascular stent for the
treatment of atherosclerosis in the superficial femoral artery (SFA), including
the proximal popliteal artery (PPA), which runs under the skin of the thigh. (Read more...)
August 5, 2010
First Patient Treated
with Medtronic’s Valiant® Thoracic Stent Graft in Aortic Dissection
Trial
Marking a major milestone toward expanding the use and utility of minimally
invasive endovascular procedures, Medtronic, Inc. (NYSE: MDT), today announced
the enrollment of the first patient in the Medtronic Dissection Trial, which
is evaluating the clinical performance of the Valiant Thoracic Stent Graft
with the Captivia Delivery System for the treatment of acute, complicated Type
B aortic dissection – a serious cardiovascular condition associated with high
morbidity and mortality. (Read
more...)
June 23, 2010
To
Stent or Not To Stent: Fractional Flow Reserve (FFR) Trumps Angiography
in Diagnosing Blockages up to 90%
The authors of a new study pubished in JACC conclude: "In patients with multivessel
CAD, coronary angiography is an inappropriate tool to identify ischemia-producing
stenoses as detected by the FFR. This discrepancy between angiographic and
functional stenosis severity is not only present in the 50% to 70% stenosis
range but also in the 71% to 90% stenosis range." (Read
more...)
May 27, 2010
Stent
Helpers: IVUS, OCT and FFR -- Intravascular Tools At EuroPCR
Commentary from the Editor's Blog: Three intravascular
imaging/therapeutic modalities have been making news this
month, both in the U.S. and in Paris at the EuroPCR meeting
ending tomorrow. They are Optical Coherence Tomography
(OCT), Intravascular Ultrasound (IVUS) and Fractional Flow
Reserve (FFR). (Read
more...)
May 26, 2010
Medtronic
CoreValve® System Shows Long-Term Efficacy and Durability
in Pivotal Trial
New clinical data presented today at EuroPCR demonstrate positive long-term
performance and durability for the CoreValve transcatheter aortic valve replacement
system from Medtronic, Inc. (NYSE: MDT).
Two-year results from the pivotal 18-French CoreValve multicenter prospective
study provide important additional evidence supporting wider use of the world’s
market-leading transcatheter aortic valve. (Read more...)
May 25, 2010
Multiple
European Clinical Registries Show Important Benefits of Medtronic CoreValve® Transcatheter
Aortic Valve System
New European data from five national clinical registries presented today at
EuroPCR report positive clinical outcomes for one of the most exciting emerging
therapies in cardiology – transcatheter aortic valve implantation for treatment
of severe aortic stenosis. The registries’ results demonstrate encouraging
clinical outcomes for more than 2,000 patients treated with the CoreValve percutaneous
aortic valve system from Medtronic, Inc. (NYSE: MDT). (Read
more...)
May 25, 2010
Medtronic’s
Resolute® Drug-Eluting Stent Matches Market-Leading Rival in Large
Head-To-Head Study
At one year, the Resolute DES was shown to be as effective as the Xience DES
in reducing the need for repeat procedures, and both second-generation stents
were associated with low and similar rates of death from cardiac causes and
heart attacks attributed to the treated vessel. (Read
more...)
May 20, 2010
Cardiovascular Devices
from Medtronic Featured Prominently at EuroPCR
Medtronic, Inc. (NYSE: MDT), announced today the schedule of important clinical
data presentations during EuroPCR, a major cardiology meeting taking place
May 25–28 in Paris at the Palais de Congrès. The meeting will prominently feature
several of Medtronic’s innovative cardiovascular devices, including the Resolute
coronary drug-eluting stent, the IN.PACT line of coronary and peripheral drug-eluting
balloons, and the CoreValve transcatheter aortic valve replacement system. (Read
more...) May 19, 2010
First
Patient Treated with Valiant® Thoracic Stent Graft in Medtronic’s “RESCUE” Clinical
Study
Further demonstrating its commitment to proving the benefits of minimally-invasive
procedures, Medtronic, Inc. (NYSE: MDT), today announced that the first patient
has been treated with the company’s Valiant® Thoracic Stent Graft
with the Captivia Delivery System in Medtronic’s RESCUE Clinical Study. (Read
more...)
May 16, 2010
Stent
Inventor's New Ideas
From the Editor's Blog: Stent pioneer Dr. Julio Palmaz was in the news this
week regarding a $3 million investment made in his company Palmaz Scientific
by the State of Texas. Steve Solomon, CEO of Palmaz Scientific, states that
his company "will use a portion of the money to help secure approval in the
European market of its Sesame stent, which has a special microscopic mesh coating
that helps reduce the effect of impurities in the metal tube. The state funds
also will be devoted to buying equipment and hiring engineers to spur the development
of next-generation stents." (Read
more...)
May 5, 2010
The
New England Journal of Medicine Publication of SPIRIT IV Trial Results
Confirm Superior Safety and Efficacy of Abbott's XIENCE V® Drug Eluting
Stent Compared to TAXUS
Findings from Abbott’s SPIRIT IV trial, one of the largest randomized clinical
trials comparing two drug eluting stents, with 3,690 U.S.-based patients, were
published today in The New England Journal of Medicine. The published study
results show that one year after a stenting procedure, patients treated with
Abbott’s market-leading XIENCE V® Everolimus Eluting Coronary Stent System
were significantly less likely to have a major adverse event such as a heart
attack, repeat procedure or cardiac death, compared to patients treated with
a TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System (TAXUS). (Read
more...)
April 21, 2010
Medtronic Receives FDA Approval for New Indication for Complete® SE Vascular Stent Broadening the scope of innovation for cardiovascular interventions beyond the heart, Medtronic, Inc. (NYSE: MDT), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the Complete® SE Vascular Stent System to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries, major blood vessels within the pelvis that supply blood to the lower extremities. (Read more...)
April 13, 2010
TCT 2010 to Feature New
Heart Stents, Catheter-Based Valve Repair/Replacement and Drug Effectiveness
TCT 2010 (Transcatheter Cardiovascular Therapeutics) will provide significant
clinical research updates to technologies and practices in interventional cardiology
that will directly affect patient care.
At TCT 2010 (September 21-25 in Washington, DC), late breaking data from clinical
trials on the next generation of stents, valve repair and replacement, and
the interactions and effectiveness of new medicines will shed light on the
best ways to treat patients. (Read
more...)
March 16, 2010
If Women Were Treated
More Like Men, Would Survival After Heart Attack Improve?
Women might be more likely to survive a heart attack if they were treated more
like men, with increased use of angioplasty and other invasive techniques,
according to research presented today at the ACC
59th annual scientific session. In a multicenter study of more than 3,000 patients
admitted to the hospital for a heart attack, women were far less likely than
men to go to the cardiac catheterization laboratory for angiography or angioplasty,
and about twice as likely to die within a month of having the heart attack.
But when a special statistical method was used to closely match patients by
both baseline clinical characteristics and treatments, death rates were similar
among men and women. (Read
more...)
March 15, 2010
Stent News from the ACC.10:
Monday
All four U.S. stent manufacturers were represented in various studies presented
at today's 59th Annual Scientific Sessions of the American College of Cardiology
in Atlanta, GA, an event attended by an estimated 16,000 cardiology professionals.
The studies revealed data about old vs. new devices, and the results ranged
from unsurprising to controversial to unparalleled. (Read
more...) March 15, 2010
Medtronic
Responds to SORT-OUT III Stent Study
Medtronic, Inc. (NYSE: MDT), responded today to the questionable findings of
SORT-OUT III, a Danish study comparing the Endeavor and Cypher drug-eluting
stents.
The company’s criticisms cover the study’s unconventional design and analytical
methods, which are biased against Medtronic’s Endeavor stent in favor of Johnson & Johnson’s
Cypher stent. (Read
more...) March 15, 2010
PERSEUS
Trial Results Demonstrate Positive Safety and Efficacy Outcomes for
Boston Scientific's Novel Platinum Chromium TAXUS® Element™ Stent System
Boston Scientific Corporation (NYSE: BSX) today announced 12-month results
from its PERSEUS clinical program that demonstrated positive safety and efficacy
outcomes in workhorse lesions for the platinum chromium TAXUS® Element™ Paclitaxel-Eluting
Stent System compared to the TAXUS® Express2™ Paclitaxel-Eluting Stent System. (Read more...)
March 15, 2010
Abbott Announces Positive
Data From ABSORB Trial on Its Bioresorbable Vascular Scaffold Technology
Abbott today announced positive 30-day results from the first 101 patients
enrolled in the second phase of the ABSORB trial. Patients treated with Abbott's
bioresorbable vascular scaffold (BVS), under clinical investigation in Europe,
demonstrated no cases of blood clots (thrombosis), no need for repeat procedures
(ischemia-driven target lesion revascularization) and a very low rate of major
adverse cardiac events (MACE rate of 2.0 percent) at 30 days. (Read
more...)
March 14, 2010
Endeavor
Stent: 5-Year Data Show Safety and Efficacy Advantage
The presentation at today's American College of Cardiology meeting of the 5-Year
clinical results from ENDEAVOR III, along with the results of Medtronic's (NYSE:
MDT) pooled Endeavor Trials Program, offers what may be a new paradigm for
judging clinical trial results. Especially when taken together with recent
findings from such studies as FAME and ODESSA, angiographic late lumen loss,
one of the standards by which the performance of drug-eluting stents initially
has been judged, may not be as significant a factor as once thought. (Read
more...)
March 14, 2010
Medtronic's Endeavor
Stent Continues to Demonstrate Compelling and Consistent Long-Term
Clinical Results
The consistency and quality of the long-term clinical results for the Endeavor(R)
drug-eluting stent (DES) from Medtronic, Inc. continue to distinguish it as
a treatment for coronary artery disease, according to newly released data.
Five-year findings from the comprehensive ENDEAVOR program were released today
at ACC.10, the American College of Cardiology's 59th Scientific Session. (Read
more...)
March 13, 2010
Medtronic
Starts International Study of CoreValve® Transcatheter Aortic Valve
System
Moving to expand the evidence base for the future of structural heart disease
therapy, Medtronic, Inc. (NYSE: MDT), today announced the start of the first
of several new initiatives in a robust international clinical program for its
CoreValve transcatheter aortic valve system, a minimally-invasive alternative
to open-heart surgery for aortic valve replacement. (Read
more...)
March 13, 2010
Excel
Trial Will Determine Safety and Efficacy of Drug-Eluting Stents vs.
Bypass Surgery in Patients with Left Main Coronary Artery Disease
The announcement of a new clinical trial, EXCEL (Evaluation of Xience Prime
versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization),
that will compare drug-eluting stents to coronary artery bypass graft surgery
in patients with left main coronary artery disease, was made today at “Optimizing
PCI Outcomes: Evolving Paradigms,” a symposium presented by the Cardiovascular
Research Foundation. (Read
more...)
March 12, 2010
FDA
Alert: Plavix May Be Less Effective in Some Patients with Genetic Variation
What some clinicians have known about for some time is now official: the U.S.
Food and Drug Administration today added a boxed warning to the drug Plavix
(clopidogrel) stating that, in some patients with a genetic variation of the
cytochrome CYP2C19, Plavix may not be metabolized properly and therefore may
not be effective for the indicated therapy. (Read
more...)
March 11, 2010
Three Months of Plavix
After Stent: When Less May Be More
When trials are testing 12 and 30 months of Plavix plus aspirin after stenting.
a new study in Brazil is testing whether three months may be enough. Dr. Fausto
Feres discusses his OPTIMIZE trial with Medtronic's Endeavor zotarolimus-eluting
stent. (Read
more...)
March 11, 2010
Interview
with Dr. Fausto Feres: Is Three Months of Antiplatelet Therapy After
the Endeavor Zotarolimus-Eluting Stent Enough?
In this exclusive interview, Dr. Feres explains the novel nature of this 3,000
patient trial which is measuring patient outcomes after only three months of
dual antiplatelet therapy when used with Medtronic's Endeavor ZES. OPTIMIZE
is unique because, due to concerns over late stent thrombosis, other trials
are testing periods of one to three years -- Dr. Feres' hypothesis is that
the Endeavor zotarolimus-eluting stent heals more quickly and therefore patients
do not need to be taking aspirin plus Plavix for more than three months. If
borne out, these finding could have important implications for cost-savings
as well as patient safety. (Read
more...)
February 19, 2010
Plavix After Stents: How
Long?
Commentary from the Editor's Blog: Current guidelines are for a
year or more of dual antiplatelet therapy after drug-eluting stents. But
how did we arrive at that number and what research is currently being done?
Should it be a longer period, or shorter? (Read
more...)
February 16, 2010
Stents
Downgraded by Wall Street Journal: If Only It Were That Simple
A broad-based critique, claiming overuse of heart stents and angioplasty, was
published as a major feature in Thursday's Wall Street Journal. There's no
question that the COURAGE study raised important issues, but the WSJ piece
oversimplifies its implications and leaves out some critically important points. (Read
more...)
February 16, 2010
Interview
with Dr. Eric J. Topol: Optimal Antiplatelet Therapy After Stenting
Commenting on the very large DAPT trial, Dr. Topol says, "The notion that
we should treat all patients for X duration is totally crazy. It completely
goes against all the evidence that every patient is an individual with a
separate biologic story.... I'm amazed that it's going forward." In this
interview, Dr. Topol discusses the work his Institute at Scripps is doing
in genomic studies of platelet responsiveness
and
its implications in determining the
optimal duration of dual antiplatelet therapy. (Read
more...)
February 12, 2010
Clinton
and Eisenhower: Presidents, Hearts, Stents and 55 Years
Commentary from the Editor's Blog: It's
a holiday concurrence: Valentine's Day and President's
Day and American Heart Month -- and former President
Bill Clinton who got his heart fixed six years ago
and just got a "tune-up", is already back home. This
was not the case 55 years ago when Dwight D. Eisenhower
suffered a massive heart attack. (Read
more...)
February 11, 2010
Bill
Clinton Has Angioplasty, Receives Two Stents
Former President Bill Clinton "is in good spirits" and recovering from a
successful angioplasty procedure in which two stents were placed, according
to Clinton spokesman Douglas Band. (Read
more...)
February 10, 2010
Drug-Eluting Stents Safe
and Effective for Treatment of In-Stent Restenosis
From Arezzo, Italy come long-term large registry data demonstrating the successful
use of sirolimus-eluting stents for the treatment of re-occluded bare metal
stents. In the current issue of the Journal of the American College of Cardiology,
Dr. Francesco Liistro and his colleagues at the Ospedale San Donato report
that after four years, the clinical benefit seen at nine months has held steady
with a need to reopen the artery only 11% of the time. (Read
more...)
February 5, 2010
Patent
Spending
Boston Scientific spends almost $2 billion to settle its long-standing patent
issues with Johnson & Johnson. (Read
more...)
February 1, 2010
Boston
Scientific Settles Longstanding Patent Disputes With J&J
Boston Scientific Corporation (NYSE: BSX) announced the settlement of
three patent disputes with Johnson & Johnson (J&J). The disputes date back
to 2003 and cover Boston Scientific's Jang patent and J&J's Palmaz and Gray
patents, all of which involve intellectual property in the cardiovascular arena.
Boston Scientific will make a $1.725 billion payment to J&J in connection with
the settlement. (Read
more...)
January 26, 2010
Approvals
and Acquisitions: Medtronic Continues Expanding Beyond the Coronaries
With the FDA's approval of its Melody Transcatheter Pulmonary Valve, the first
percutaneous valve to be approved in the U.S., and its acquisition of European-based
Invatec, Medtronic is positioning itself to expand its interventional cardiology
portfolio well beyond the coronary arteries. (Read
more...)
January 25, 2010
Stent Manufacturers Donate
Millions To Haiti Earthquake Relief
In the two weeks since a devastating earthquake struck Haiti, the major U.S.-based
stent manufacturers have responded by pledging over three million dollars of
aid for both immediate and long-term relief efforts. (Read
more...)
January 15, 2010
Medtronic
Pledges Over $250,000 to Haiti Earthquake Relief
Medtronic, Inc. (NYSE: MDT) announced today that it has pledged $150,000 through
the Medtronic Foundation to support earthquake relief efforts in Haiti. The
Foundation will match employee donations up to $50,000, with matching funds
directed to Partners in Health. An additional $100,000 grant will be directed
to the rebuilding of community health clinics in Haiti. Employees worldwide
also are offered five days of paid leave to assist in recovery efforts. (Read
more...)
December 8, 2009
Medtronic
Hires Renowned Cardiologist as Vice President of Medical Affairs for
Coronary and Peripheral Business
Medtronic, Inc. (NYSE: MDT), today announced the hire of Prof. Martin Rothman
as vice president of medical affairs for the company’s coronary and peripheral
vascular business. Prof. Rothman will join Medtronic after 37 years of clinical
practice in the U.K. as an interventional cardiologist. He is world renowned
for his contributions to clinical research, training and education, and medical
technology innovation in cardiovascular medicine. (Read
more...)
December 2, 2009
Medtronic Names Michael J.
Coyle as Executive Vice President and Group President of Cardiology Businesses
Medtronic, Inc. (NYSE:MDT), today announced the appointment of Michael
J. Coyle as executive vice president and group president of its Cardiology
businesses. Coyle will lead all aspects of the group, which includes
the company’s Cardiac Rhythm Disease Management (CRDM), CardioVascular
and Physio-Control businesses. He will be a member of the Executive
Committee and report to Chairman and CEO Bill Hawkins. (Read
more...)
November 25, 2009
Medtronic CEO William
Hawkins to Speak at 21st Annual Piper Jaffray Healthcare Conference
Medtronic, Inc. (NYSE: MDT), the world's leading medical technology company,
today announced it will participate in the 21st Annual Piper Jaffray Healthcare
Conference on Tuesday, Dec. 1, 2009, in New York. (Read
more...)
November 24, 2009
Medtronic Second Quarter
Revenue Increases 8% to $3.838 Billion; Raises EPS Guidance for Current
Fiscal Year
"Our solid financial performance this quarter was driven by consistent execution
across our diversified portfolio of businesses," said Bill Hawkins, Medtronic
chairman and chief executive officer. "We are well-positioned to deliver on
our commitments for the balance of our fiscal year and to launch innovative
new products to drive further growth in the coming years." (Read
more...)
November 19, 2009
Medtronic Chairman and
CEO Bill Hawkins Comments on U.S. Senate's Revised Medical Device Industry
Fee Proposal
Medtronic, Inc. (NYSE: MDT), chairman and CEO Bill Hawkins today issued a statement
regarding the U.S. Senate’s revised proposal regarding
a medical device industry fee released yesterday. This new proposal amends
the Senate Finance Committee’s earlier proposed $40 billion fee on the medical
device industry. Senators Amy Klobuchar and Al Franken were instrumental in
reducing the size of the proposal in the Senate. Their efforts will serve to
protect innovation and jobs while advancing meaningful healthcare reform. (Read
more...)
October 13, 2009
Medtronic Starts Study
of Interventional Erectile Dysfunction Therapy
Medtronic, Inc. (NYSE: MDT), announced today the initiation of a feasibility
study of an interventional treatment for erectile dysfunction (ED) that uses
a specially-designed drug-eluting stent system. The study, called ZEN (Zotarolimus-Eluting
Peripheral Stent System for the Treatment of Erectile Dysfunction in Males
with Sub-Optimal Response to PDE5 Inhibitors), is being performed under an
investigational device exemption (IDE) issued by the U.S. Food and Drug Administration
and is expected to enroll a total of 50 subjects at up to ten medical centers
in the United States over the next year. (Read
more...)
September 23, 2009
Abbott's
XIENCE V® Drug-Eluting Stent Superior to Boston Scientific's TAXUS® at
One Year
A new study shows that after one year the second generation XIENCE V drug-eluting
stent from Abbott was more effective in keeping coronary arteries open than
Boston Scientific's older TAXUS stent. In presenting the results of the SPIRIT
IV clinical trial at this morning's session of the TCT 2009 in San Francisco,
principal investigator Dr. Gregg W. Stone stated, "The SPIRIT IV results
show that XIENCE V significantly reduces a patient's risk of experiencing a
heart attack, the need for a repeat procedure or stent thrombosis." (Read
more...)
September 21, 2009
Medtronic’s
Resolute® Drug-Eluting Stent Maintains Strong, Sustained Efficacy
and Safety in Long-Term Follow-Up
New clinical data released today at a major meeting of interventional cardiologists
show strong and sustained efficacy and safety of the Resolute® Zotarolimus-Eluting
Coronary Stent from Medtronic, Inc. (NYSE: MDT) in long-term patient follow-up.
The single-arm RESOLUTE trial (n=129) demonstrates a low, 1.6 percent cumulative
rate of target lesion revascularization (TLR) – or repeat procedures to treat
the previously stented portion of the vessel – with no new TLRs between two
and three years of follow-up. (Read
more...)
September 21, 2009
Endeavor® Stent Reduced
Risk of Heart Attack/Cardiac Death by 48% at Three Years Compared to
Taxus® Stent in Large Study
Three year data for the Endeavor IV study of 1,548 patients announced today
show that when compared to Boston Scientific's Taxus stent, Medtronic's Endeavor
had significantly lower heart attack/cardiac death rates, as well as much lower
late and very late stent thrombosis. (Read
more...)
September 18, 2009
Medtronic Expects New
Data on Drug-Eluting Stents and Transcatheter Heart Valves to Feature
at TCT 2009
Expecting new data on drug-eluting stents and transcatheter heart valves to
feature prominently at Transcatheter Cardiovascular Therapeutics (TCT) 2009
next week in San Francisco, Medtronic, Inc. (NYSE: MDT), today announced plans
to showcase its innovative cardiovascular product portfolio, technology pipeline
and clinical research at the world’s premier annual meeting for interventional
cardiologists. (Read
more...)
September 15, 2009
Drug-Eluting Stent Summit
Announced for TCT 2009 Meeting in San Francisco
Over 16 hours of presentations on drug-eluting stents will kick off next week's
TCT meeting, billed as the largest global medical and scientific symposium
dedicated to interventional cardiovascular medicine. The annual week-long meeting
is being held at the Moscone Center in San Francisco this year, and will return
to its regular venue in Washington DC in 2010. (Read
more...)
September 15, 2009
Drug-Eluting
Stents: Looking Ahead
From The Editor's Blog: During the first
two days (September 21-22) of this year's TCT, the meeting will be hosting
the "DES
Summit" --
more than 16 hours of presentations -- over 100 separate short talks on every
aspect of drug-eluting stents, from safety to antiplatelet therapy to biodegradable
stents to drug-eluting balloons and the use of these devices in patients
from stable to STEMI (heart attack). (Read
more...)
August 22, 2009
Drug-Eluting
Stents: Looking Back
From The Editor's Blog: This past month has offered an odd bit of reminiscence
about an object of ongoing interest: the drug-eluting stent (DES). First a
study
from
Duke
was
published in Circulation: Cardiovascular Quality and Outcomes and it detailed
the Fall of the drug-eluting stent -- a.k.a. the Fall of 2006, when various
studies about increased risk of blood clotting (a.k.a. Late Stent Thrombosis)
in drug-eluting stents after six months were presented at the European Society
of Cardiology meeting (a.k.a. the "DES firestorm"). (Read
more...)
August 21, 2009
Interview
with David E. Kandzari, MD
Dr. David E. Kandzari is Director of Interventional Cardiology Research at
Scripps Clinic in La Jolla, California. His career in interventional cardiology
has been unique in that he has had the opportunity to be involved in drug-eluting
stent issues from multiple perspectives: academic, clinical, regulatory and
industry. In this exclusive interview, Dr. Kandzari shares his thoughts on
the current status of drug-eluting stents and the outstanding safety and clinical
issues. (Read
more...)
August 19, 2009
FALSE:
Stents Denied to Patients Over 59
A false meme has been circulating that the British National Health Service
(NHS) denies stents to patients older than 59...and that Obama's health care
reform will follow the NHS guidelines. Totally wrong! This lie has been circulated
worldwide in an anonymous email and somehow has found its way into articles,
op-ed pieces, etc. and is clearly part of an organized
campaign to scare elderly citizens into opposing health care reform. (Read
more...)
August 14, 2009
Medtronic
to Announce Financial Results for Its First Fiscal Quarter
Medtronic, Inc. (NYSE: MDT), announced today it will report financial results
for its first fiscal quarter on Tuesday, August 25, 2009. The earnings news
release will include summary financial information for Medtronic’s first quarter ended July 31, 2009. (Read
more...)
August 6, 2009
Medtronic
Awarded $57 Million in Patent Dispute with AGA Medical Corporation
Medtronic, Inc. (NYSE: MDT), announced today that a federal U.S. district court
jury in San Francisco awarded it $57 million in past damages, finding that
AGA Medical Corp.’s manufacture, sale and use of its Amplatzer® Occluder and
vascular plug product lines infringed claims of two U.S. patents owned by Medtronic.
The jury also ordered that AGA pay Medtronic a royalty of 11% on future U.S.
sales of the infringing products through 2018. (Read
more...)
July 27, 2009
Medtronic
and Abbott Laboratories Resolve Global Vascular Patent Disputes
Medtronic, Inc. (NYSE:MDT) today announced global resolution of all outstanding
intellectual property litigation with Abbott Laboratories. Terms of the agreement
stipulate that neither party will sue each other in the field of coronary stent
and stent delivery systems for a period of at least 10 years, subject to certain
conditions. (Read
more...)
July 10, 2009
Prasugrel
/ Effient Approved by FDA
After a year-and-a-half of review, amid concerns over potentially serious bleeding
complications, the FDA today approved Eli Lilly's blood thinner Prasugrel (it
will be marketed in the U.S. as Effient). (Read
more...)
July 5, 2009
Stents:
An Insider's Look
From the Editor's Blog: I recently talked at length with Dr. Giulio Guagliumi
of Bergamo, Italy about his extensive work with one of the newest intravascular
imaging modalities that looks inside the coronary artery: Optical Coherence
Tomography, or OCT. He's been using the light-based technique to examine implanted
stents and determine whether or not healing has occurred; that is, whether
the stent struts have been covered over by a layer of endothelial cells. (Read
more...)
July 5, 2009
Interview
with Giulio Guagliumi, MD About Optical Coherence Tomography and Stents
Dr. Giulio Guagliumi, an internationally recognized leader in the use of Optical
Coherence Tomography (OCT) in the coronary arteries, practices in the Cardiovascular
Department of Ospedali Riuniti di Bergamo in Bergamo, Italy. Dr. Guagliumi
has been published in numerous peer-reviewed journals and is principal investigator
in several clinical trials assessing the performance of stents inside the coronary
artery, using OCT imaging. In this interview, he discusses the dynamic changes
occurring with this technology. (Read
more...)
May 19, 2009
Endeavor
Drug-Eluting Stent Is First to Receive CE Mark for Treating Acute Coronary
Syndrome
Medtronic, Inc. (NYSE: MDT), today announced that its Endeavor drug-eluting
stent (DES) is the first and only coronary stent to have received CE (Conformité Européene)
Mark approval for treating patients with acute coronary syndrome (ACS), which
includes unstable angina and acute myocardial infarction (AMI), commonly known
as heart attack. (Read
more...)
May 19, 2009
New Data From ENDEAVOR-II
Challenges Conventional Wisdom on Drug-Eluting Stents
In ENDEAVOR-II (n=1,197), a randomized controlled trial comparing Medtronic’s
Endeavor drug-eluting stent (DES) to its Driver bare-metal stent
(BMS), patients treated with the Endeavor DES required fewer repeat procedures
at five years post-implant than many observers and analysts would have expected
based on the results of other trials with comparable designs. With clinical
data from ENDEAVOR-II now through five years of follow-up, the Endeavor DES
continues to show a distinctively low and durable plateau in the rate of target
lesion revascularization (TLR), a standard measure of efficacy for coronary
stents. (Read more...)
May 19, 2009
New
Intravascular Ultrasound (IVUS) Study of Underexpanded Stents, Thrombosis
and Restenosis
A study, published in the current issue of JACC Interventions, details 120
drug-eluting stent cases as viewed by intravascular ultrasound (IVUS) in order
to examine characteristics that may lead to in-stent restenosis (ISR) or stent
thrombosis. The researchers found that in cases of thrombosis, the proximal
parts of many of the stents were inadequately expanded. An accompanying editorial
suggests greater use of IVUS and more attention to detail can reduce the number
of these adverse clinical events. (Read
more...)
May 18, 2009
Medtronic
to Participate in the Piper Jaffray Post-EuroPCR Summit
Medtronic, Inc. (NYSE: MDT) today announced it will participate in the Piper
Jaffray PCR Post-Op Summit on Friday, May 22, 2009, in London. Scott R. Ward
Scott Ward, President, CardioVascular Medtronic Scott Ward, president of the
CardioVascular business and senior vice president at Medtronic, will speak
to the attendees of the conference at 8 a.m. British Summer Time (2 a.m. Central
Daylight Time). (Read
more...)
May 16, 2009
Innovative Stent Manufacturer
XTENT Plans To Close Business After Failing to Find Buyer
XTENT (Nasdaq: XTNT), maker of an innovative stent that received the European
CE Mark just two months ago, is closing its doors after failing to find a
partner or buyer, a goal first announced in January. The Company's Board
of Directors voted yesterday that "it
is in the best interests of the Company and its stockholders to liquidate
the Company's assets and to dissolve the Company." The plan is
subject to stockholder approval. (Read
more...) May 15, 2009
New
Data on Endeavor Stent's Long-Term Safety and Efficacy to Be Featured
at Interventional Cardiology Congress
Medtronic, Inc. (NYSE: MDT), today announced planned highlights of new data
presentations scheduled for the 2009 PCR meeting that feature the company’s
cardiovascular innovations. From late breaking clinical trials, extensive new
data on the Endeavor® Drug-Eluting Stent (DES) will be presented, which shows
unprecedented long-term efficacy for a DES. (Read
more...)
May 14, 2009
Medtronic Completes
Enrollment in International Post-Market Study of Resolute Drug-Eluting
Stent
Medtronic, Inc. (NYSE: MDT), today announced completion of enrollment in RESOLUTE
International, a post-market study of its Resolute Drug-Eluting Stent (DES).
One-year data from this international study, which enrolled 2,464 patients
at 88 sites from 17 countries in Europe, Asia, Africa, and Latin America, are
expected in the second half of 2010. (Read
more...)
May 6, 2009
Heartburn
Drugs Increase Cardiac Events for Stent Patients by 50%
Most stent patients are required to take the antiplatelet drug clopidogrel
(Plavix) for at least a year to prevent blood clots inside the stent. A new
study, presented today at the Society for Cardiovascular Angiography and Interventions
(SCAI) 32nd Annual Scientific Sessions, showed that the beneficial effects
of Plavix are compromised by common drugs, used for the treatment of heartburn
and ulcers: the combined risk of hospitalization for heart attack, stroke and
other serious cardiovascular illnesses was increased by 50%. (Read
more...)
May 4, 2009
Effectiveness
in Stenting
As Volcano's CEO Scott Huennekens writes in an op-ed piece, there's a whole
toolbox of devices and techniques that are candidates for "comparative effectiveness" in
that they may be able to increase the success of interventional procedures
-- or even target patients who need these procedures more accurately. (Read
more...)
April 27, 2009
Medtronic
Starts Enrollment in THRIVE, U.S. Post-Market Study of the Talent™ Thoracic
Stent Graft
Medtronic, Inc. (NYSE: MDT), today reported the start of THRIVE, the company's
U.S. post-market clinical study of its Talent Thoracic Stent Graft for the
endovascular repair of thoracic aortic aneurysms. (Read
more...)
April 8, 2009
Medtronic's
Endeavor Stent Reduces Occlusion of Small Arterial Side Branches by
50%
A new study, published online before print in Circulation: Cardiovascular Interventions,
concludes that "Patients treated with ZES [Medtronic's Endeavor Zotarolimus
Eluting Stent] were less likely to develop sidebranch occlusion during stent
placement than patients treated with PES [Boston Scientific's Taxus Express
Paclitaxel Eluting Stent]. (Read
more...)
April 3, 2009
Medtronic
Launches Driver Sprint RX Coronary Stent System Worldwide
Medtronic, Inc. (NYSE: MDT) announced earlier this week that it has begun the
international launch of its Driver Sprint RX Coronary Stent System, which received
the CE (Conformité Européene) Mark in February 2009. The company plans to have
its bare-metal stent on a rapid exchange platform commercially available in
more than 100 countries worldwide. “The Driver stent system has always been
very deliverable,” explained leading stent researcher Dr. C. Dubois of Leuven
University Hospital in Belgium. “Now, the new Driver Sprint system makes it
even more deliverable for the most challenging anatomy.” (Read
more...)
March 30, 2009
Medtronic's
Endeavor® Drug-Eluting Coronary Stent Approved in Japan
Medtronic, Inc. (NYSE: MDT), today announced approval of its Endeavor drug-eluting
coronary stent system by the Japanese Ministry of Health, Labor and Welfare
(MHLW), clearing the way for the highly anticipated launch of the product in
the world’s second largest market for advanced medical technology. Medtronic
plans to launch the Endeavor drug-eluting stent (DES) immediately following
the authorization of reimbursement which is expected on May 1, making the
Endeavor DES commercially available in every major market in the world. (Read
more...)
March 29, 2009
Abbott's
Market-Leading XIENCE V® Shows Increasing Clinical Advantages Over
TAXUS® Express2™/TAXUS® Liberte™ Between Two and Three Years
Long-term data presented today from Abbott’s SPIRIT II clinical trial demonstrated
that the clinical advantages of the XIENCE V® Everolimus Eluting Coronary Stent
System continued to increase between two and three years compared to the TAXUS® Express2™ Paclitaxel-Eluting
Coronary Stent System / TAXUS® Liberte™ Paclitaxel-Eluting Coronary Stent System
(TAXUS). (Read
more...)
March 29, 2009
ZEST:
3 Stents Go Head-to-Head-to-Head
The results of ZEST, a large scale randomized multi-center trial of all comers
were presented this morning to the i2 Summit at ACC.09 by Dr. Seung-Jung Park
of Asan Medical Center in South Korea. The goal of the trial was to evaluate
paclitaxel- and sirolimus-eluting stents compared with zotarolimus-eluting
stents in patients with coronary artery disease. (Read
more...)
March 29, 2009
Small
Trial for Innovative 'Healing' Stent Contradicts Findings from Larger
Studies
Cardiologists anticipating positive results from a small head-to-head study
comparing the novel Genous 'pro-healing' stent to a third generation bare metal
chromium-cobalt stent were disappointed yesterday by less than favorable data
from the 100-patient GENIUS-STEMI study. The MACE rate was 24% for the Genous
vs. 10% for the bare metal stent. TLR was 14% vs. 4%. Not only were these rates
very high, but they were far different from data that has been presented in
the initial clinical trials for the Genous, as well as a very large 5,000-patient
observational study, called the e-Healing Registry. (Read
more...)
March 28, 2009
Two-Year Data for Medtronic
Drug-Eluting Stent Shows Continued Safety and Effectiveness
Two-year results for more than 2,000 patients in the international,
E-Five study of Medtronic's Endeavor Zotarolimus-eluting Stent
show that the stent was associated with a low rate of both overall
(0.7
percent) and very
late
stent
thrombosis (VLAST) at 0.1 percent. (Read
more...)
March 28, 2009
Stents:
Same Outcomes, Less Money Than Surgery for Many Heart Patients
For many patients with triple-vessel or left main disease, drug-eluting stents
provide similar outcomes to bypass surgery -- and for less money, according
to data from the SYNTAX trial, presented this morning to the i2 Summit at the
American College of Cardiology's 58th annual scientific session. (Read
more...)
March 27, 2009
Medtronic
Announces ACC 2009 Presentations
Medtronic, Inc. (NYSE: MDT), today announced highlights of clinical data presentations
scheduled for the 2009 American College of Cardiology (ACC) meeting that feature
the company’s cardiovascular innovations, including the Endeavor Drug-Eluting
Stent (DES) and the Export Aspiration Catheter. ACC.09 takes place in Orlando
March 28–31 at the Orange County Convention Center. (Read
more...)
March 26, 2009
Boston
Scientific Announces ACC 2009 Schedule
Boston Scientific Corporation today announced the schedule of the Company's
major events and news announcements at the 58th Annual Scientific Session of
the American College of Cardiology / i2 Summit, which runs from March 28-31
in Orlando, Florida. (Read
more...)
March 26, 2009
Cordis
Celebrates 50 Years of Transforming Cardiovascular Care
As cardiologists are arriving in Orlando for the beginning of this weekend's
58th Annual Scientific Sessions of the American College of Cardiology, just
a few hours away, Cordis Corporation will be celebrating its 50th anniversary
as a manufacturer of innovative medical devices. (Read
more...)
March 24, 2009
Is
The Scaffolding Coming Down?
From the Editor's Blog -- Today's good news about Abbott's bioabsorbable stent
brings the following analogy to mind: scaffolding. Unfortunately scaffolding
inside the artery, unlike its building construction counterpart, cannot be
removed once its job is done. (Read
more...)
March 24, 2009
Abbott Moves Forward with
Bioabsorbable Stent
Following recent publication of the two-year results of the ABSORB clinical
trial of its novel bioabsorbable drug-eluting stent, Abbott Vascular today
announced the start of the next phase of the trial, set to enroll 80 additional
patients. Article contains an exclusive video of Dr. Charles Simonton, Chief
Medical Officer for Abbott Vascular. (Read
more...)
March 20, 2009
XTENT's
Customizable Drug-Eluting Stent Gets European CE Mark Approval
Hopefully, for the innovative stent manufactured by XTENT, Inc. (Nasdaq: XTNT),
yesterday's European approval has not come too late. On Thursday, the company
announced that it has received CE Mark approval for its CUSTOM NX drug-eluting
stent (DES) System. (Read
more...)
February 17, 2009
Medtronic
Reports Third Quarter Revenue of $3.5 Billion
The company reported third quarter revenue of $3.494 billion, a three percent
increase over third quarter revenue reported in fiscal year 2008 or a six percent
increase after adjusting for an unfavorable $110 million foreign exchange impact. (Read
more...)
February 3, 2009
Boston
Scientific Begins Clinical Trial Enrollment for New Everolimus-Eluting
Stent
The PLATINUM clinical program will enroll 1,728 patients at 160 sites worldwide.
The trial will compare the PROMUS™ Element™ Everolimus-Eluting
Coronary Stent to the PROMUS Everolimus-Eluting Coronary Stent. The Company
plans to
develop additional variations of the Element Stent platform, including next
generations of a bare-metal stent and a paclitaxel-eluting TAXUS® Element
Stent. (Read
more...)
January 28, 2009
Circulation
Publishes Pivotal Two-Year Results On XIENCE V™ Drug
Eluting Stent
Data published online today in Circulation from the SPIRIT
III U.S. pivotal trial evaluating the XIENCE V™ Everolimus Eluting Coronary Stent
System demonstrated that Abbott's market-leading XIENCE V outperforms the TAXUS® Express²™ Paclitaxel-Eluting
Coronary Stent System (TAXUS) in reducing major adverse cardiac events (MACE)
at two years. (Read
more...)
January 28, 2009
TAXUS® Liberte® Drug-Eluting Stent System Approved in Japan
Japan has now approved its first second-generation drug-eluting stent, and
that honor goes to Boston Scientific's TAXUS Liberte Paclitaxel-Eluting Coronary
Stent System. The company announced today that it has received approval from
the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the stent. (Read
more...)
January 25, 2009
Medtronic
Seeks Runners -- Stents Included
Medtronic (NYSE: MDT) recently announced that it is looking for runners from
around the world who have benefited from medical technology to participate
in the company's 4th Annual Medtronic Global Heroes program. Stent patients
are included. The deadline for entry is March 31, 2009. (Read
more...)
January 25, 2009
Study:
CT Scans and Stents Successful in Treating Strokes
Emergency use of CT scans and stents may be able to treat and significantly
reduce the symptoms of a stroke. That is the conclusion of a small 16-patient
study presented this week by Dr. L. Nelson "Nick" Hopkins of the University
at Buffalo, SUNY. The data, presented at the 21st Annual International Symposium
on Endovascular Therapy (ISET), showed that stents were able to open blocked
brain arteries in all of the patients, and that 11 patients (69 percent) had
significant improvement in their stroke symptoms. (Read
more...)
January 23, 2009
Economy
Claims Innovative Xtent
In an announcement today, Xtent Inc. (NASDAQ: XTNT) located in Menlo Park,
California, stated that it is engaging the services of an investment bank to
help the company pursue strategic alternatives, possible sale of some or all
of the company's assets, or other type of acquisition. And of it 121 employees,
all but nine have received termination notices, effective March 23. (Read
more...)
January 21, 2009
XIENCE
V™ Stent Takes the Lead
In sharp contrast to the current gloomy picture in the healthcare sector, Abbott
reported this morning that its 4th quarter 2008 global sales rose 10.1% over
2007, and that the company's XIENCE V drug-eluting stent was a significant
contributor to the bottom line. (Read
more...)
January 19, 2009
When
Less is More: Stents, That Is
So many news reports about the recent FAME study in the New England Journal
of Medicine drive home a message that is not exactly correct. The "Stents
May Be Overused" headline is misleading. And here's why. (Read
more...)
January 13, 2009
Dreadlines
About Stents Revisited
How can a mere article in the "newspaper of record" be dangerous? Is the pen
mightier than the catheter? Is there such a thing as a "killer journalist"? (Read
more...)
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