Tous Actualités
Suivre
Abonner Cordis Medizinische Apparate GmbH

Cordis Medizinische Apparate GmbH

NEVO(TM) Sirolimus-Eluting Coronary Stent Continues to Demonstrate Excellent Safety and Efficacy Outcomes in New Twelve-Month Data

Paris, May 25, 2010 (ots/PRNewswire)

At 12 months the NEVO(TM)
Sirolimus-eluting Coronary Stent has continued to demonstrate
excellent safety and efficacy outcomes compared to Taxus(R)
Liberte(R) according to new data presented today from the NEVO(TM)
RES-I clinical trial. These results were presented as a late breaking
trial at EuroPCR, the leading medical conference in Europe for
physicians specializing in interventional cardiovascular medicine.
Through 12-month follow-up, there have been no episodes of stent
thrombosis reported in the NEVO(TM) arm, whereas two such events have
been reported through 12 months in patients treated with the Taxus(R)
Liberte(R) stent, and a third event in this arm was reported after 13
months. Additionally there have been no cases of cardiac death or
out-of-hospital myocardial infarction (MI) for patients receiving
NEVO(TM).
While the trial was not powered for clinical endpoints and thus
no statistically-significant differences were observed, the rates of
death, MI, the need for repeat revascularization, and the occurrence
of stent thrombosis numerically favored NEVO(TM) over Taxus(R)
Liberte(R) to an even greater degree at 12 months than they had at
six months. Similar trends were observed in the pre-defined subgroups
of patients with diabetes and patients with lesion lengths less than
or greater than 20 mm.
At the six-month primary endpoint of this prospective, randomized
clinical trial, NEVO(TM) was reported to be superior to Taxus(R)
Liberte(R) in in-stent late lumen loss, which is tissue growth within
a stent. Specifically, in-stent late lumen loss was reduced by 64
percent in the NEVO(TM) arm as compared to the Taxus(R) Liberte(R)
arm (0.13 mm compared to 0.36 mm, p<0.001).In-stent late lumen loss
reduces the diameter of the lumen thus restricting blood flow through
the stent and can potentially lead to major adverse coronary events,
also known as MACE. NEVO(TM) was also superior in reducing
restenosis, a reblockage in a stent. Angiographic restenosis was
reduced 86 percent (1.1 percent in the NEVO arm compared to 7.8
percent in the Taxus Liberte arm, p=0.002).
"These data suggest we may be looking at a significant advance in
treatment options for coronary disease that allows precise
stent-based delivery of drug and is capable of reducing long-term
safety complications," said Alexandre Abizaid, MD, the chief of
coronary interventions at the Institute Dante Pazzanese of
Cardiology, Sao Paulo, Brazil and visiting professor of medicine at
Columbia University, New York, USA. "Since stent thrombosis and the
drugs required to protect against it are such significant clinical
issues, it is particularly pleasing to see the excellent safety
outcomes associated with NEVO(TM) maintained over 12 months. These
results also suggest the need for further study of whether
abbreviating or interrupting antiplatelet therapy with this treatment
would result in fewer adverse events than would currently be expected
in drug-eluting stent patients."
"The additional positive 12-month results from the NEVO(TM) RES-I
trial are extremely encouraging as they suggest that NEVO(TM) could
offer improved patient outcomes in the treatment of coronary artery
disease," said Campbell Rogers, M.D., Chief Scientific Officer and
Global Head, Research and Development, Cordis Corporation. "NEVO(TM)
is a critical component of our commitment to providing innovative new
products, which are transforming expectations for patients and
practitioners in the field of interventional cardiology."
NEVO RES-I Study Overview
The NEVO(TM) RES-I study was a randomized, multi-center
comparison of NEVO(TM) to the Taxus(R) Liberte(R) Stent in de novo,
native coronary artery lesions. The study involved 394 patients at 40
sites throughout Europe, South America, Australia and New Zealand.
Patients underwent angiographic follow-up at six months, received
clinical follow-up at 30 days and six and 12 months, and will be
followed annually for the next five years. The primary endpoint was
in-stent late loss at six months. Key secondary endpoints include
target lesion failure, target vessel failure, MACE, stent thrombosis,
target lesion revascularization, target vessel revascularization, and
angiographic in-stent and in-segment binary restenosis at six months.
About NEVO(TM)
NEVO(TM), the first sirolimus-eluting stent utilizing RES
TECHNOLOGY(TM), is an open cell, thin strut, cobalt chromium design
that incorporates hundreds of small reservoirs filled with a recessed
drug-polymer matrix. This is designed to minimize polymer contact
with the vessel wall at implant, and allow transformation from a drug
eluting stent into a bare metal stent in as little as 90 days.
Currently available drug-eluting stents have surfaces completely
coated in drug and a permanent polymer. Cordis submitted NEVO(TM) for
CE-marking in March 2010.
The NEVO(TM) Sirolimus-eluting Coronary Stent is an
investigational device. It is not approved or available for sale in
any market.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson & Johnson
company, has been a worldwide leader in the development and
manufacture of interventional vascular technology. Through the
company's innovation, research and development, Cordis partners with
interventional cardiologists worldwide to treat millions of patients
who suffer from vascular disease.
In addition to his role as Primary Investigator, Dr. Abizaid is
compensated for his services as a member of the Company's scientific
advisory board and provides other consulting services.
*Cordis Corporation has entered into an exclusive worldwide
license with Wyeth for the localized delivery of sirolimus in certain
fields of use, including delivery via vascular stenting. Sirolimus,
the active drug released for the stent, is marketed by Wyeth
Pharmaceuticals, a division of Wyeth, under the name Rapamune(R).
Rapamune is a trademark of Wyeth Pharmaceuticals.
The third party trademarks used herein are trademarks of their
respective owners
Image: NEVO(TM) Sirolimus-eluting Coronary Stent
NOTE: Disclaimer needs to be used and placed next to image if you
plan to  publish:
"NEVO(TM) Sirolimus-eluting Coronary Stent is an investigational
device exclusively for clinical investigations and is not approved
for sale in any market"
Subtitle image: NEVO(TM), the first drug-eluting stent utilizing
RES  TECHNOLOGY(TM), incorporates hundreds of small reservoirs filled
with a  recessed drug-polymer matrix.
Contact:
    Ulrike Domany
    Director Communication & Public Affairs, EMEA
    Mobile: +43-664-83-504-83
    Office: +43-360-25-396

Contact:

CONTACT: Contact: Ulrike Domany, Director Communication & Public
Affairs,EMEA, Mobile: +43-664-83-504-83, Office: +43-360-25-396; A.J.
Desjardins,Edelman, Mobile: +33-6-29-56-06-52, Office:
+33-1-56-69-73-99

Plus de actualités: Cordis Medizinische Apparate GmbH
Plus de actualités: Cordis Medizinische Apparate GmbH
  • 26.09.2006 – 09:05

    Cordis Corporation Launches CYPHER SELECT(TM) Plus Stent

    Paris (ots/PRNewswire) - - Shipment of First Third-Generation Drug-eluting Stent Starts Cordis Corporation, the world leader in the drug-eluting stent market, announced today the launch of the CYPHER SELECT(TM) Plus Stent. The first third-generation drug-eluting stent is now available to physicians and patients in many markets around the world, including countries in Western and Eastern Europe, Asia Pacific ...

  • 09.06.2005 – 17:08

    Cordis Corporation to Appeal Court Ruling

    Miami (ots/PRNewswire) - Cordis Corporation, a Johnson & Johnson company, today received a ruling from a court in the Netherlands that found the company infringed a Boston Scientific patent related to a catheter shaft that is used in the delivery system for the CYPHER(R) and CYPHER(R) Select Sirolimus-eluting Coronary Stents, as well as several other catheter-based products. Cordis intends to file an appeal with the ...