CoreValve, S.A. demande l'approbation d'IRB en vue du premier implant humain au monde de sa " valvule cardiaque auto-dilatable à tuteur "
( BW) Presse Economique / Santé / Médicale
PARIS--(BUSINESS WIRE)--May 19, 2004--
L'appareil pionnier ReValving(TM) de CoreValve constituera une alternative privilégiée pour la chirurgie à coeur ouvert.
La société dévoilera pour la première fois son appareil breveté lors du congrès cardiovasculaire EuroPCR qui se tiendra du 25 au 28 mai 2004 à Paris, sur le stand N1 IET du Hall Neuilly.
( BW)(COREVALVE) CoreValve, S.A. Seeks IRB Approval for World's First
Human Implantation of Its 'Self-Expanding Stented Heart Valve'
Business Editors/Health/Medical Writers
PARIS--(BUSINESS WIRE)--May 19, 2004--
CoreValve's Breakthrough ReValving(TM) Device Will Provide
Preferred Alternative to Open-Heart Surgery
Company to Show Its Patented Device for the First Time at
"EuroPCR" Cardiovascular Congress in Paris, May 25-28, 2004: Exhibit
"N1 IET" in Neuilly Hall
CoreValve, S.A., an emerging and privately held medical technology
company, announced today that it is seeking Institutional Review Board
(IRB) approval from two undisclosed medical institutions related to
its proprietary and revolutionary self-expanding stented heart valve,
to be implanted in a human, for the first time, using the CoreValve
Percutaneous ReValving(TM) System in a cardiac catheterization
("cath") laboratory.
It is expected that the patient selected will be able to avoid
open-heart surgery to treat aortic stenosis, a narrowing of the heart
valve. The first-of-its-kind procedure on a human is expected to be
performed next month.
"We believe CoreValve is redefining the way heart valve
replacement will be performed in the future," said Dr. Jacques Seguin,
chairman and co-founder of CoreValve. "We look forward to unveiling
our technology at EuroPCR next week."
Aortic stenosis is a narrowing of the heart valve that causes the
heart to work very hard in order to eject blood from the ventricle,
resulting in shortness of breath and, in advanced cases, in fainting
and heart failure. Today, symptomatic patients are typically treated
by open-heart surgery. More than 300,000 patients every year have
surgery on their heart valves. Sixty percent of valve replacement
surgeries are for the aortic valve.
About CoreValve, S.A.
Privately held CoreValve, headquartered in Paris, has developed a
universal system for percutaneously replacing a defective aortic
valve, based on a catheter delivery system and self-expanding-stent
approach on a beating heart, thus avoiding open-heart surgery. The
CoreValve Percutaneous ReValving(TM) System can be adapted to any
biological valves currently marketed or synthetic valves when
approved. The CoreValve procedure can be performed in a cardiac "cath
lab" just like angioplasty and stenting, resulting in less trauma to
the patient and substantial cost-savings to the healthcare system.
This news release contains certain "forward-looking" statements,
which are based on management's current expectations and involve risks
and uncertainties that could cause actual results or outcomes to
differ materially from those contemplated by the forward-looking
statements. Factors that could cause or contribute to such differences
may include, but are not limited to, risks relating to the protection
of intellectual property, changes to governmental regulation of
medical devices, the regulatory approval of new products, the impact
of competitive products, changes to the competitive environment, the
acceptance of new products in the market, conditions of the
interventional cardiology industry and other factors.
CONTACT:
Ronald Trahan Associates Inc.
Ronald C. Trahan, 781-762-9782, x18
KEYWORD: FRANCE INTERNATIONAL EUROPE
INDUSTRY KEYWORD: BANKING MEDICAL DEVICES MEDICAL BIOTECHNOLOGY
SOURCE: C, S.A.
ESHEET: 4644396
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