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100th Patient Successfully Treated Using CoreValve's ReValving(TM) Device to Non-Surgically Replace a Diseased Aortic Heart Valve.


Third-generation, 18-French-sized ReValving System, with greater ease of implantation and suitability for wider number of patients, is being adopted quickly by interventional cardiologists who are participating in the ongoing international clinical trial of ReValving

"This 100(th) successful case represents a momentous occasion for CoreValve when one considers that there have been no device-related deaths and no device failures during implantation and at up to 22 months of follow-up to date. But what should not be overlooked is that all these patients would have otherwise been left untreated, many of them facing imminent death, because they were too frail for the only other treatment alternative: open-heart surgery open-heart surgery

Any surgical procedure opening the heart and exposing one or more of its chambers, most often to repair valve disease or correct congenital heart malformations (see congenital heart disease).
."

Jacques S[c]guin, MD, PhD, Chairman, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  and Founder, CoreValve

IRVINE, Calif. -- CoreValve (www.corevalve.com) announced today that a total of 100 patients at nine worldwide investigative sites have now undergone percutaneous aortic valve replacement In percutaneous aortic valve replacement (PAVR), a synthetic valve is transported to the heart through a small hole made in groin. This procedure can be compared to that performed when placing a stent, or performing balloon angioplasty.  (PAVR) on a beating heart with the CoreValve Percutaneous ReValving[TM] System to treat either their aortic stenosis aortic stenosis
n. Abbr. AS
Pathological narrowing of the orifice of the aortic valve.


Aortic stenosis
A stiffening of the artery which carries blood from the heart to the body.
, aortic regurgitation aortic regurgitation
n.
Incompetence of the aortic valve of the heart, resulting in backward flow of blood. Also called aortic insufficiency.
, or failed-tissue-valve-prosthesis conditions.

"It is important to note that these patients are able to realize a substantially improved quality-of-life at follow-up now out to nearly two years in some cases," said Jacques S[c]guin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve. "The 100th ReValving patient also represents the 21st patient who has undergone the ReValving procedure with our third-generation device, and the ease of implantation of the 18-French delivery catheter is fast-forwarding adoption by the interventionalists who participate in the ongoing clinical trial of ReValving. Because the reduced-size delivery catheter allows access in patients with smaller or more diseased arteries, a much wider range of patients can undergo the ReValving procedureaall high-risk patients who are contraindicated for the only other active-treatment alternative: open-heart surgery."

Added Rob Michiels, President and Chief Operating Officer Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
 of CoreValve: "In light of our recent announcements about the 18-French ReValving procedure being performed not only in a purely percutaneous manner (no surgical cut-down) but also without the use of extracorporeal extracorporeal /ex·tra·cor·po·re·al/ (-kor-por´e-al) situated or occurring outside the body.

ex·tra·cor·po·re·al
adj.
Situated or occurring outside the body.
 bypass, other cardiac assistance or even rapid pacing, our clinical investigators are rapidly moving ReValving toward a less complex and nearly standard cath lab A catheterization laboratory or cath lab is an examination room in a hospital or clinic with diagnostic imaging equipment to support the catheterization procedure. A catheter is inserted into a large artery, and various wires and devices can be inserted through the body via  procedure. These technical and clinical achievements bolster our belief that ReValving is positioned to become an alternative to open-heart surgery in the future."

About CoreValve

Founded in 2001, privately held CoreValveawhich is headquartered in Irvine, Californiaahas developed a proprietary delivery system for percutaneous heart valve replacement Heart Valve Replacement Definition

Heart valve replacement is a surgical procedure during which surgeons remove a damaged valve from the heart and substitute a healthy one.
, based on a novel catheter-and-self-expanding-frame approach on a beating heart, thus avoiding open-heart surgery. The CoreValve procedureawith the proprietary CoreValve Percutaneous ReValving[TM] Systemacan 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. For more information about CoreValve, visit the Company's Web site at www.corevalve.com.

Forward-Looking Statements

This news release contains certain "forward-looking" statements under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. These "forward-looking" statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of CoreValve, are based on management's current expectations and estimates 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 relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 the protection of intellectual property, changes to governmental regulation of medical devices, the FDA's 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 interventional cardiology Cardiology The subspecialty of cardiology dedicated to the diagnosis, medical and mechanical therapy, pre- and post-procedure management of adult patients with acute and chronic forms of cardiovascular disease amenable to catheter-based  industry and the economy and other factors.

(Caution: the CoreValve ReValving[TM] System will not be available in the USA for clinical trials or for commercialization until further notice. Non-USA clinical investigations are in progress. Not available for sale.)
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Nov 21, 2006
Words:637
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