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Second European Clinical Site Uses CoreValve's Novel ReValving(TM) System to Non-Surgically Replace Diseased Aortic Heart Valve of 77-Year-Old Female Patient Who Was Not Eligible for Open-Heart Surgery.


IRVINE, Calif., & PARIS Paris, in Greek mythology
Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt.
 -- CoreValve

"The successful completion of CoreValve's feasibility trials at Siegburg Heart Center (Germany) has validated the desirability of initiating learning-curve cases at additional 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  centers. Rotterdam's prestigious Erasmus Thoraxcenter was a logical first candidate for our expanding clinical trial."

--Jacques Seguin, 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

CoreValve (www.corevalve.com) announced today that standard follow-up testing, conducted several days after a percutaneous ReValving(TM) procedure was performed in a second European clinical site to replace a patient's defective aortic aortic

pertaining to or emanating from the aorta. See also aortic arch.


aortic aneurysm
occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing.
 heart valve, showed perfect functioning and anchoring of the new biological heart valve. Because of ReValving, the 77-year-old high-surgical-risk female patient was able to avoid 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).
. The successful procedure was performed by Professor Patrick W. Serruys, a globally recognized interventional cardiologist who has been a leading investigator in clinical trials of numerous cutting-edge technologies, and Dr. Peter DeJaegere at Erasmus University Medical Center, Rotterdam, the Netherlands; they were assisted by Dr. Jean-Claude Laborde, an interventional cardiologist at Clinique Pasteur, Toulouse, France, who has had extensive clinical experience with the CoreValve Percutaneous ReValving System(TM).

"I was pleasantly surprised at the ease of use of the CoreValve Percutaneous ReValving System. Being able to perform this procedure in a cath lab is why ReValving has extraordinary possibilities for interventionally treating the thousands of patients who have defective aortic heart valves Heart valves
Valves that regulate blood flow into and out of the heart chambers.

Mentioned in: Heart Failure
, but who are contraindicated for open-heart surgery," said Professor Serruys. "Given this patient's fragile pre-op condition, I am very impressed that her cardiac function is now significantly enhanced, as measured via post-procedure echocardiography Echocardiography Definition

Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and
."

CoreValve's system is used to replace an aortic heart valve via a percutaneous approach--on a beating heart. Excluding prep time, the second-generation CoreValve Percutaneous ReValving System used at Erasmus University Medical Center facilitated delivery and placement of a porcine porcine /por·cine/ (por´sin) pertaining to swine.

porcine

pertaining to pig. See also hog (1), swine.


porcine circovirus 1
a nonpathogenic virus.
 pericardial-tissue bioprosthesis, via a 21-French-sized catheter, during a 10-minute procedure.

"This patient's pre-operative condition was substantially impaired due to significant aortic valve stenosis Aortic Valve Stenosis Definition

When aortic valve stenosis occurs, the aortic valve, located between the aorta and left ventricle of the heart, is narrower than normal size.
 and a severely calcified Calcified
Hardened by calcium deposits.

Mentioned in: Heart Valve Repair
 aorta," said Dr. Jacques Seguin, founder, chairman and CEO of CoreValve. "Indeed, she was not considered a candidate for open-heart surgery by the surgeons at the University of Erasmus Medical Center because of her high-risk status and, in fact, this patient was out of options had it not been for CoreValve's non-surgical ReValving approach to treat her diseased aortic heart valve."

About CoreValve

Privately held CoreValve, with U.S. headquarters in Irvine, Calif., has 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 procedure--with the proprietary CoreValve Percutaneous ReValving System(TM)--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. For more information about CoreValve, visit the Company's Web site at www.corevalve.com.

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 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 industry and the economy and other factors.
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:Jan 3, 2006
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