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CoreValve establishes ReValving(TM) as repeatable, pure cath-lab procedure for PAVR on a beating heart: no cardiac assistance (neither mechanical assistance, drug-induced hypotension or rapid pacing) and no surgical vessel cut-down.


"Within the framework of our ongoing Phase III international clinical trial, we have now implanted our valve into the naturally beating heart of several patients without need for extraneous support assistance and without any surgical vessel cut-down, and we can clearly say that ReValving will be like all other cath-lab proceduresCowholly percutaneousCoand therefore a remarkable future alternative to open-chest surgery for replacing a diseased 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."

Jacques Seguin, M.D., Ph.D., 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 of CoreValve

IRVINE, Calif. -- CoreValve (www.corevalve.com) announced today that its patented ReValving System, consisting of a breakthrough 18-French-sized delivery catheter, was used to percutaneously implant its proprietary 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 pericardial /peri·car·di·al/ (-kahr´de-al)
1. pertaining to the pericardium.

2. surrounding the heart.


pericardial

pertaining to the pericardium.
 tissue bioprostheses over the severely diseased aortic heart valves Heart valves
Valves that regulate blood flow into and out of the heart chambers.

Mentioned in: Heart Failure
 of four consecutive high-risk patients: two at the HELIOS Heart Center (HHC HHC Home Health Care
HHC Headquarters Company
HHC Health and Hospitals Corporation (New York, NY)
HHC Hand-Held Computer
HHC Hiphopcanada Inc.
), Siegburg, Germany, by Prof. Eberhard Grube, and two at the University of Leipzig The University of Leipzig (German Universität Leipzig), located in Leipzig in the Free State of Saxony (former Kingdom of Saxony), Germany, is one of the oldest universities in Europe.  (Germany) Heart Center, by Prof. Gerhard Schuler.

These successful ReValving procedures are particularly noteworthy because each was performed (1) without the necessity of a surgical cut-down for catheter access (thus requiring no surgeon to be present); (2) 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; (3) without any other cardiac assistance or even rapid pacing. These cases each took routine interventional times to complete, and all patients were released from the ICU ICU intensive care unit.

ICU
abbr.
intensive care unit



ICU

see intensive care unit.

ICU 
 within hours of the completion of their ReValving procedure and discharged from the hospital within days.

"ReValving is maturing into a standard and very straightforward cath-lab procedure," said Prof. Grube. "Because we are now able to repeat the ReValving procedure in a naturally beating heart without the associated complexity and risk of extraneous manipulations such as cardiac assistance or rapid pacing, and in addition through a true percutaneous access without the necessity of a surgical cut-down to the femoral artery, I am encouraged that, in the not-too-distant future, interventional cardiologists will be able to treat many patients in the cath lab, rather than having to refer them for open-chest surgery."

"These latest clinical results clearly establish ReValving not only as a pure cath-lab procedure, but also as the unequivocal leader in 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. . Because of the small (18-French) size of our delivery catheter, we can access the femoral artery without the need for surgical repair, which means that a surgeon is no longer required to assist. In addition, the simplicity of our self-expanding system and its minimal obstruction of blood flow allow us to avoid rapid pacing of the heart during implantation. Our team is totally focused on completing the clinical work that will lead to a CE Mark and first-to-market position for our ReValving technology in Europe during 2007," said Jacques Seguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve.

About CoreValve

Founded in 2001, privately held CoreValveCowhich is headquartered in Irvine, CaliforniaCohas 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 procedureCowith the proprietary CoreValve Percutaneous ReValving[TM] SystemCocan 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 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.

(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 30, 2006
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