Healthcare Industry News: Percutaneous Aortic Valve Replacement
News Release - November 30, 2006
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 procedures--wholly percutaneous--and therefore a remarkable future alternative to open-chest surgery for replacing a diseased aortic heart valve."
Jacques Seguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve
IRVINE, Calif.--(HSMN NewsFeed)--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 pericardial tissue bioprostheses over the severely diseased aortic heart valves of four consecutive high-risk patients: two at the HELIOS Heart Center (HHC), Siegburg, Germany, by Prof. Eberhard Grube, and two at the University of Leipzig (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 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 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. 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.
Founded in 2001, privately held CoreValve--which is headquartered in Irvine, California--has developed a proprietary delivery system for percutaneous heart valve replacement, 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(TM) System--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 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.)
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