The News

CoreValve announces 18-French-sized percutaneous aortic valve replacement (PAVR) breakthrough utilizing its patented ReValving™ system to non-surgically deliver a new porcine pericardium heart valve over a severely diseased aortic valve

11/05/2006

“This first-ever, successful 18-French PAVR procedure on a ‘high risk’ patient—91 years old and too fragile for open-heart surgery—bears conclusive evidence that our ReValving approach to percutaneous aortic valve replacement is well on its way toward becoming a successful future alternative to open-heart surgery.”
Jacques Séguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve

IRVINE, Calif., and PARIS, May 11, 2006—CoreValve announced today that it has successfully initiated the feasibility phase of a ‘Generation-3’ clinical trial using its patented, 18-French ReValving System. For the first time, the Company’s third-generation system, consisting of a breakthrough 18-French-sized delivery catheter, was used to percutaneously implant its proprietary porcine pericardial-tissue bioprosthesis over the severely calcified aortic heart valve of a 91-year-old female patient, who was discharged from the hospital’s ICU on the morning after her ReValving procedure, which was performed in the cardiac catheterization (“cath”) laboratory at The Heart Center, Siegburg, Germany. The ‘Generation-3’ clinical trial, which has commenced ahead of schedule, is expected to enroll up to 100 patients at 12 sites in Europe and Canada.
 
To date, every one of the 44 ReValving patients who have been discharged from the hospital continues to demonstrate improved cardiac function, zero long-term complications, and dramatically enhanced quality-of-life at follow-up out to 17 months (mean: 9.5 months).  It should be noted that, left untreated, up to 25 percent of these high-risk and inoperable patients would have faced certain death within 12 months.
 
“Being able to non-surgically replace an aortic heart valve under fluoroscopic guidance in the cath lab setting is why our ReValving System approach has such extraordinary possibilities for interventionally treating the thousands of patients who have defective aortic heart valves but who are contraindicated for open-heart surgery,” said Jacques Séguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve. “The first generation of percutaneous aortic valve replacement catheters was 25-French, which is a very sizeable catheter by interventional standards. Our third-generation device has now been reduced in size to 18-French—a rather extraordinary technical achievement in the less-than-two years since our ‘first-in-man’ procedure—with significant procedural benefits for the interventional cardiologist and his patient.”
 
Added Rob Michiels, President and Chief Operating Officer: “This rapid technological progress is the result of a strategy that focused on a new design for a bioprosthesis specifically for percutaneous application, and it positions CoreValve as the undisputed leader in percutaneous aortic valve replacement. Indeed, we believe we are on schedule to secure a CE Mark and first-to-market position for our ReValving System in Europe next year.”

About CoreValve
Founded in 2001, privately held CoreValve—which is headquartered in Paris and has R&D and manufacturing facilities 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 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.  

 
Forward-Looking Statements
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™ System will not be available in the USA for clinical trials or for commercialization until further notice.)