CoreValve

March 28, 2006 12:51 ET

50 Patients Who Were Not Eligible for Open-Heart Surgery Have Now Received CoreValve's ReValving™ System to Non-Surgically Replace Their Diseased Aortic Heart Valve

IRVINE, Calif. and PARIS--(CCNMatthews - Mar 28, 2006) -

"There continue to be no device-related deaths and no device failures during implantation and at up to 14 months of follow-up. What is noteworthy is that all of these patients were considered very high risk, who would have otherwise been left untreated because they were contraindicated for the only other treatment alternative: open-heart surgery." -- Jacques Seguin, MD, PhD, Chairman, CEO and Founder, CoreValve

CoreValve (www.corevalve.com) announced today that a total of 50 patients at seven investigative sites in Germany, Holland, Belgium and Canada have now undergone percutaneous aortic valve replacement (PAVR) on a beating heart with the CoreValve Percutaneous ReValving™ System to treat either their aortic stenosis, aortic regurgitation, or failed-tissue-valve-prosthesis conditions.

"One hundred percent of the patients discharged from the hospital continue to demonstrate improved cardiac function, zero long-term complications, and enjoy substantially enhanced quality-of-life at follow-up out to 14 months," said Jacques Seguin, M.D., Ph.D., Chairman, CEO and Founder of CoreValve, a cardiac surgeon who had performed some 4,000 open-heart surgeries before becoming a medical device entrepreneur. "Considering that--if left untreated--all of these individuals would have experienced a nihilistic quality of life during their remaining time and that 25 percent of them faced the certainty of death within 12 months--we are thrilled to have been instrumental in returning these ReValving patients to a normal lifestyle where they can expect to continue enjoying time with their loved ones."

Added Rob Michiels, President and Chief Operating Officer of CoreValve: "Since August 2005, 36 patients have been treated with our second-generation, 21-French-sized system. The downsizing greatly improved the ease of the procedure and, with the exclusion of prep time, the second-generation CoreValve Percutaneous ReValving System is now routinely facilitating access, delivery and placement of our porcine pericardial-tissue bioprosthesis in less than 15 minutes. Consequently, our accomplished investigators are scheduling two procedures during the same day. Within a few months CoreValve plans to initiate the use of our third-generation system, which has been further downsized to 18-French and is expected to bring additional procedural benefits. There can be no doubt that these technical and clinical achievements have established CoreValve as the undisputed leader in percutaneous aortic valve replacement."

About CoreValve

Privately held CoreValve, with U.S. headquarters in Irvine, Calif., 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. 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 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.

Contact Information

  • Ronald Trahan Associates Inc.
    Ronald Trahan, APR, 781-762-9782, x18