The News

30 patients have now received Corevalve’s Revalving™ System to non surgically replace their diseased aortic heart valve ; none were eligible for open-heart surgery

03/02/2006

“There are no device-related deaths and no device failures during
implantation and at up to 12 months follow-up. This significant milestone
offers further dramatic evidence that CoreValve’s ReValving approach to
replacing diseased aortic valves can transform open-heart surgery into an
interventional cardiology procedure and offer hope and quality of life to
patients who would otherwise be left untreated.”
Jacques Séguin, MD, PhD, Chairman, CEO and Founder, CoreValve

IRVINE, Calif., and PARIS, Feb. 2, 2006—CoreValve announced
today that a total of 30 patients at four investigative sites worldwide have now undergone percutaneous aortic valve replacement (PAVR) on a beating heart with the CoreValve Percutaneous ReValving System™ to treat their aortic stenosis or aortic regurgitation conditions. (Since CoreValve’s second-generation, 21-French-sized prosthesis was first used last October, 15 of these 30 patients have received this advanced device during a totally uneventful procedure and returned home safely in the
following days.)

“Because of ReValving, these 30 patients were able to avoid the high risk and significant trauma of open-heart surgery. Indeed, nearly all of these patients were so fragile that open-heart surgery was contraindicated for them. In short, most of these patients had no other alternative to treating their defective aortic heart valve,” said Jacques Séguin, MD, PhD, Chairman, CEO and Founder of CoreValve. “Considering these patients’ tenuous pre-operative conditions, we are extremely pleased that their post-operative cardiac function has been significantly enhanced as a direct result of ReValving,” added Dr. Séguin. “Being able to perform ReValving in a cath lab is why our approach has extraordinary possibilities for interventionally treating the thousands of patients who have defective aortic heart valves but are contraindicated for open-heart surgery. For example, one of the most recent patients treated was a 94-year-old female who returned home just days after the successful replacement of her diseased aortic valve.” Added Jack Lips, RN, European Clinical Manager for CoreValve: “Excluding prep time,
the second-generation CoreValve Percutaneous ReValving System is routinely facilitating access, delivery and placement of our porcine pericardial-tissue bioprosthesis via a 21- French-sized catheter in less than 15 minutes. As a direct result, our experienced investigators are now routinely scheduling two procedures during the same day.”

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.

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 theforward-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.