The News

Corevalve sucessfully inititates first North American clinical trial, using its novel revalving™ system at Montreal Heart Institute to non-surgically replace diseaded aortic heart valve of 64-year-old female patient not eligiblefor open-heart surgery

13/12/2005

“The life of this patient was transformed in a matter of a few minutes, without surgery, from being significantly impaired to normal-functioning as a direct result of ReValving. The procedure was performed in a hospital cath lab, not a cardiac OR, and avoided massive open-chest open-heart surgical trauma. Percutaneous aortic valve replacement (PAVR) via CoreValve’s ReValving approach is the area of legitimate excitement for the future of interventional cardiology, now that stenting and angioplasty are commonplace procedures.” Jacques Séguin, MD, PhD, Chairman, CEO and Founder, CoreValve

IRVINE, Calif., and PARIS, Dec. 13, 2005—CoreValve  announced today that follow-up testing conducted several days after the first percutaneous ReValving™ procedure performed in North America to replace a patient’s defective aortic heart valve showed perfect functioning and anchoring of the new biological heart valve. Because of ReValving, the 64-year-old high-surgical-risk female patient was able to avoid open-heart surgery. The successful procedure was performed by Dr. Raoul Bonan, an interventional cardiologist at the Montreal Heart Institute, Quebec, Canada. He was assisted by Montreal Heart Institute colleagues Dr. Raymond Cartier, cardiac surgeon, and Dr. Andre Denault, cardiac anesthesiologist. In addition, Dr. Bonan also was assisted by Dr. Jean-Claude Laborde, an interventional cardiologist at Clinique Pasteur, Toulouse, France, who has had extensive clinical experience with the CoreValve Percutaneous ReValving System™.

CoreValve has developed a system for replacing an aortic heart valve via a percutaneous approach—on a beating heart. Excluding prep time, the second-generation CoreValve Percutaneous ReValving System holds, delivers and places a porcine pericardial-tissue bioprosthesis, via a small, 21-French-sized catheter, during a 15-minutes-or-less procedure performed by an interventional cardiologist in a cath lab setting, just like angioplasty and stenting.

“It is important to point out that this patient’s pre-op condition was substantially impaired by a very severe idiopathic pulmonary fibrosis and a significant stenotic aortic heart valve,” said Dr. Jacques Séguin, founder, chairman and CEO of CoreValve. “In fact, she was not considered a candidate for open-heart surgery by the surgeons at the Montreal Heart Institute because of her high-risk status (i.e., severe idiopathic pulmonary fibrosis) and, in short, this patient was out of options had it not been for CoreValve’s non-surgical ReValving approach to treat her defective aortic heart valve.”

“We are very pleased that the ease of the CoreValve ReValving procedure may offer a valve-replacement option to non-surgical patients and thereby greatly improve their quality of life,” said Dr. Raoul Bonan. “In this patient’s particular situation, for example, her cardiac function is now greatly improved as evidenced by post-procedure echocardiography. Considering that, pre-ReValving, she was ‘NYHA functional classification IV,’ this rapid turnaround of cardiovascular function is dramatic. The fact that we could perform this procedure in a cath lab is further evidence that ReValving has tremendous potential to non-surgically treat the large numbers of patients who have diseased aortic heart valves but who are not good candidates for surgery.”
“CoreValve has developed a user-friendly system for ease-of-adoption by interventional cardiologists and is now the undisputed PAVR technology leader,” added Dr. Séguin.
“Those in the know understand that CoreValve’s ReValving approach is, far and away, the clinically proven platform of choice for PAVR.”

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-selfexpanding-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.

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.