CoreValve Establishes U.S. Operations, Hires Veteran Medical Device Management and Development Team.

PARIS -- "We now have a significant presence in two strategic locations: Irvine, California, where world-class technology expertise is available, and in Europe, where the first large clinical trial will be initiated."

--Jacques Seguin, MD, PhD Chairman, CEO and Founder CoreValve, S.A.

CoreValve S.A. (www.corevalve.com), a privately held medical technology company, announced today that it has established U.S. operations in Irvine, Calif., and has hired a well-known management and product development team to immediately commence operations, including: Rob Michiels, president of CoreValve's U.S. operations and chief marketing officer for CoreValve; Stanley Komatsu, Ph.D., vice president of valve operations; Than Nguyen, valve development team leader; and, Edward J. Pannek, Jr., vice president of catheter operations.

The 8,500-square-foot Irvine operation is a state-of-the-art research, development and manufacturing facility--with microbiology, biochemical, tissue-handling fixation, and tissue-valve production capabilities. CoreValve is now able to focus its proprietary development and manufacturing programs--i.e., its loading and delivery catheter systems, its ReValving(TM) frame, as well as its tissue heart valve and valve-to-frame assembly--within this new specialized facility. The Irvine manufacturing operation includes two GMP-certified 'clean rooms' for separate tissue-valve and catheter production, in addition to all necessary support functions. CoreValve's sales-and-marketing activities will be directed from Irvine and will be responsible for managing a network of partner/distributors for the early sales of first-generation ReValving(TM) products expected to be available in 2005.

"Establishing U.S. operations and bringing on board exceptional talent--the very best executives working in tissue-valve and catheter development today--is a major milestone for CoreValve," said Dr. Jacques Seguin, founder, chairman and CEO. "It is also important to note that our new U.S. facility is fully equipped for tissue-valve development and catheter work, and has been previously certified by regulatory authorities.

"From our earliest development efforts, we have recognized the strategic importance of controlling our valve technology. However, to accelerate system development, we chose to proceed to the initial phase I feasibility cases with an OEM valve," explained Dr. Seguin. "By carefully adapting a commercial valve to our proprietary frame, CoreValve has been able to achieve proof-of-concept for its ReValving approach in humans in a much shorter time."

"However, now that proof-of-concept has been established, CoreValve has integrated all design and manufacturing steps of the ReValving prosthesis, including the tissue valve component. We have attracted a team of the world's most experienced and most capable valve engineers, giving them the responsibility to design, develop and produce a fully proprietary CoreValve tissue valve," Dr. Seguin said. "Furthermore, vertical integration enables CoreValve to ensure total control over quality assurance and regulatory affairs.

"Most importantly, our recently announced early-stage clinical successes strongly suggest that the CoreValve ReValving approach has widespread potential to non-surgically treat the entire patient population in need of aortic valve replacement--all patients undergoing traditional surgery, all patients contraindicated for surgery, and all patients currently postponing surgery. This positioning certainly differentiates CoreValve from its current competitors, who are primarily focused on compassionate-use and high-risk surgical cases only," concluded Dr. Seguin, "which is why we believe that ReValving embodies an entirely new frontier for heart valve replacement."

U.S. Operations, Team Bios

Rob Michiels, President, U.S. Operations and Chief Marketing Officer for CoreValve From 1978 to 1989, Mr. Michiels held positions of increasing responsibility at Edwards-Baxter Healthcare--now Edwards Lifesciences (NYSE: EW)--most recently as vice president of global sales and marketing for heart valve therapies. From 1990 to 1991, he was vice president of sales, marketing and business development for Menlo Care Inc., an early-stage vascular access company. From 1992 to 1998, he served as president and chief operating officer of InterVentional Technologies Inc., an interventional cardiology start-up. During 1998 and 1999, he served as chief executive officer of VenPro, a development-stage venture company in cardiovascular and less-invasive surgery implants. He is a founding partner of CONSILIUM, a medical device market research company that is also active in the identification and funding of start-up technologies. Mr. Michiels holds a bachelor's degree in economics from Antwerp University in Belgium and an MBA from Indiana University.

Stanley Komatsu, Ph.D., Vice President, Valve Operations Dr. Komatsu is a world authority on valve development and manufacturing. This research and operations-management professional joined Edwards Lifesciences in 1975 as a biochemistry research manager and held the position of director of manufacturing of the cardiovascular surgery division from 1983 to 1992. During his tenure at Edwards, Dr Komatsu was instrumental in the development of manufacturing methods that improved quality, and reduced the cycle time and cost of porcine and pericardial tissue valves. More recently he worked as director of operations at Venpro and 3F Therapeutics, both start-up companies, developing new cardiac implant technologies. He holds a bachelor's degree in chemistry from the University of Hawaii and a doctorate in biochemistry from the University of California, Davis.

Than Nguyen,, Valve Development Team Leader Mr. Nguyen has more than 20 years of experience in mechanical and biomechanical product design and development. Since 1997, his consultancy has designed and developed cardiovascular medical implants from initial concept through final manufacturing, using bioprosthetic materials, plastics, Nitinol, titanium and cobalt chrome alloys. During this time, Mr. Nguyen also has designed and developed catheter-based systems for minimally invasive delivery of medical implants to treat cardiovascular disease. From 1981 to 1997, he was principal R&D engineer for Baxter Healthcare Corp. Mr. Nguyen holds a bachelor's degree in mechanical engineering from the Univ. of South Carolina and is a graduate of the U.S. Naval Academy.

Edward J. Pannek, Jr., Vice President, Catheter Operations Mr. Pannek is an R&D and operations manager with an extensive hands-on track record in the development of catheter-based technologies. Skilled not only in the development, but also in the engineering and manufacturing, of medical devices, his career spans U.S. and European assignments with IMED, Process Control Technologies, Kendall Corp, and Interventional Technologies Inc. (Boston Scientific Corp). From 1993 to 2001, Mr. Pannek was responsible for the development, planning, implementation and maintenance of manufacturing methods, processes, and operations, facility design and plant construction for IVT Europe Ltd. His most recent position was as vice president of process development with Boston Scientific. Mr. Pannek's educational background includes certification as journeyman tool, die and mold maker.

About CoreValve

Privately held CoreValve, S.A., headquartered in Paris, France, has developed a proprietary delivery system for percutaneous heart valve replacement, based on a novel catheter-and-self-expanding-stent approach on a beating heart, thus avoiding open-heart surgery. The CoreValve procedure--with the proprietary CoreValve Percutaneous ReValving System(TM)--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.