First Patient Treated in Clinical Trial of Edwards LifeStent NT Self-Expanding Stent for Treating Peripheral Vascular Disease

IRVINE, Calif., July 23 -- Edwards Lifesciences Corporation (NYSE: EW), a global leader in medical technologies to treat advanced cardiovascular disease, announced today the successful treatment of the first patient in its RESILIENT (Randomized Study Comparing the Edwards Self-ExpandIng LifeStent vs. Angioplasty-alone In LEsions INvolving The superficial femoral artery or proximal popliteal artery) clinical investigation using the Edwards LifeStent NT Self-Expanding Stent system to treat patients with peripheral vascular disease. The LifeStent NT Self-Expanding Stent is a percutaneously-delivered flexible mesh tube that expands when deployed to prop open a diseased vessel.

The first patient, who was suffering from peripheral vascular disease in his superficial femoral artery (SFA), was treated by one of the study's co-principal investigators, John Laird, M.D., Director of Peripheral Vascular Interventions at the Cardiovascular Research Institute at the Washington Hospital Center, Washington, D.C.

""As a part of the RESILIENT protocol, the patient was first treated with percutaneous transluminal angioplasty,"" said Dr. Laird. ""But subsequent use of the LifeStent system immediately produced much better results, allowing significantly increased blood flow.""

""The opportunity to provide a stent we believe is optimally designed for the unique clinical demands of peripheral vascular disease is an important step in Edwards Lifesciences' strategy to further build upon our interventional capabilities, and should ultimately be of great benefit to patients,"" said Stuart L. Foster, Edwards' corporate vice president, Technology & Discovery. ""The LifeStent self-expanding stent has a unique helical design that provides for a highly flexible, yet radially strong structural scaffold that is well-suited to withstand the continual bending and flexing experienced in the SFA.""

The SFA is a blood vessel in the back of the leg that extends beyond the knee as the popliteal artery. This is a common area of blockages in patients who suffer from atherosclerosis of the lower extremities, causing moderate to severe pain due to poor blood flow in the leg muscles. Patients customarily have been treated with balloon-based percutaneous transluminal angioplasty (PTA) to open their blockages, but PTA's high incidence of restenosis, or ""reblockage,"" of the artery has resulted in increasing use of endovascular stents as a longer-term and more beneficial alternative. Lower-extremity peripheral arterial disease affects approximately 3 percent of people younger than 60 years and 20 percent of people older than 70 years.

Edwards' RESILIENT study is a randomized, controlled clinical trial that differs from other SFA investigations because it is intended to demonstrate superiority, not equivalence, of the LifeStent NT Self-Expanding Stent system over PTA in treating blockages in the SFA and popliteal artery. Approximately 220 U.S. patients are expected to be enrolled in the RESILIENT trial, which will take place at up to 25 medical institutions throughout the country.

LifeStent NT Self-Expanding Stent System Introduced in U.S.

Edwards Lifesciences also announced the limited launch of the first sizes of its Edwards LifeStent NT Self-Expanding Stent system for use in treating biliary disease. The stent's proprietary, self-expanding triple helix design provides physicians with a unique and highly flexible intraluminal scaffold with sufficient radial strength to address clinical needs in a challenging area of the anatomy.

""In June, we completed the rollout of our entire balloon-expandable stent line,"" said Foster. ""The introduction of our new self-expanding stent system represents another important milestone as we also continue to strengthen Edwards' core capabilities in critical technical areas that are shared with our other interventional programs.""

Edwards obtained FDA 510(k) clearance for the system to treat biliary obstructions and is seeking European CE Mark approval for the LifeStent NT Self-Expanding Stent system to treat peripheral vascular disease. The company will continue to introduce additional stent sizes throughout the third quarter of 2004.

About Edwards Lifesciences

Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://www.Edwards.com.

Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG.

This news release includes forward-looking statements that involve risks and uncertainties, including those related to the expected clinical performance and superiority of the Edwards LifeStent NT Self-Expanding Stent system; the ability to complete the RESILIENT clinical trial; the market introduction of the LifeStent NT system; the ability to obtain desired regulatory approvals for the LifeStent NT system; and more generally, timing or results of pending or future clinical trials, actions by the U.S. Food and Drug Administration and European Union, technological advances in the medical field, product demand and market acceptance, the effect of changing economic conditions, the impact of foreign exchange, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.