IRVINE, Calif., Dec. 6, 2001 -- Edwards Lifesciences Corporation (NYSE: EW), a global leader in products and technologies to treat advanced cardiovascular disease, announced today the first U.S. implant of its next-generation bifurcated Lifepath AAA Endovascular Graft as part of the company's Phase II clinical study. The Lifepath AAA system is a less-invasive option for treating abdominal aortic aneurysms (AAA), a potentially life-threatening condition that involves a weakening and ballooning of the wall of the aorta, the body's main circulatory channel.
The implant occurred in a 69-year-old male patient at the Jobst Vascular Center in Toledo, Ohio. The procedure follows the U.S. Food and Drug Administration's recent approval for Edwards to resume enrollment in its clinical study of the device.
"We are pleased to have performed this procedure using Edwards' less-invasive Lifepath AAA system," said Dr. Hugh G. Beebe, director of the Jobst Vascular Center and clinical professor of surgery at the University of Michigan Medical School. "The procedure went very smoothly, with the patient recovering quickly and the product performing exactly as expected."
Edwards' Lifepath AAA system is the only balloon-expandable endovascular graft system for treating AAA. The system features design enhancements to meet the stringent requirements for AAA treatment determined through previous experience with Edwards' original Lifepath AAA product.
About the AAA Condition and Treatment
An abdominal aortic aneurysm forms in the aorta, the body's main circulatory channel, when a portion of the aortic wall becomes weakened and begins bulging outward. Often the aneurysm grows until it poses a life-threatening risk of rupturing. The Lifepath AAA system treats abdominal aortic aneurysm by using a catheter-based delivery device to place a permanent graft that reinforces the wall of the aorta in the affected area. By accessing and repairing the aneurysm from within the aorta, rather than making a major incision that exposes most of the body's internal organs, the endovascular procedure is less traumatic and invasive to patients than conventional aortic repair surgery. An estimated 120,000 people worldwide undergo the conventional AAA repair surgery each year, while approximately 250,000 additional AAA cases are believed to go undiagnosed.
Edwards Lifesciences is a leader in advanced cardiovascular disease treatments and the number-one heart valve company in the world. Headquartered in Irvine, Calif., Edwards focuses on four main cardiovascular disease states: heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure. The company's global brands, which are sold in over 80 countries, include Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty. Additional company information can be found at www.edwards.com .
Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Lifepath AAA, Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty are trademarks of Edwards Lifesciences Corporation, registered in the U.S. Patent and Trademark Office.
Contact Information :
Media, Scott Nelson, +1-949-250-5070, or Investors, David K. Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation