Launched at European Society for Vascular Surgery Meeting
LUCERNE, Switzerland and IRVINE, Calif., Sept. 27, 2001 -- Edwards Lifesciences Corporation (NYSE: EW) announced today at the 15th Annual Meeting of the European Society for Vascular Surgery in Lucerne that it has received ""CE-Mark"" approval to market its next-generation Lifepath AAA Endovascular Graft System within the European Community. 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. Edwards will begin commercial rollout of the enhanced Lifepath AAA system in Europe immediately.
"We are pleased to have met the necessary European regulatory milestones for our next-generation Lifepath AAA system and to be offering this potentially life-saving therapy to patients even sooner than we had expected," said Stuart L. Foster, corporate vice president, Technology & Discovery, noting that Edwards had initially hoped to resume European sales of the product by year end. "As the only balloon-expandable option for treating AAA, the Lifepath AAA system builds on our strong global franchise focused on peripheral vascular disease, and underscores our commitment to developing innovative products that address unmet clinical needs."
The next-generation Lifepath AAA system features design enhancements to meet the stringent requirements for AAA treatment determined through experiences with previously available therapies, including Edwards' original Lifepath AAA product. These next-generation enhancements include a stronger ""wireform"" support for the graft and improvements in the device's delivery system. The wireform is an alloy that runs through the tubular graft's fabric-covered walls.
In April 2000, Edwards took the precaution of voluntarily suspending sales of the original Lifepath AAA product outside of the United States, as well as U.S. and European clinical trials, following the discovery of patient cases in which the product's wireform had fractured. The original Lifepath AAA graft continues to perform well in those patients who have been treated with the device and the vast majority of these patients have experienced shrinkage of their aneurysms.
Following the voluntary suspension, Edwards conducted a thorough review, redesign and retesting process before seeking the CE Mark for its next-generation Lifepath AAA system.
"I am very pleased to be able to offer Edwards' next-generation Lifepath AAA system to my patients who suffer from the serious AAA condition," said Professor Jens-Rainer Allenberg, chief of vascular surgery, Ruprecht-Karls University, Heidelberg, Germany. "The product's balloon expandability, combined with its standard-thickness graft material, make the Lifepath AAA system an effective treatment choice."
About the AAA Condition and Treatment
An abdominal aortic aneurysm can form 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., with European regional headquarters in St. Prex, Switzerland, 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.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to successful European commercial sales of the next-generation Lifepath AAA system, targeted financial and operating objectives, the company's transformation into a faster-growing organization, and more generally, the ability to consummate targeted technology investments and acquisitions, 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.
Contact Information :
Media, Scott Nelson, +1-949-250-5070, or Investors, David K. Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation