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HEALTHCARE: Edwards Lifesciences Sees European Implants of Endovascular Graft

Edwards Lifesciences Sees European Implants of Endovascular

By VITA REED

Irvine-based Edwards Lifesciences Corp. said four European patients received its Lifepath AAA Endovascular Graft on the first day of its availability there last week.

Patients in Belgium and Germany got the implants, which are designed to treat abdominal aortic aneurysms.

Edwards bills the Lifepath AAA system as a less-invasive treatment for the condition, which involves a weakening and ballooning of the wall of the aorta, the body’s main circulatory channel.

Lifepath is a key product in Edwards’ bid to expand beyond its core heart-valve market. Edwards is spending about half of its research and development budget on devices other than heart valves, according to Stu Foster, the company’s vice president of technology and discovery.

European regulators awarded a CE-mark to Lifepath in September. In the U.S., Lifepath has resumed second-phase clinical trials after Edwards voluntarily stopped a previous test last year because of wire form fractures in some of the devices.

Lifepath “really addresses peripheral vascular disease, which is an area we’ve targeted for investment, in addition to heart valve therapy,” Foster said.

In a research report, Andrew Jay of First Union Securities wrote that Lifepath and other new Edwards products “give us greater confidence in our 2001 and 2002 EPS estimates.”

Ben Andrew of William Blair & Co. points to Lifepath as something that could broaden Edwards’ base.

He estimated the market for treating abdominal aortic aneurysms could be $600 million to $800 million within the next three to five years.

But, he said, “Edwards is late to the party” as rivals Medtronic Inc. and Guidant Corp. already are in the aneurysms device market.

Still, “the market is $200 to $300 million today,” Andrew said. “There will be room for Edwards.”

“While they will not be one of the first players to market, we believe that physicians will welcome a new option when it becomes available as the approved devices still have performance shortcomings,” said Jay of First Union Securities.

Lifepath’s thicker material and balloon-expandable delivery system, according to Jay, could provide better results for aneurysm patients in the long term.

“At $8,500 (to) $9,000 per device, the (Lifepath) opportunity exceeds $1.5 billion,” Jay said in his report, noting that the market is barely penetrated. n

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