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Edwards Lifesciences Makes Move Into Stent Market

Edwards Lifesciences Makes Move Into Stent Market

By VITA REED

Edwards Lifesciences Corp. said last week that it plans to launch more products to treat vascular diseases as part of a bid to expand beyond its core heart-valve business.

Edwards said it plans to develop balloon-expanding and self-expanding stents, which are used to hold open arteries. As part of the move, company officials said they have acquired the rights to develop existing coronary stents for vascular disease use in an exclusive pact with Fort Lauderdale, Fla-based Orbus Medical Technologies Inc.

Separately, Edwards said it signed on Syntheon LLC of Miami to do initial design, engineering and production of the company’s stents. But Edwards officials said they plan to eventually take those operations in-house.

“We’ve been interested in peripheral vascular disease for a long time,” said Stuart Foster, Edwards’ corporate vice president of technology and discovery.

Edwards already offers some vascular disease products, including balloon catheters and the company’s Lifepath AAA Graft System, which is designed to treat aneurysms.

Peripheral vascular disease occurs when arteries that carry blood through the body become narrowed or clogged, resulting in diminished blood flow. Stents are inserted into restricted arteries via a catheter to open up the vessels and maintain blood flow.

The global stent market is estimated at around $600 million a year, with annual growth projected in excess of 10%. Rivals include the Cordis division of Johnson & Johnson, Guidant Corp. and Boston Scientific Corp.

Foster said he believes there is room for Edwards: “Peripheral vascular disease is very under-treated,” he said.

Vascular disease often occurs in the legs, Foster said. Surgery only is an option in the most severe cases.

Edwards said it expects to have a broad stent product line for global release in mid-2003. The company called its stent investment a “significant part” of its research and development spending for 2002, which is set to rise 20%

In another development, Edwards said that its Lifepath endo vascular graft was implanted in its first American patient as part of a second-phase clinical study. A 69-year-old man at the Jobst Vascular Center in Toledo, Ohio, got the implant, which is designed to treat abdominal aortic aneurysms.

Edwards has touted Lifepath as a less-invasive treatment for the condition, which encompasses weakening and ballooning of the wall of the aorta, the body’s main circulatory channel.

Lifepath and the stent expansion are key parts of Edwards’ bid to expand beyond heart valves. The company is spending about half of its research and development budget on devices other than heart valves, according to Foster. Heart valves made up nearly half of the company’s $384 million in first-half sales.

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, an analyst with William Blair & Co. in Chicago, believes Lifepath can help broaden Edwards’ base. Andrew estimates that the treatment market for abdominal aortic aneurysms could be $600 million to $800 million within the next three to five years.

But Andrew also pointed out that “Edwards is late to the party” as Guidant and Medtronic Inc. already are in the aneurysm device market. Still, “the market is $200 (million) to $300 million today. There will be room for Edwards.”

In his report, First Union’s Jay pointed out that he believed that doctors would welcome a new option for abdominal aortic aneurysm treatment “when it becomes available as the approved devices still have performance shortcomings.”

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

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

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