Elixir snags CE mark for dissolvable stent

Elixir Medical won a CE mark for the DESolve stent.--Courtesy of Elixir Medical

While Abbott Laboratories ($ABT) leads the way in the dissolvable stent market, California's Elixir Medical is right on its heels, winning CE mark approval for the DESolve device.

The novolimus-eluting implant is designed to treat coronary artery disease by propping open vessels for about one year before harmlessly degrading, leaving patients free of a permanent metallic stent. Elixir won the CE mark on the strength of a 120-patient pivotal trial wrapped up in October, and the company is scheduled to unveil those results at next week's EuroPCR conference in Paris.

Elixir said it plans to start selling a broad range of DESolve sizes around the world later this year. The company hasn't said whether or when it will pursue FDA approval for the device, and Elixir didn't respond to a request for comment Wednesday.

Abbott won a CE mark for the similar Absorb last year and has been selling the device around the world since September, but Elixir believes DESolve's ability to maintain radial strength, self-appose to the nominal vessel wall and return patients to normalcy after one year will put it at the forefront of the dissolvable stent market.

"The goal of the interventional cardiologist is to treat and return the patient arteries to their de novo state," CEO Motasim Sirhan said in a statement. "We believe the DESolve scaffold makes this goal a reality."

As it prepares to roll out DESolve abroad, Elixir is also working to expand its U.S. share of the traditional stent market. Earlier this month, the FDA gave its blessing to a 2,051-patient trial of Elixir's DESyne drug-eluting stent, which the company will compare to Medtronic's ($MDT) Resolute with an eye on stateside approval.

- read Elixir's announcement

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