Elixir bolsters recent CE mark with successful pivotal trial

Elixir Medical's DESolve proved effective in a pivotal trial.--Courtesy of Elixir Medical

Less than a week after securing a CE mark for its DESolve drug-eluting stent, Elixir Medical reported successful results in a pivotal trial of the same device, which should reach the market by the end of this year.

In the 6-month trial of 126 patients that ended last year in October, the completely dissolving stent, which delivers the drug novolimus to treat coronary artery disease, effectively propped open the blood vessel with a low 3.25% rate of major adverse cardiac events. The company announced the results at the EuroPCR conference in Paris.

This brings Elixir closer to rival stentmaker Abbott ($ABT), whose similar bioresorbable drug-eluting Absorb stent has been on the market outside the U.S. since September. But Elixir has its hand in a few different stent markets as the only company with three CE-marked drug-eluting models: the biodegradable DESyne, the durable polymer DESyne and this one, the DESolve.

"DESolve is the first scaffold that degrades in about one year while achieving excellent clinical safety and efficacy outcomes by having low acute recoil, the required radial strength with no chronic recoil, and the optimal drug dose to suppress neointimal proliferation," trial co-principal investigator Alexandre Abizaid said in a statement. Said trial co-principal investigator Stefan Verheye: "These impressive results have the potential to create a paradigm shift in the treatment of patients with cardiovascular disease."

- here's the release

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