California stent-maker Elixir Medical won approval from European regulators for its next-generation DESolve 100 fully resorbable coronary scaffold.
The new model gets its name from its "dramatically thinner" 100 micron strut profile, which the company hopes will help doctors extend treatment to a broader patient population. Like the original DESolve stent, the new 100 model elutes the drug Novolimus, self-apposes to the vessel and degrades completely within 1 year.
The original DESolve won CE Mark approval in May 2013.
"Elixir’s DESolve scaffold is already transforming the treatment of patients with coronary artery disease by providing the optimal vessel support while degrading in about a year, leaving the vessel free of a permanent metallic implant," said Belgium-based Dr. Stefan Verheye, who treated the first patient with DESolve 100. "The CE Mark approval for the breakthrough DESolve 100 scaffold builds on the clinically-proven success of DESolve."
The approval was granted based on results from the 126-patient DESolve Nx study involving 13 clinics in Europe, Brazil and New Zealand, according to a press release. The same study helped the company win European approval for the original DESolve stent.
"Elixir’s DESolve scaffold achieved the goal of the interventional cardiologist to treat and return the patient’s arteries to their de novo state in one year," CEO Motasim Sirhan said in prepared remarks.
With CE Mark in hand, Elixir plans to conduct a postmarket study of 100 patients in Brazil and Europe, the company said.
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