Elixir Medical has secured CE Mark certification for its DESolve Novolimus eluting bioresorbable coronary scaffold system, which is designed to degrade in one year’s time, bringing the patients’ coronary vessel back to its normal state.
Developed based on the company’s proprietary poly-L Lactide (PLLA)-based polymer, the DESolve scaffold provides strength and support to the artery while delivering the novel anti-proliferative drug, Novolimus.
CE Mark approval was given based on the results of the international pivotal DESolve Nx trial, which company had submitted as part of the application.
Elixir Medical‘s DESolve scaffold programme chairman Dr Martin Leon said the approval brings to the market a differentiated product platform with important advantages.
"Elixir’s DESolve may help to transform the interventional treatment of patients with coronary artery disease by providing optimal vessel support when needed and degrading in about a year leaving the vessel free of a permanent metallic implant," Leon said.
The trial, which was conducted on 120 patients at 15 centres in Europe, Brazil and New Zealand, represented one of the major bioresorbable scaffold clinical trials with QCA (quantitative coronary angiography) follow-up in the industry so far.
The composite of major adverse cardiac events, comprising cardiac death, target vessel myocardial infarction and clinically-indicated target vessel revascularisation, was the primary safety endpoint of the trial, and in-scaffold late lumen loss at 6 months as assessed by QCA (quantitative coronary angiography) formed the primary angiographic endpoint.
DESolve Nx study co-principal investigator Dr Stefan Verheye said the CE certification marks a major milestone that is in accordance with the results of the device performance found in the clinical setting.
"Having used the DESolve bioresorbable scaffold system in the first-in-man study and observed its outstanding performance in the clinic during the subsequent DESolve Nx pivotal trial, I am confident that Elixir’s fully bioresorbable DESolve system is poised to lead the next frontier of interventional cardiology innovation," Verheye said.
Plans are ahead to begin the commercial sales of a broad range of DESolve in various select international markets later this year.
Elixir Medical chief executive officer Motasim Sirhan said; "The goal of the interventional cardiologist is to treat and return the patient arteries to their de novo state. We believe the DESolve scaffold makes this goal a reality".