Elixir Medical’s DESolve Novolimus eluting bioresorbable coronary scaffold system won European CE Mark approval, the privately held Sunnyvale, Calif.-based company announced today.
DESolve is designed to degrade in about 1 year, returning the patients’ coronary vessel to its normal de novo state.
Elixir plans to initiate commercial sales of DESolve in a broad range of sizes in select international markets later this year, according to a press announcement.
"The CE Mark approval for DESolve brings to the market a differentiated product platform with important advantages," Dr. Martin Leon, chairman of Elixir’s DESolve scaffold program, said in a press statement. "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."
Results of the international pivotal multi-center DESolve Nx trial, which helped the device win a CE Mark, will be presented in Paris next week at the annual EuroPCR meeting, the company said.
"DESolve’s unique characteristics include its ability to maintain radial strength and vessel support for the critical period of vessel healing, the ability to self-appose to the nominal vessel wall, its excellent scaffold expansion range, and its ability to degrade in the body in about a year," Dr. Alexandre Abizaid, of the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, and co-Principal Investigator of the DESolve Nx trial said in a press statement.
The DESolve Nx trial, designed to enroll 120 patients at 15 centers in Europe, Brazil and New Zealand, is one of the largest bioresorbable scaffold clinical trials with quantitative coronary angiography (QCA) follow up to date, Elixir notes.
DESolve Nx’s primary safety endpoint is the composite of major adverse cardiac events (MACE) comprised of cardiac death, target vessel myocardial infarction (MI) and clinically-indicated target vessel revascularization (TLR), the company said.
The trial’s primary angiographic endpoint is in-scaffold late lumen loss at 6 months as assessed by QCA. In a sub-set of patients, additional QCA assessment will be conducted at 24 months, according to Elixir.
Scaffold and vessel assessment using IVUS (Intravascular Ultrasound), OCT (Optical Coherent Tomography) will be conducted at baseline, 6 and 24 months, and MSCT (Multi Slice Computed Tomography) will be conducted at 12 months, providing long-term assessment of the scaffold, the company added.
"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," Dr. Stefan Verheye, of ZNA Middleheim Hospital in Antwerp, Belgium, and co-Principal Investigator of the DESolve Nx study said in a press statement.