Elixir Medical Corporation (Sunnyvale, CA) won the European CE Mark to begin marketing its DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System. The device dissolves within the vessel in about a year, leaving a properly shaped lumen that no longer requires support.
Novolimus, the drug deposited on the DESolve is, according to the company, a “novel mTOR inhibitor macrocyclic lactone with anti-proliferative and anti-inflammatory properties developed by Elixir for site specific therapies.”
From the press release:
Results of the international pivotal DESolve Nx trial, designed to enroll 120 patients at 15 centers in Europe, Brazil and New Zealand were submitted as part of the CE Mark application, and will be presented in Paris in the Main Arena of the Palais Des Congres de Paris at the “From Late Breaking Trial to Clinical Practice” session of EuroPCR 2013 on Tuesday, May 21. The DESolve Nx trial represents one of the largest bioresorbable scaffold clinical trials with QCA (quantitative coronary angiography) follow up in the industry to date.
The primary safety endpoint of the DESolve Nx trial 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 primary angiographic endpoint of the trial is in-scaffold late lumen loss at 6 months as assessed by QCA (quantitative coronary angiography). In a sub-set of patients, additional QCA assessment will be conducted at 24 months; scaffold and vessel assessment using IVUS (Intravascular Ultrasound), OCT (Optical Coherent Tomography) will be also conducted at baseline, 6 and 24 months; MSCT (Multi Slice Computed Tomography) will also be conducted at 12 months, providing long-term assessment of the scaffold.
Product page: DESolve Scaffold System…