Interventional cardiology has another innovation: the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System designed to return the patients' coronary arteries ultimately to their original state.
Elixir already has two other CE Mark approved drug-eluting systems including the DESyne BD Novolimus Eluting Coronary Stent System (with biodegradable polymer) and the DESyne Novolimus Eluting Coronary Stent System (with durable polymer).
DESolve has been developed from a proprietary and proven poly-L Lactide (PLLA)-based polymer, to provide optimal strength and support to the artery while delivering the novel anti-proliferative drug, Novolimus.
The DESolve scaffold comes with unique features. For instance, it is able to self-appose to the nominal vessel wall. It is also able to maintain radial strength and vessel support as long as it takes during the critical phase of vessel healing during the scaffold's life of about a year.
The device also has a wide margin of expansion, and degrades in the body in about a year.
"The CE Mark approval for DESolve brings to the market a differentiated product platform with important advantages," Martin Leon, MD, New York - Presbyterian Hospital / Columbia University Medical Center and Chairman of Elixir Medical's DESolve Scaffold Program, said in a news release. "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."
"The CE Mark approval of Elixir's DESolve represents a major achievement in interventional cardiology as it brings together important performance characteristics that physicians are seeking for the better treatment of their patients," said Alexandre Abizaid, Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, and co-Principal Investigator of the DESolve Nx trial.
The DESolve Nx trial is one of the largest bioresorbable scaffold clinical trials with QCA (quantitative coronary angiography), according to the company statement. Results of the international pivotal DESolve Nx trial are scheduled to be presented at the late-breaking clinical trials session of EuroPCR 2013 in Paris on May 21, 2013. The trial results involving 120 patients at 15 centers in Europe, Brazil and New Zealand were submitted as part of the CE Mark application. The trial basically looks into 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 goal of the trial is "in-scaffold late lumen loss at 6 months". Additional assessments will be conducted in a specific group of the enrolled patients at 24 months aside from the scaffold and vessel assessment using IVUS (Intravascular Ultrasound), OCT (Optical Coherent Tomography) at the beginning, 6 and 24 months. The trial will also investigate the scaffold over a extended period of time.
"The CE Mark for DESolve is a major milestone that confirms the impressive results of the device performance observed in the clinical setting," said Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, and co-Principal Investigator of the DESolve Nx study. "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," according to the press release.
