Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced enrollment initiation for a 120-patient, international pivotal clinical study to evaluate the safety and efficacy of the DESolve™ Novolimus Eluting Bioresorbable Coronary Scaffold System designed to resorb in the body within 1 to 2 years after implantation and return the patients' coronary vessel to de novo state. A real-time presentation of this revolutionary technology was successfully demonstrated at the 23rd Annual Transcatheter Therapeutics (TCT) Conference held in San Francisco.
“We are excited about providing physicians with multiple sizes of the DESolve System to address broad patient population needs.”
The DESolve Nx Trial is a multi-center, prospective study and will enroll 120 patients at up to 15 centers in Germany, Belgium, Poland, Brazil and New Zealand to evaluate the safety and efficacy of Elixir's DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System. The DESolve system comprises of a proprietary poly-L Lactide (PLLA)-based polymer scaffold that provides support to the coronary artery while delivering the anti-proliferative drug Novolimus, and is designed to fully bioresorb in the body within 12 to 24 months. The DESolve Nx international trial follows the completion of Elixir's DESolve First-In-Man Study enrollment, initial clinical findings of which were presented at TCT earlier this week.
"Bioresorbable drug eluting scaffold technology that leaves no permanent metallic implant behind has clearly emerged as the next frontier of interventional cardiology," said Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, and Principal Investigator of the DESolve Nx Study, who also performed the live case at TCT. "Having used the DESolve Scaffold System in my clinic and observed its impressive performance in the first-in-man trial, I am excited about the positive impact this extraordinary technology may hold for our patients. I am also pleased with the multiple sizes of scaffolds that Elixir has available for this pivotal trial in order to readily support different coronary vessel requirements."
The primary safety endpoint of the DESolve Nx trial will be 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 will be in-stent late lumen loss at 6 months for all patients as assessed by QCA (quantitative coronary angiography). In a sub-set of patients, in-stent late lumen loss will be evaluated by QCA at 6 and 24 months; stent and vessel assessment using IVUS (Intravascular Ultrasound), OCT (Optical Coherent Tomography) will be conducted at baseline, 6 and 24 months; and multi-slice computed tomography (MSCT) at 12 months thus providing long-term assessment of the scaffold and surrounding vessel.
"Fully bioresorbable scaffolds for the treatment of diseased heart vessels have been the sought after destination in interventional cardiology therapies, and Elixir Medical is committed to becoming a leader in the development of such innovative products," said Motasim Sirhan, Chief Executive Officer of Elixir Medical. "We are excited about providing physicians with multiple sizes of the DESolve System to address broad patient population needs."
Source Elixir Medical Corporation