Elixir Medical Releases Positive 12-Month Results for DESolve

Elixir Medical Corp. (Sunnyvale, CA) released positive one-year clinical results for its DESolve Novolimus eluting coronary scaffold system. Results were presented at the Transcatheter Cardiovascular Therapies Conference in San Francisco, CA."The 12-month results of the DESolve scaffold demonstrated sustained clinical outcomes at one year, further validating the scaffold as an excellent treatment option for coronary artery disease," noted one researcher.In total, the DESolve clinical trial comprises 126 patients at 13 separate centers in New Zealand, Brazil, and Europe. While all patients underwent a quantitative coronary angiography, a subset of 46 patients also underwent optical coherence tomography and intravascular ultrasound imaging at baseline of the study and at the half-year mark. Results show that the rate of major adverse cardiac events in trial patients was 5.69%.As of now, bioresorbable scaffolds have been a challenge for the medical device industry. In part, these devices require a level of structural strength that has only been found in metallic stents. However, the DESolve device is able to overcome this issue and is able to achieve patient vascular restoration within half a year.The scaffold is developed from a specialized poly-L Lactide polymer, providing durability and strength. In addition, this polymer is designed to elute Novolimus, an antiproliferative drug. The main benefits of the scaffold include its ability to have a wide expansion margin, its ability to maintain radial strength, its ability to self-appose up to a patient's nominal vessel diameter and its ability to show lumen area increase at the six-month post-vascularization mark.