Medinol, a developer of Interventional Cardiology devices, announced today the completion of enrollment in its BIONICS trial, a global, prospective, randomized, multicenter, clinical trial designed to evaluate the safety and effectiveness of a new Coronary Stent System, the first ever elastomeric Drug Eluting Stent or eDESTM. The BIONICS trial enrolled 1,918 patients in the U.S., EU, Canada and Israel and the results will be submitted to the FDA for the U.S. approval of the eDES for the treatment of patients with narrowing or blockage of their coronary arteries.
There are several aspects of this stent that differentiate it from other products currently available. The eDES is coated with an elastomer that maintains a smooth and uniform stent surface designed to prevent the cracking or peeling that may occur with brittle polymers used in other DES during the stent crimping and deployment processes. The stent is comprised of cobalt chromium and manufactured and coated in flat panels utilizing Medinol's patented QualitySurfaceTM Technology and contains a "limus" family drug, intended to prevent restenosis. The eDES design is based on the clinically proven NIRxcell™ stent architecture intended to enhance conformability, scaffolding and radial strength. The delivery system is unique as well, featuring a distinctive spring tip that is simultaneously more pushable and flexible than the plastic tips used on other delivery systems.
"The design of eDES enhances stent deliverability and conformability for the treatment of complex coronary disease. The system is unique from other products currently being offered, and will be a great addition to our current treatment options." said David Kandzari, M.D., F.A.C.C., Director of Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA and principal investigator for the BIONICS trial. Additionally, Dr Kandzari was impressed with several aspects of the study, that proved to be ground-breaking, and very different from past DES clinical trials, "One of the distinctive aspects of the study is how inclusive the enrollment criteria is, allowing for almost all patient populations to be included in the study, and making it very relevant to the populations we see in our practices today. We look forward to getting the results after follow up."
The BIONICS clinical trial is a 1:1 randomized study comparing the eDES System to Medtronic's Resolute Integrity™ Stent System. The primary endpoint of the study is target lesion failure (TLF) as determined at 12 months. The eDES System is an investigational device and is not available for commercial sale.
"Medinol has been dedicated to the development of products to improve the quality of life for patients for years. We have spent a lot of time studying coronary vasculature and have focused our efforts on product designs that 'respect the vessels' through both conformability and scaffolding," said Dr. Judith Richter, CEO of Medinol. "We believe that our innovative eDES will offer a significant advancement in patient treatment options based on stent and elastomer coating design improvements and overall deliverability."