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Medinol announces completion of enrollment in its EluNIR HIGH BLEEDING RISK (HBR) trial. A prospective, multi-center, single-arm, open-label post marketing clinical trial, to assess the safety and efficacy of the EluNIR Drug Eluting Stent (DES) in combination with shortened DAPT duration, in patients undergoing PCI who are considered to be at high bleeding risk.
The EluNIR-HBR trial enrolled 316 patients across 18 sites in the UK and Israel, to collect and analyze data on the safety and efficacy of shortened DAPT duration (30 days in stable patients and up to 90 days in ACS patients) undergoing PCI using the EluNIR DES.
The Primary endpoint of the EluNIR-HBR study is a composite of cardiac death, myocardial infarction or stent thrombosis at 1 year (ARC definite and probable).
“The EluNIR-HBR study will allow us to determine the optimal duration of DAPT following PCI among this group of complex patients”, said Medinol’s Chief Scientific Officer, Yoram Richter, PhD., “and to further confirm the benefits of the exceptional healing characteristics that EluNIR can offer to HBR patients”.
EluNIR is Medinol’s sixth generation coronary stent featuring the unique WiZeCell™ stent design which minimizes strut dimensions leading to the lowest possible metal footprint. Combined with a spatially optimized drug delivery, the EluNIR stent is designed to promote rapid vascular healing. In the pivotal more-comers BIONICS study which recruited 1919 patients, this resulted in an exceptionally low late stent thrombosis rate of 0% at one year.
was founded in 1992 by Drs. Judith and Kobi Richter. It’s a privately held company with offices in the U.S. and Israel and employs more than 300 people. Medinol has an extensive patent portfolio, including a long, established history in the coronary stent market for over 25 years. The unique design of its products, along with its rigorous standards of manufacturing and safety, makes Medinol a leading developer in this space. All Medinol’s cardiovascular intervention solutions are manufactured in-house using its proprietary QualitySurface™ manufacturing technology. This unique manufacturing method enables Medinol to conduct strict and automated quality control on each individual stent, ensuring consistently exceptional product quality and safety. Medinol’s EluNIR™ DES was developed to offer clinicians a new generation DES with an optimized stent and delivery system. With more than two million stents delivered globally to date, Medinol’s cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results.