PARSIPPANY, N.J., March 21, 2016 /PRNewswire-USNewswire/ -- Medinol is pleased to announce the enrollment of their first patient in the U.S. NIRTRAKS Study. NIRTRAKS is a post marketing, non-randomized study of the NIRxcell™ Stent System in patients with coronary artery disease indicated for PCI. The study objective is to collect and analyze additional information about the safety and effectiveness of the NIRxcell stent in the treatment of de novo lesions in native coronary arteries in the U.S. population. The data will be collected from 131 patients with a primary endpoint of target vessel failure (TVF) at 3 years. Dr. Manesh Patel, Duke University Hospital, is the national PI for the study with a total of eight sites participating across the U.S. "We are pleased with the start of the NIRTRAKS study, allowing us to gather further data on this unique and highly innovative technology. While we have been utilizing the NIRxcell commercially for the last nine months, we are excited to further understand the clinical application this new design has for our patients," said Dr. Patel, Duke University Hospital.
The first patient was enrolled into the study on January 15, and over the last few weeks, site enrollment has continued to increase. Medinol's Chief Scientific Officer, Yoram Richter, PhD describes the importance of this surveillance study, "We are excited to have the first NIRxcell stents implanted in the NIRTRAKS study. We believe that the NIRxcell bare metal stent, with its advanced cell design and its spring tipped delivery system, is uniquely different from other available products. In PIONIR, a previous prospective study, the stent demonstrated exceptional clinical outcomes including a 5.1% TLR rate at 9 months. We are eager to get further confirmation from interventional cardiologists on the advantages that NIRxcell can offer to their patients".