PARSIPPANY, N.J., - 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”.
The NIRxcell Stent is Medinol's fifth generation coronary stent. It features the unique WiZeCell™ stent design, offering an optimal balance between vessel conformability, scaffolding integrity and radial strength. The Flexx2™ delivery system with a spring tip ensures ease of delivery even in the most tortuous and calcified anatomies. NIRxcell became commercially available in the U.S. in January 2015, and in a short period of time found its way into 40+ large hospitals across the country. NIRxcell Stent technology serves as a platform for Medinol’s eDES™ (elastomer drug-eluting stent) currently in clinical trials in the U.S., Canada, Europe and Israel.
Medinol, headquartered in Israel, with U.S. Commercial offices in Parsippany, NJ is dedicated to the science of cardiovascular intervention. For over 20 years, Medinol's in-house research, development, and manufacturing have continuously raised the bar for quality and performance of stenting systems. With over two million stents deployed to date, their cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results, and their products constantly stretch the limits of innovation. For more information go to www.medinol.com.