Medinol said it enrolled the 1st U.S. patient in a post-market study of its bare-metal NIRxcell stent, which has been on the U.S. market since January 2015.
Tel Aviv-based Medinol said the NIRxcell stent is a 5th-generation stent using its WiZeCell design and the Flexx2 spring-tip delivery catheter. The device 1st won pre-market approval from the FDA in December 2013.
Medinol, which has its U.S. headquarters in Parsippany, N.J., said the 131-patient Nirtraks study is a single-arm, non-randomized trial with a primary endpoint of target vessel failure at 3 years. The 1st patient in the 8-site trial enrolled in January, the company said.
“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% [target lesion revascularization] rate at 9 months. We are eager to get further confirmation from interventional cardiologists on the advantages that NIRxcell can offer to their patients,” chief scientific officer Yoram Richter said in prepared remarks.
“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,” added principal investigator Dr. Manesh Patel of the Duke University Hospital.
Medinol said the NIRxcell technology is the platform for the elastomer drug-eluting stent it has in trial in the U.S., Canada, Europe and Israel.