Image courtesy of Medinol
March 24, 2016 — Medinol announced 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 percutaneous coronary intervention (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 three years. Manesh Patel, M.D., Duke University Hospital, is the national principal investigator (PI) for the study with a total of eight sites participating across the United States.
"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 Patel.
The first patient was enrolled into the study on Jan. 15, and over the last few weeks, site enrollment has continued to increase.
The NIRTRAKS study will look to build on the results of the PIONIR prospective study, which saw the NIRxcell stent demonstrate a 5.1 percent target lesion revascularization (TLR) rate at nine months, according to Medinol’s Chief Scientific Officer Yoram Richter, Ph.D.
The NIRxcell Stent is Medinol's fifth-generation coronary stent. It features the 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 United States in January 2015.
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.
For more information: www.medinol.com