Medinol Enrolls a First-in-Human Study of ChampioNIR® SFA Stent System
April 5, 2020
APRIL 2020, Tel-Aviv, Israel – Medinol announces enrollment in its ChampioNIR® First-in-Human trial. A prospective, multicenter, single-arm, open-label clinical trial, to assess the safety and efficacy of the ChampioNIR® SFA stent system in the treatment of patients with Superficial Femoral Artery disease.
The ChampioNIR-FIH trial will enroll 30 patients at 4 sites in Israel, with the goal to collect and analyze information about the feasibility, safety and efficacy of implantation of the ChampioNIR® stent in the superficial femoral artery (SFA).
The primary safety endpoint of the ChampioNIR-FIH study is the composite rate of freedom from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days. The primary efficacy endpoint is patency of the target lesion at 6 months.
“The superficial femoral artery is subject to extreme and constant mechanical forces. Traditional peripheral stents are known to be prone to fracture, leading to re-occlusion”, said Medinol’s Chief Scientific Officer, Yoram Richter, PhD., “The unique characteristics of the ChampioNIR® stent combine high radial strength with a virtually infinite fatigue resistance. This study will allow us to validate ChampioNIR® as the first peripheral stent to offer a viable durable solution for long-term stenting of peripheral arteries”.
ChampioNIR® is Medinol’s SFA hybrid stent device, combining Nitinol alloy structure with an elastomeric micro-fiber mesh. This unique combination allows for simultaneous vessel support, unparalleled fatigue resistance and the ability for millimeter-level precision deployment of ultra-long scaffolds that conform to the vessel’s natural form and motion.
Medinol 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 both in the peripheral and the coronary stent market, and a long, established history in the in the coronary 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. All Medinol’s interventional 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.