Medinol has completed patient enrollment in its NIRflex U.S. clinical trial to collect information about the safety and efficacy of a next generation premounted stent system; the NIRflex. Eleven investigational sites have registered 201 patients nearly two months ahead of schedule.
"Our revolutionary NIRflex coronary and peripheral stents simultaneously provide continuous scaffolding and exceptional flexibility, optimizing the performance of the stent," says Dr. Judith Richter, founder and chief executive officer of Medinol. "The unique NIRflex stent design provides advantages over other stents by continually conforming to the vessel while maintaining optimal scaffolding, even as the vessel moves." NIRflex and NIRflex Royal premounted stents received the CE mark in March 2002 and are marketed and sold in Europe through distributors.
Completion of patient enrollment in the NIRflex U.S. clinical trial is a key milestone for Medinol toward receiving US FDA approval for the NIRflex premounted stent system.
"The NIRflex stent design represents a major advancement in the NIR technology. The device performance in terms of deliverability and angiographic appearance is outstanding," says Dr. Jeffery Moses, a leading investigator of the NIRflex US clinical trial. "Medinol's innovation and expertise will continue to move the industry standard forward and provide improved care to cardiac patients and cardiologists around the world."
Results from one-month clinical follow-up are expected in September, followed by six-month clinical follow-up. Medinol expects to submit the PMA toward the end of the third quarter 2002 and to receive PMA approval by the end of first quarter 2003.
Medinol is concurrently completing six months of angiographic follow up in its worldwide NIR TOP trial, the first trial conducted with Medinol's NIRflex and NIRflex Royal stents premounted on Medinol's own delivery system. The NIR TOP clinical trial was designed to compare the acute and long-term results between the two products. The preliminary 30-day results will be shared at the Transcatheter Cardiovascular Therapeutics conference on September 24 to 28, 2002, in Washington, D.C.
Medinol says the potential of the stent market in the USA is an estimated $ 1.4 billion.
Published by Globes [online] - www.globes.co.il - on 18 August 2002