PARSIPPANY, N.J. and TEL AVIV, Israel, May 17, 2016. Medinol announced outstanding results from the NIREUS trial for BioNIR™, its new coronary stent system and the first ever elastomeric Drug Eluting Stent or eDES™. NIREUS is a prospective, multi center, randomized, non-inferiority pivotal study comparing Medinol's BioNIR to the Resolute Integrity™ Stent. The study enrolled 302 patients with coronary artery disease at 31 sites in Europe and Israel and will be used to support Medinol's submission for CE mark.
NIREUS met its non-inferiority primary end point of angiographic in-stent late loss at 6 months. The BioNIR stent has demonstrated an exceptionally low late loss result of 0.04+/-0.31 mm (N=201) compared with 0.03+/-0.31 mm for Resolute Integrity (N=101) with a high degree of statistical significance (p<0.0001). In addition, the BioNIR stent demonstrated a Target Lesion Failure rate of 1.5% at 6 months compared with 3.0% for Resolute Integrity (p=NS). The results were unveiled during the EuroPCR 2016 conference in Paris.
"We are very enthusiastic about the NIREUS results, particularly with the remarkably low in-stent late loss. These uncommonly good clinical results will help increase physician confidence in the long term benefits of the BioNIR stent for patients," said Pieter C. Smits, MD, PhD, at Maasstad Ziekenhuis, Rotterdam, The Netherlands, principal investigator for the NIREUS trial. Dr. Smits further commented on the BioNIR stent's angiographic appearance: "The stent conforms well to the vessel, and provides consistent, smooth scaffolding. This is all very exciting, and we look forward to following these patients to see how these excellent outcomes progress over time."
"The BioNIR stent is innovative in the way it is made, as well as in its use of novel elastomeric materials," said Dr. Yoram Richter, Chief Scientific Officer of Medinol. "Together, these ensure that the coating maintains its long-term integrity and uniform surface, through expansion and drug elution. This has the effect of lowering inflammation and distributing a controlled and uniform dose of drug to the vessel wall."
BioNIR is based on the clinically proven NIRxcell™ stent architecture intended to enhance conformability, scaffolding and radial strength while the delivery system features a distinctive spring tip that is simultaneously more pushable and flexible than the plastic tips used on other stent delivery systems. The stent is comprised of cobalt-chromium and elutes ridafarolimus, a "limus" family drug, intended to prevent restenosis. It is coated with an elastomer that maintains a smooth and uniform stent surface designed to prevent the pro-inflammatory cracking and peeling that occurs with brittle polymers used in other drug eluting stents. The BioNIR Stent System is an investigational device and is not available for commercial sale.
Medinol Ltd., headquartered in Israel, with US offices in Parsippany, NJ is dedicated to the science of cardiovascular intervention. For over 20 years, our in-house research, development, and manufacturing have continuously raised the bar for quality and performance of stenting systems. In 2014 Medinol established its first sales office in the US and launched its first product sold directly to hospitals, the NIRxcell™ bare metal stent. With over two million stents deployed to date, Medinol's cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results, and its products constantly stretch the limits of innovation. For more information go to www.medinol.com