Medinol has announced that the BioNIR has met its non-inferiority primary end point of angiographic in-stent late loss at six months in the NIREUS trial. The prospective, multicentre, randomised, non-inferiority pivotal study compared it to Medtronic’s Resolute Integrity stent.
The BioNIR is an elastomeric drug eluting coronary stent system. 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.
The BioNIR stent demonstrated a low late loss result of 0.04+/-0.31mm (n=201) compared with 0.03+/-0.31mm 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 six months compared with 3% for Resolute Integrity (p=NS). The results were unveiled during the EuroPCR 2016 conference in Paris, France.
“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,” says Pieter C Smits of Maasstad Ziekenhuis, Rotterdam, The Netherlands, principal investigator for the NIREUS trial. Smits further commented on the BioNIR stent’s angiographic appearance: “The stent conforms well to the vessel, and provides consistent, smooth scaffolding.”
“The BioNIR stent is innovative in the way it is made, as well as in its use of novel elastomeric materials,” says 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 NIRxcell stent architecture intended to enhance conformability, scaffolding and radial strength while the delivery system features a spring tip that is designed to be 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 designed to maintain a smooth and uniform stent surface designed to prevent pro-inflammatory cracking and peeling.