PARSIPPANY, N.J., Dec. 21, 2016 /PRNewswire-USNewswire/ -- Medinol, a global Interventional Cardiology device company, announced excellent twelve month clinical results from the BIONICS study. The study was conducted to evaluate EluNIR™, Medinol's novel coronary stent system and the first ever elastomer coated drug eluting stent (eDES™). This global pivotal study enrolled 1,919 patients from 76 sites in 8 countries. The BIONICS results were highlighted in the opening Late Breaking Trial session of the 28th annual Transcatheter Cardiovascular Therapeutics (TCT2016) scientific symposium in Washington DC. The study data will be submitted to the FDA to support the U.S. regulatory approval of EluNIR for the treatment of patients with narrowing or blockage of their coronary arteries.
The BIONICS study, a global, prospective, randomized, multicenter, non-inferiority clinical trial was designed to include a "more comers" population, i.e. one that closely represents the real-world patient population. The EluNIR Stent (study name BioNIR™) was compared to the Resolute Integrity™ Stent (1:1 randomization). Key results from the study include:
- For its primary endpoint, Target Lesion Failure (TLF), EluNIR demonstrated a rate of 5.4% at 12 months compared to an identical rate of 5.4% for Resolute (p=0.0013 for non-inferiority). TLF was defined as the composite of cardiac death, target vessel MI, and clinically driven TLR.
- Good safety profile, with a low definite/probable stent thrombosis rate of 0.4% for EluNIR, compared to 0.8% for Resolute (p=NS) with no events beyond 30 days for EluNIR.
"The BIONICS data validated that the EluNIR stent performed very well in a more broad, less selected 'more comers' population than has previously been studied for most other DES," said David Kandzari, M.D., F.A.C.C., Director of Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA and principal investigator for the BIONICS trial. "These results establish the excellent clinical performance of this stent, and we look forward to seeing the angiographic data over the next few months to further support its efficacy."
In addition to the BIONICS study, new twelve-month data from NIREUS, the European pivotal trial for EluNIR, were presented at TCT. The NIREUS study, a prospective, multi-center, randomized, non-inferiority pivotal study comparing EluNIR to the Resolute Integrity Stent, met its non-inferiority primary end point of angiographic in-stent late loss at 6 months. These data were presented at EuroPCR in May 2016. The recent twelve-month clinical data, presented TLF of 3.4% for EluNIR and 5.9% for Resolute (p=NS). These outcomes were consistent with the positive results of BIONICS.
"The BIONICS data are consistent with the excellent results that were demonstrated by EluNIR in NIREUS," said Dr. Yoram Richter, Chief Scientific Officer of Medinol. "In the U.S. alone over 700,000 patients undergo a coronary stenting procedure each year. We are excited to be able to provide them with a new treatment option that has proven outstanding clinical results."
EluNIR is different from other drug eluting stents based on several key traits. EluNIR is coated with an elastomer that maintains a smooth and uniform surface designed to prevent the pro-inflammatory cracking or peeling that may occur with brittle polymers. Furthermore, Medinol manufactures and coats the stent in flat panels utilizing its patented QualitySurface™ technology, ensuring quality, consistency and control over the coating and elution characteristics. EluNIR is coated with ridaforolimus, a "limus" family drug which is intended to prevent restenosis. The stent's design is based on the clinically proven NIRxcell™ stent architecture intended to enhance conformability, scaffolding and radial strength. The delivery system is unique, featuring a distinctive spring tip that is simultaneously more pushable and flexible than the conventional plastic tips used on other delivery systems. EluNIR is currently an investigational device and is not available for commercial sale.
Further information about the EluNIR Stent and the BIONICS trial can be found on the Medinol website.
Medinol LTD, headquartered in Israel, with U.S. Commercial offices in Parsippany, NJ is dedicated to the science of cardiovascular intervention. For over 20 years, its 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, a bare metal stent called NIRxcell™. With over two million stents deployed to date, Medinol's cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results, and their products constantly stretch the limits of innovation. For more information go to www.medinol.com.