Medinol Receives Approval from The Japanese PMDA to Begin Clinical Study on Novel DES
November 8, 2016
PARSIPPANY, N.J. – Nov. 7, 2016 – Medinol, a developer of Interventional Cardiology devices, announces the receipt of a Clinical Trial Notification (CTN) from the Pharmaceutical and Medical Devices Agency (PMDA) in Japan to initiate its regulatory approval study for EluNIR™ Stent System (known as BioNIR™ in the study), a novel elastomeric Drug Eluting Stent. The study, named JNIR, is designed to confirm the safety and efficacy of EluNIR in the Japanese clinical environment. The expected enrollment will be 100 patients and the results will be added to those from the patients already enrolled in BIONICS, the EluNIR Pivotal Study for FDA clearance.
“This is excellent news for interventional cardiologists in Japan. The unique design features of Medinol’s Drug Eluting Stent System are extremely promising. We are hopeful that the JNIR trial will enable access for cardiology patients to the safest and most efficacious treatment to date,” said Dr. Shigeru Saito, MD, FACC, FSCAI, FJCC, FAPSIC, Director of Cardiology & Catheterization Laboratories and Vice President of Shonan Kamakura General Hospital and the Primary Investigator for JNIR.
The BIONICS clinical trial is a 1:1 randomized study comparing the EluNIR Stent System to Medtronic’s Resolute Integrity™ Stent System and has enrolled 1,919 patients in the U.S., EU, Canada and Israel. The primary endpoint of the study is target lesion failure (TLF), determined at 12 months after the procedure. The twelve month clinical results were presented at TCT 2016 in the opening Late Breaking Trials session on October 30th, and it was announced that EluNIR met its primary endpoint and demonstrated TLF rates of 5.3% compared to 5.3% for Resolute (p=0.0012 for non-inferiority). More details about the BIONICS results are available here. The data will be submitted to the FDA for U.S. approval of EluNIR for the treatment of patients with narrowing or blockage of their coronary arteries.
“Medinol strives to develop innovative products that solve complicated cardiovascular problems, and the EluNIR Stent System is a prime example,” said Dr. Yoram Richter PhD, Chief Scientific Officer of Medinol. “We believe that it will serve as a significant advancement in patient treatment options based on stent and elastomer coating design improvements and overall deliverability. Medinol is excited to introduce EluNIR in Japan so that even more patients around the world will benefit from its technology.”
There are several aspects of the EluNIR stent that differentiate it from other products currently available. EluNIR is coated with an elastomer that maintains a smooth and uniform stent surface designed to prevent the cracking or peeling that may occur with brittle polymers used in other DES. The stent is comprised of cobalt chromium and manufactured and coated in flat panels utilizing Medinol’s patented QualitySurface™ Technology and contains the drug Ridaforolimus, a Rapamycin analog, intended to prevent restenosis. The EluNIR 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 conventional plastic tips used on other delivery systems. EluNIR is an investigational device and is not available for commercial sale.