Medinol's JNIR Study of EluNIR DES Approved in Japan

November 7, 2016—Medinol, Ltd. announced the receipt of a Clinical Trial Notification from Japan’s Pharmaceutical and Medical Devices Agency to initiate its regulatory approval study for the EluNIR elastomeric ridaforolimus-eluting stent system (known as BioNIR in the study).  

According to the company, the JNIR study 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 US Food and Drug Administration (FDA) clearance of the device in the United States. EluNIR is an investigational device and is not available for commercial sale.

Shigeru Saito, MD, is the Primary Investigator for the JNIR study. Dr. Saito commented in the company’s press release, “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.” Dr. Saito is Director of Cardiology & Catheterization Laboratories and Vice President of Shonan Kamakura General Hospital in Kamakura, Japan.

The BIONICS clinical trial is a 1:1 randomized study comparing the EluNIR stent system to the Resolute Integrity stent system (Medtronic plc). BIONICS has enrolled 1,919 patients in the United States, European Union, Canada, and Israel. The primary endpoint of the study is target lesion failure (TLF), determined at 12 months after the procedure.

Medinol advised that the 12-month clinical results were presented on October 30 during a Late Breaking Trials session at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington. DC. EluNIR met its primary endpoint and demonstrated TLF rates of 5.3% compared to 5.3% for Resolute (P = .0012 for noninferiority). The data will be submitted to the FDA for approval of EluNIR in the United States for the treatment of patients with narrowing or blockage of coronary arteries.