Medinol said yesterday that Japanese regulators approved a clinical trial of its Elunir drug-eluting stent that it plans to add to an ongoing U.S. trial of the device.
The thin-strut, ridaforolimus-eluting Elunir stent (previously known as Bionir) features an elastomeric coating that’s designed to be more flexible than prior-generation polymer coatings. Last month, Medinol presented 1-year data from the 1,900-patient Bionics study, comparing the Elunir/Bionir stent with the zotarolimus-eluting Resolute stent made by Medtronic (NYSE:MDT); Medinol said yesterday that Japan’s Pharmaceutical & Medical Devices Agency granted clinical trial notification for the single-arm, 100-patient JNIR study to confirm Elunir/Bionir’s safety and efficacy in the Japanese clinical environment with a primary endpoint of target lesion failure.
Parsippany, N.J.-based Medinol said it plans to add the JNIR results to the overall results from the Bionics study.
“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,” JNIR principal investigator Dr. Shigeru Saito, of Kanagawa, Japan’s ShonanKamakura General Hospital, said in prepared remarks.
“Medinol strives to develop innovative products that solve complicated cardiovascular problems, and the Elunir stent system is a prime example,” added Medinol chief scientific officer Yoram Richter. “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.”
Twelve-month results from the Bionics study, presented at the annual Transcatheter Cardiovascular Therapies conference in Washington last month, showed identical TLF rates for both the Bionir and Resolute arms, at 5.3%, and similar rates of cardiac death (0.5% vs. 0.2%, respectively), TV-MI (3.1% vs. 3.3%) and ID-TLR (3.0% vs. 2.4%). Definite/probable stent thrombosis was 0.4% for the Bionir device and 0.6% for Resolute. Device success was 98.3% for the ridaforolimus-eluting stent, compared to 99.5% for the zotarolimus-eluting stent.
“One-year clinical outcomes from the Bionics study clearly show that the ridaforolimus-eluting stent was non-inferior to the zotarolimus-eluting stent with identical target lesion failure rates,” principal investigator Dr. David Kandzari, of the Piedmont Heart Institute in Atlanta, said at the time. “In addition, it had a low stent thrombosis rate with no events beyond 30 days.”
Medinol plans to use the Bionics data to back its bid for 510(k) clearance from the FDA.