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Japan Green Lights Medinol Stent Trial

November 9, 2016

Japanese regulators approved a clinical trial of Medinol’s Elunir drug-eluting stent.

The thin-strut, ridaforolimus-eluting Elunir stent (previously known as Bionir) has an elastomeric coating that’s designed to be more flexible than prior-generation polymer coatings.

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. — Cynthia Jessup

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