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Medical Devices / Submissions and Approvals

Cardiovascular Systems Wins Clearance for Coronary Orbital Atherectomy System in Japan

March 31, 2017

Minnesota–based Cardiovascular Systems has received marketing clearance from Japan’s Ministry of Health, Labor and Welfare (MHLW) for its Diamondback 360 coronary orbital atherectomy system (OAS) micro crown as a treatment for de novo severely calcified lesions and to facilitate access to the arteries for percutaneous coronary interventions (PCI).

The device is designed to pilot tight, calcific lesions and treat up to 4mm vessels.

The Orbit II and Coast studies demonstrated that OAS is safe and effective in treating patients with severely calcified lesions.

The FDA granted marketing clearance for the use of the Diamondback OAS in peripheral arteries in August 2007. In October 2013, the company received FDA clearance for the use of the Diamondback OAS in coronary arteries. — Cynthia Jessup

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