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Medical Devices / Submissions and Approvals

Japan Approves Coronary Orbital Atherectomy Device

Jan. 3, 2019

Japan’s Ministry of Health, Labor and Welfare approved Cardiovascular Systems’ Diamondback 360, a coronary orbital system for removing sclerosis from blood vessels.

The device facilitates stent delivery in coronary artery disease patients who are eligible to receive stenting or coronary angioplasties.

The Diamondback 360 uses centrifugal force and differential sanding to reduce calcium in a patient’s arteries and enable successful stent delivery.

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