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Medical Devices / Submissions and Approvals

FDA Grants Clearance to BioStable Science & Engineering’s Aortic Annuloplasty Device

March 23, 2017

BioStable Science & Engineering has received FDA market clearance for its HAART 300 aortic annuloplasty device.

The device is designed to re-size, reshape and stabilize the aortic annulus to restore valve competence and help prevent recurrent aortic regurgitation.

The device received CE Mark approval in 2016. — Cynthia Jessup

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