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Medical Devices / Submissions and Approvals

Abbott Receives European Approval for Two Pediatric Devices

Sept. 19, 2019

Abbott’s Masters HP 15mm rotatable mechanical heart valve and Amplatzer Piccolo Occluder have both received the CE Mark.

The Masters HP product is a miniature mechanical heart valve designed to treat babies and toddlers that require mitral or aortic heart valve replacements. The Amplatzer Piccolo is a device that can be implanted in babies weighing under a kilogram to treat patent ductus arteriosus, a life-threatening opening in the heart.

The devices have already received FDA clearance and are the first of their kind to treat the congenital heart defects, the company said.

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