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Medical Devices / Submissions and Approvals

Abbott Receives European Approval for Two Pediatric Devices

Sept. 19, 2019
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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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