FDAnews Device Daily Bulletin

First Heart Valve That Facilitates Cardiovascular Restoration Implanted in Three Pediatric Patients

Oct. 4, 2016

Xeltis has successfully implanted three pediatric patients with the first heart valve enabling cardiovascular restoration.

The patients have been enrolled in the “Xplore-I” clinical study of Xeltis bioabsorbable pulmonary heart valve, which is studied on patients from 2 to 21 years of age.

The Xeltis technology is an investigational device and is not yet approved for sale. — Cynthia Jessup

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