CorMatrix Cardiovascular Scores Clearance for Tyke

CorMatrix Cardiovascular has received 510(k) clearance from the FDA for its CorMatrix Tyke, which is derived from the company’s ECM technology platform.

CorMatrix Tyke is intended for use in neonates and infants for the repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defects and annulus repair, suture-line buttressing and cardiac repair.

Early availability of CorMatrix Tyke will begin with up to 15 clinical sites across the U.S. that will take part in a postmarket study. The study is targeted to include up to 150 patients undergoing pediatric cardiovascular procedures. Patients will be enrolled at the time of treatment and monitored at standard follow-up time points with routine collection of data.

Based upon early collection of patient data, the company will eye expanded commercial availability. — Jonathon Shacat