CorMatrix Cardiovascular said today that it won CE Mark approval in the European Union for its CanGaroo ECM surgical envelope for implanted cardiac devices.
Roswell, Ga.-based CorMatrix won 510(k) clearance from the FDA in August 2014 for the CanGaroo device, which is designed to act as a scaffold to stimulate natural wound healing using CorMatrix’s extra-cellular matrix. The CanGaroo envelope is meant to be used with implanted pacemakers and ICDs.
“With data trending toward increases in the number of implants in Europe, we’re excited to make this device available to the Electrophysiology communities of Europe,” president & COO Andrew Green said in prepared remarks.
