BioVentrix announced the FDA granted it investigational device exemption approval for its Revivent TC transcatheter ventricular enhancement system.
The company has launched a safety and efficacy trial for the system, which is designed to treat ischemic cardiomyopathy. The system eliminates the need for cardiopulmonary bypass or heart incisions, according to BioVentrix.
BioVentrix enrolled the first patient in its trial, with the first procedure performed at Papworth Hospital in the United Kingdom. The company will enroll 120 patients at 20 sites across the U.S. and the UK.