BioVentrix Secures FDA IDE Approval to Begin Clinical Trial
San Ramon, Calif.-based BioVentrix has received FDA investigational device exemption approval to conduct a clinical trial evaluating the safety and effectiveness of its Revivent TC transcatheter ventricular enhancement system.
The system is designed to treat patients suffering from ischemic cardiomyopathy through left ventricle restoration.
The trial will involve 120 patients at up to 20 sites nationwide. Trial endpoints include positive effects on volume reduction, ejection fraction and quality of life after one year. — Anisa Jibrell