Bioventrix’s Transcatheter Heart Device Gains FDA Breakthrough Status

The FDA has granted breakthrough device designation status to Bioventrix’s Revivent TC, a transcatheter-based structural heart device, for treating heart failure.

The device is used during less invasive ventricular enhancement (LIVE) procedures to exclude scar tissue in the left ventricle caused by a heart attack, allowing the healthy part of the heart to function more effectively.

During the procedure, anchors are placed and set to shape the heart into a more normal form and size, taking stress off its walls and potentially improving blood flow through the body.