USFDA grants Breakthrough Device Designation for BioVentrix’s Revivent TC system

20 November 2019 (Last Updated November 25th, 2019 10:27)

BioVentrix, a US-based a privately-held medical device company, has secured Breakthrough Device Designation status from the US Food and Drug Administration (FDA) for its Revivent TC  Transcatheter Ventricular Enhancement System to treat heart failure.

USFDA grants Breakthrough Device Designation for BioVentrix’s Revivent TC system
Revivent TC System is used to remove scar tissue on the left ventricle. Credit: Patrick J Lynch, medical illustrator.

US-based a privately held medical device company BioVentrix has secured Breakthrough Device Designation status from the US Food and Drug Administration (FDA) for its Revivent TC  Transcatheter Ventricular Enhancement System to treat heart failure.

For the Less Invasive Ventricular Enhancement (LIVE)  procedure, Revivent TC System is used to remove scar tissue on the left ventricle due to heart attack to enable efficient functioning of the healthy part of the heart.

The implanted micro-anchors are designed to bring back the heart to a more normal shape and size, minimising wall stress to boost blood flow across the body.

Drexel University College of Medicine cardiothoracic surgery department emeritus professor Andrew Wechsler said: “Heart failure continues to be an epidemic and the BioVentrix technology addresses a potentially curable cause of heart failure, which is precipitated by scarring of the left ventricle from a prior heart attack.

“Current methods for surgical remodelling of the ventricle are effective but highly invasive, and not well tolerated by patients. Having a less invasive method to treat the ventricle enables more patients to benefit from a more efficient heart.”

Currently, the ALIVE Trial of the Revivent TC System is enrolling up to 120 patients at up to 20 locations in the US. This trial has a primary endpoint analysis at one year.

This system has secured the CE Mark and is now available in Europe.

BioVentrix CEO Ken Miller said: “The breakthrough designation for the Revivent TC System recognizes that many patients suffering from heart failure are at risk of death without a less invasive way to address their left ventricular damage.

“Being part of the Breakthrough Devices Program should help to speed the FDA’s evaluation and ultimately, market-entry, so more patients can be helped more quickly.”