BioVentrix has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Revivent TC transcatheter ventricular enhancement system for heart failure.

Revivent TC system will be used in the less invasive ventricular enhancement (LIVE) procedure to exclude scar tissue on the left ventricle resulted from a heart attack, helping in the efficient functioning of the healthy portion of the heart.

Micro-anchors, which can be implanted, have been designed to remodel the heart to a more normal shape and size and decrease wall stress. It will help in the improvement of blood flow across the body.

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.

The company is currently recruiting up to 120 patients in the US pivotal Alive trial with a primary endpoint analysis at one year. The patients will be recruited at up to 20 sites in the US.

The Revivent TC system is already commercially available in the Europe

In 2016, BioVentrix secured CE mark approval for Revivent TC system. It is commercially available in the Europe.

Alive US IDE trial principal investigator Dr 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 remodeling 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.”

Based in San Ramon of California, BioVentrix aims to provide improved treatment for congestive heart failure (CHF) caused by ischemic cardiomyopathy through the development of less invasive, catheter-based approaches.