November 18, 2019
BioVentrix's Revivent TC System Receives FDA Breakthrough Device Designation
November 19, 2019—BioVentrix, Inc. announced that the FDA has granted Breakthrough Device designation status for the company’s Revivent TC transcatheter ventricular enhancement system for heart failure.
According to the company, the Revivent TC is used during the less invasive ventricular enhancement (LIVE) procedure to exclude left ventricular scar tissue postmyocardial infarction and improve heart function by using implanted microanchors to cinch together the scarred area and reduce wall stress.
The device will be studied in the pivotal ALIVE trial, which is currently enrolling up to 120 patients at up to 20 sites in the United States, with a primary endpoint analysis at 1 year.
“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,” commented ALIVE Principal Investigator Andrew Wechsler, MD. “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.” Dr. Wechsler is with the Drexel University College of Medicine in Philadelphia, Pennsylvania.
The Revivent TC system has CE Mark approval and is commercially available in Europe.
The company advised that the FDA Breakthrough Devices program is intended to help patients receive timely access to technologies that treat or diagnose life-threatening or debilitating diseases and conditions by speeding up the devices’ assessment, review, and market entry—while preserving the FDA’s mission to protect and promote public health.