Transcatheter HF device receives breakthrough designation from FDA

The FDA has granted Breakthrough Device status to BioVentrix, Inc.’s Revivent TC Transcatheter Ventricular Enhancement System, a proactive approach to treating MI-induced heart failure.

BioVentrix claims the Revivent TC separates anterior scarred myocardium from viable heart tissue, reduces wall tension and restores conical morphology in hearts damaged by heart attacks. The idea is to eradicate any scarred tissue on the left ventricle so hearts can function more smoothly.

The Revivent TC System is implemented during a procedure known as the Less Invasive Ventricular Enhancement, or LIVE, procedure. During the intervention, micro-anchors are implanted and designed to remodel the heart to a “more normal” shape and size as well as reducing wall stress, which can improve blood flow throughout the body.

“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,” Andrew Wechsler, MD, of the Drexel University College of Medicine, said in a release Nov. 19. Wechsler is the principal investigator for the ALIVE U.S. IDE trial, which is in the process of enrolling patients and will test the efficacy of the Revivent TC.

“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.”

ALIVE will enroll up to 120 patients at up to 20 sites in the U.S., with a primary analysis endpoint at one year. The Revivent TC System has already received a CE Mark, making it commercially available in Europe, and the FDA’s Breakthrough Device designation will likely speed up the approval process in the U.S.