FDA grants breakthrough device designation for heart treatment system

Heart device company BioVentrix has received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its Revivent TC Transcatheter Ventricular Enhancement System for heart failure.

Less Invasive Ventricular Enhancement (LIVE) procedure, uses the Revivent TC System to exclude scar tissue on the left ventricle that has resulted from a heart attack so the healthy portion of the heart can function more efficiently. Micro-anchors are implanted and designed to remodel the heart to a more normal shape and size and reduce wall stress, which has the potential to improve blood flow throughout the body.

Principal investigator for the ALIVE U.S. IDE trial of the Revivent TC System, Andrew Wechsler, of Drexel University College of Medicine, 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.”

The U.S. pivotal ALIVE Trial of the Revivent TC System is currently enrolling up to 120 patients at up to 20 U.S. sites with a primary endpoint analysis at one year. The system has also received the CE Mark.

BioVentrix CEO Ken Miller said: “The breakthrough designation for the Revivent TC System recognises 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.”