BioVentrix, Inc., a privately-held company with a first-in-class, transcatheter-based structural heart device to treat heart failure, has been granted Breakthrough Device Designation status for its Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure.
The goal of the U.S. FDA’s Breakthrough Devices Program is to provide patients and health care providers with timely access to new medical devices by speeding up their development, assessment, and review, while preserving the Agency’s mission to protect and promote public health. It applies to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Less Invasive Ventricular Enhancement, or the 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.
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 Revivent TC system has received the CE Mark and is commercially available in Europe.
“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,” said Principal Investigator for the ALIVE U.S. IDE trial of the Revivent TC System, Andrew Wechsler, MD, of the Drexel University College of Medicine. “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.”
“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,” said BioVentrix CEO Ken Miller. “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.”
Source: BioVentrix, Inc.