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BioVentrix Gains FDA Breakthrough Device Designation for their Revivent TC Transcatheter Ventricular Enhancement System

November 20, 2019

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BioVentrix, Inc., a privately-held company with a first-in-class, transcatheter-based structural heart device to treat heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation status for its Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure.

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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.

“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 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 received the CE Mark and is commercially available in Europe.

“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.”

The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the Agency’s mission to protect and promote public health.

See: Full Press Release FDA Grants Breakthrough Device Designation Status for BioVentrix Revivent TC Transcatheter Ventricular Enhancement System for Heart Failure | Business Wire

Written by: BioVentrix

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