FDA Grants Breakthrough Status to Heart Failure Tech

Samara Rosenfeld
NOVEMBER 19, 2019
heart
Photo/Thumb have been modifed. Courtesy of bluebay2014 - stock.adobe.com.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to BioVentrix for its Revivent TC Transcatheter Ventricular Enhancement System for heart failure.

The Less Invasive Ventricular Enhancement procedure uses Revivent TC to exclude scar tissue on the left ventricle that has resulted from a heart attack. This allows the healthy portion of the heart to work more efficiently.

“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 Andrew Wechsler, M.D., principal investigator for the ALIVE U.S. IDE trial of the Revivent TC System.

Current repairing of the ventricle is highly invasive and can be painful or intolerable for patients, Wechsler said.

“Having a less invasive method to treat the ventricle enables more patients to benefit from a more efficient heart,” he said.

Using the Revivent TC System, micro-anchors are implanted and designed to remodel the heart to a more normal size and shape which could help improve blood flow.

The ALIVE Trial is enrolling up to 120 patients at up to 20 U.S. sites with a primary endpoint analysis at one year. The trial was initiated for the treatment of symptomatic heart failure patients with damage to the left side of the heart. Measures of the trial include hospital readmissions and improvement of the quality of life score, six-minute walk distance test and New York Heart Association Classification score.

“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 Ken Miller, MBA, president and CEO at BioVentrix. “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.”

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