The FDA Nov. 20 granted BioVentrix breakthrough device designation for its revivent TC transcatheter ventricular enhancement system, used to treat heart failure, according to Medical Device Network.
The device is used to remove scar tissue from the left ventricle caused by a heart attack to allow the healthy part of the heart to function properly. It has implanted micro-anchors that are designed to bring the heart back to a more normal shape and size and minimize wall stress to boost blood flow across the body.
"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." Andrew Wechsler, MD, an emeritus professor at Drexel University told Medical Device Network.
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Editor's Note: This article was updated November 25, 2019 to clarify that BioVentrix did not secure FDA approval for its device.