BioVentrix announced today that it won FDA breakthrough device designation for its Revivent TC transcatheter ventricular enhancement system for heart failure.
The Revivent TC system is used in less invasive ventricular enhancement (LIVE) procedures intended to exclude scar tissue on the left ventricle that resulted from a heart attack so that the healthy portion of the heart can function more effectively.
In the procedure, micro-anchors are implanted, having been designed to remodel the heart to a more normal shape and reduce wall stress, improving blood flow.
Currently, BioVentrix is enrolling up to 120 patients at up to 20 U.S. sites with a primary endpoint analysis at one year for its Alive pivotal trial of the Revivent TC system. The system is already 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,” BioVentrix CEO Ken Miller said in a news release. “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.”
“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,” added Alive trial principal investigator Dr. Andrew Wechsler 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 company enrolled its first U.S. Revivent TC patient in October 2017. This year, the company pulled in a $22 million funding round in April, followed by an $18 million round in July. In February of this year, BioVentrix said that it won renewed German reimbursement for the Revivent TC system.
In October, BioVentrix announced that it enrolled and treated the first patient in its Revive-HF 180-patient European trial comparing the Revivent TC system to guideline-directed medical therapy or drug treatment. The company said the primary endpoint of the trial will be improvement in heart failure symptoms based on a six-minute walking test. The company estimates a primary completion date of Dec. 31, 2020 and a study completion date of Dec. 31 2022, according to ClinicalTrials.gov.
