LV implant to treat symptoms of resistant HFrEF nets FDA breakthrough device designation
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Ancora Heart Inc. announced that the FDA granted breakthrough device designation to its transcatheter left ventricular implant to improve LV structure and function in patients with HF with reduced ejection fraction.
The implant (AccuCinch ventricular restoration system) is designed to reduce the size of the left ventricle, reduce ventricular wall stress and strengthen the heart wall in patients with HFrEF who remain symptomatic despite guideline-directed medical care, according to a company press release.
Breakthrough therapy designation is designed to expedite the development and review of therapies that are intended to treat a serious condition in which preliminary clinical evidence indicates potentially substantial improvement over available therapies on a clinically significant endpoint.
The implant is the only completely transcatheter procedure designed to treat the enlarged left ventricle and is currently being tested in the CORCINCH-HF pivotal clinical trial, according to the release.
“The chronic and progressive nature of heart failure leaves many patients to face an increasingly challenging future as existing treatments, including medications and pacemaker devices, are not able to keep the disease at bay,” Ulrich P. Jorde, MD, professor of medicine at the Albert Einstein College of Medicine, section head of heart failure, cardiac transplantation and mechanical circulatory support at Montefiore Health System in New York and co-principal investigator of the CORCINCH-HF trial, said in the release. “Early data on the AccuCinch system are promising, providing hope that this novel transcatheter approach may address the therapeutic gap for heart failure patients in the future.”
Reference:
- Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study. https://clinicaltrials.gov/ct2/show/NCT04331769?term=ancora+heart&cond=heart+failure. Published April 2, 2020. Accessed July 12, 2022.
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