FDA grants breakthrough status for Accucinch ventricular restoration system
Ancora Heart has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Accucinch ventricular restoration system.
Currently being evaluated in the CORCINCH-HF pivotal clinical trial, the Accucinch system is designed to provide a minimally invasive treatment option for patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF).
“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,” said Ulrich P Jorde (Montefiore Health System, New York, USA) and global co-principal investigator of the CORCINCH-HF Study. “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.”
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