Ancora Heart announced today that it received FDA investigational device exemption (IDE) for its AccuCinch ventricular restoration system.
AccuCinch is designed to treat patients with heart failure and reduced ejection fraction (HFrEF) by directly reshaping the left ventricle of the heart to address the fundamental issue in the progression of systolic heart failure, according to a news release.
Garnering IDE allows for Ancora Heart to go ahead with its CorCinch-HF pivotal study, which is set to evaluate the safety and efficacy of the AccuCinch system in HFrEF patients.
The prospective, randomized, open-label, multicenter, international clinical safety and efficacy investigation of the AccuCinch system is set to enroll 400 patients at up to 80 centers worldwide. It allows for initial analysis for premarket approval submission after the first 250 patients reach six months of follow-up, then a second analysis after the entire cohort reaches 12 months. The study will ultimately follow patients through five years post-treatment to track long-term results.
“The approval of the IDE for the CorCinch-HF pivotal trial represents a major milestone as we continue to gather data to evaluate the safety and effectiveness of the AccuCinch System,” Ancora Heart president & CEO Jeff Closs said in the news release. “We look forward to working with study sites to initiate patient enrollment as soon as possible.”