Ancora Heart has received investigational device exemption (IDE) application approval from the US Food and Drug Administration (FDA) for its CorCinch-HF pivotal study.
The study is designed to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
The AccuCinch System is a percutaneous device developed to reshape the left ventricle of the heart directly. It is designed to improve and complement the current care offered by cardiologists to manage symptoms and slow or stop the progression of heart failure.
Minimally invasive percutaneous device therapy with the AccuCinch System is expected to offer an effective treatment option for patients whose heart failure has progressed beyond the ability of medications and pacemakers to manage symptoms.
The CorCinch-HF pivotal study is being planned as a prospective, randomised, open-label, multicenter, international investigation that will enrol 400 patients at approximately 80 centres globally.
Ancora Heart president and CEO Jeff Closs said: “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.
“We look forward to working with study sites to initiate patient enrolment as soon as possible.”
The unique design of the CorCinch-HF pivotal study will enable an initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up. It will be followed by a second analysis after the entire cohort reaches twelve months of follow-up.
It will ultimately follow patients through five years post-treatment to track long-term results, the company noted.