FDA has approved Ancora Heart’s IDE application for the CorCinch-HF pivotal study.
The Santa Clara, CA-based company said 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).
During the AccuCinch procedure, an implant is placed into the mid-left ventricular wall, the implant is then cinched. Once cinched, the implant is intended to reduce the size of the left ventricle, as well as support and strengthen the heart wall to help improve left ventricular function. The AccuCinch System is designed to provide extra stability and support to the left ventricular wall. This may lower stress on the heart and allow improved functional capacity and quality of life for patients.
Ancora Heart touted the study’s design, which will allow an initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached twelve months of follow-up. The study will ultimately follow patients through five years post-treatment to track long-term results.
Jeff Closs, president and CEO of Ancora Heart said the company worked closely with FDA on the design and said the result was a testament to the agency’s “collaboration” and “flexibility.”
“For heart failure patients symptomatic relief is a big deal,” Closs told MD+DI. “They just want to feel better. They want to have a better quality of life, they want to be able to have more exercise capacity and if you do a lot of polling of patients living longer isn’t necessarily at the top of the list. At the top of the list is they just want to feel better when they wake up every day. What FDA has realized is that symptomatic improvement is very important.”
He added, “the first phase is to really demonstrate that we can improve day-to-day quality of life for these heart failure patients. We would then submit for a PMA approval for that indication of symptomatic improvement. "
Closs said there are two different endpoints Ancora Heart is looking at. The first allows an earlier PMA submission for symptomatic relief and a later phase of a larger sample size allows the firm to evaluate the mortality and hospital benefit.
Ancora Heart hasn’t gone untouched by COVID-19. The company said that procedures had to be delayed because of the pandemic. The firm said it expects to be back into clinicals in the August or September timeframe.
“We’ve clearly seen an impact [from COVID-19] on our ability to perform procedures,” said. “A lot of elective and research projects have been put on hold. So, our enrollment in our early feasibility studies and our CE mark study have been impacted by our inability to travel and the hospitals’ prioritization on COVID-related care.”
He added, “What’s interesting is that we continue to enroll patients in the study,” he said. “In June, we had a number of new consented and enrolled patients in our study.”