Corvia Medical today released 1-year results from the Reduce LAP-HF clinical trial of its InterAtrial shunt device, touting a good safety profile and sustained device performance.
Results from the 64-patient study was presented at the American Heart Association’s 2016 Scientific Sessions.
The Tewksbury, Mass.-based company’s IASD is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s indicated for diastolic heart failure, also known as heart failure with preserved ejection fraction.
Data from the trial indicated a median New York Hear Association functional class improvement from 3 to 2, while the mean quality of life score, as rated by the Minnesota Living with Heart Failure questionnaire, improved from 49 to 34. Mean 6-minute walk distance also improved from 331 meters to 363 meters.
“Patients with heart failure in the context of preserved ejection fraction currently have few, if any, effective treatment options. As such, there is a major unmet clinical need for effective approaches to improve the quality of lives of these patients. Elevated left atrial pressures are a key contributor to heart failure symptoms. The Corvia IASD System is designed to facilitate continuous and dynamic decompression of the left atrium to improve exercise capacity and quality of life for patients with HFpEF. The compelling one-year data demonstrating sustained benefit shows the clear promise of this breakthrough technology,” David Kaye of Melbourne, Australia’s The Alfred Hospital said in prepared remarks.
“The presentation of this one-year data at AHA is another exciting milestone for Corvia. We are encouraged that the longer-term follow-up continues to demonstrate statistically significant, and even more importantly, clinically-meaningful results as we aim to improve the lives of patients around the world who suffer from heart failure,” chief medical officer Jan Komtebedde said in a press release.
In May, Corvia said it landed CE Mark approval in the European Union for its InterAtrial Shunt device for treating a type of heart failure.