Corvia Medical has sponsored and is actively enrolling patients in an innovative heart failure (HF) device trial that, in addition to measuring traditional heart failure endpoints, includes collecting and analyzing biosensor data with physIQ’s continuous remote monitoring platform. The clinical trial is designed to evaluate the clinical efficacy of Corvia’s InterAtrial Shunt Device (IASD®) in patients with heart failure and is enrolling patients at more than 100 sites worldwide. Of note, the pivotal Phase 3 study design mirrors commentary within a recent FDA Public Workshop and FDA Draft Guidance for Industry related to using biosensor data.
“Heart Failure is a major global health problem and HF with preserved and mid-range ejection fraction remains a large unmet need,” said Corvia Chief Medical Officer, Dr. Jan Komtebedde. “At Corvia Medical, we are evaluating a first-in-class approach to treating heart failure and, as such, see a powerful opportunity to include digital data to support IASD efficacy. It’s in this innovative spirit that we chose to partner with physIQ and bring novel real-world insights into how to assess therapeutic impact.”