Corvia Medical said today that it won FDA breakthrough device designation for its interatrial shunt device for heart failure.
The Tewksbury, Mass.-based company’s interatrial shunt 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 the world’s first transcatheter device indicated for diastolic heart failure, also known as heart failure with preserved ejection fraction.
“Receiving breakthrough device designation from the FDA underscores the significant unmet need for more effective treatment options for heart failure patients,” president & CEO George Fazio said in prepared remarks. “We look forward to continuing our work with the FDA through our ongoing pivotal trial in more than 100 hospitals, and providing the clinical evidence which will accelerate the timeline to bring the IASD to the US market.”
“The FDA program should accelerate market access and adoption of novel treatments for heart failure patients in the US,” added VP of quality & regulatory affairs Kate Stohlman. “Demonstrating reduced recurrent heart failure hospitalizations and improved quality of life for these patients, through rigorous clinical trials that generate real evidence, is the company’s primary objective.”
The Reduce LAP-HF II clinical trial of the interatrial shunt was launched in November 2017 and met its primary endpoints in August 2018. Corvia said in September that it expects to complete enrollment in 2020 and, upon conclusion, the company anticipates the study will have generated more than 2 million hours of continuous, annotated, clinical-level physiological data.
Last month, Corvia Medical announced that it launched a trial for the interatrial shunt that will include the collection and analysis of data with PhysIQ’s continuous remote monitoring platform.