Corvia Medical has received FDA Breakthrough Device Designation for its Interatrial Shunt Device (IASD) for heart failure. A press release reports that the IASD is the world’s first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction. It is designed to provide continuous and dynamic decompression of the left atrium, which may reduce symptoms and slow the progression of heart failure.
The device is being studied in REDUCE LAP-HF II, a large multinational prospective, double-blind, sham-controlled trial randomising 608 HFpEF and HFmrEF patients in the USA, European Union, Australia, Japan and Canada.
After creating a small opening in the atrial septum, the IASD implant is deployed—forming a passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the IASD aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalisation rates, and reduce the overall cost burden of managing heart failure patients. For more information, please visit http://treatmyheartfailure.com. The IASD is an investigational device and not available for commercial distribution in the United States.
George Fazio, president and CEO of Corvia Medical, says: “Receiving Breakthrough Device Designation from the FDA underscores the significant unmet need for more effective treatment options for heart failure patients. 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.”
Kate Stohlman, vice president of Quality and Regulatory Affairs for the company, comments: “The FDA programme should accelerate market access and adoption of novel treatments for heart failure patients in the USA. Demonstrating reduced recurrent heart failure hospitalisations and improved quality of life for these patients, through rigorous clinical trials that generate real evidence, is the company’s primary objective.”