Heart devices developer Corvia Medical has obtained breakthrough device designation from the US Food and Drug Administration (FDA) for its InterAtrial Shunt Device (IASD) in heart failure.
IASD is a transcatheter device to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF), with implantation via a small opening in the atrial septum.
It acts as a passage between the left and right atria to allow the left atrium to decompress at rest and during physical activity, reducing left atrial pressure.
Furthermore, continuous and dynamic decompression of the left atrium could improve heart failure symptoms, enable a better quality of life, minimise hospitalisation rates for heart failure and cut the overall cost burden of heart failure patient management.
Corvia Medical president and CEO George Fazio said: “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.”
The FDA Breakthrough Devices Program offers patients and healthcare providers with timely access to medical devices by accelerating their development, assessment and review.
Corvia Medical quality and regulatory affairs vice-president Kate Stohlman said: “The FDA programme should accelerate market access and adoption of novel treatments for heart failure patients in the US.
“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.”
Currently, the IASD is undergoing a multi-national prospective, double-blind, sham-controlled trial, REDUCE LAP-HF II, in 608 HFpEF and HFmrEF patients across the US, Canada, European Union, Australia and Japan.