Corvia Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its InterAtrial Shunt Device (IASD) to treat heart failure.
The IASD is claimed to be the world’s first transcatheter device to treat heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction.
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.”
Continuous and dynamic decompression for the left atrium
The company has developed IASD to offer continuous and dynamic decompression for the left atrium, enabling it to minimise symptoms and delay the progression of heart failure.
In September this year, Corvia Medical, in collaboration with physIQ, started a new heart failure (HF) device trial.
The efficacy of IASD is being assessed in REDUCE LAP-HF II multi-national prospective, double-blind and sham-controlled trial. Corvia is currently randomising 608 HFpEF and HFmrEF patients in the US, European Union, Australia, Japan and Canada.
The IASD implant will be placed after the creation of a small opening in the atrial septum. It will help form a passage between the left and right atria, which facilitates the left atrium to decompress at rest and during physical activity.
Through enabling continuous and dynamic decompression of the left atrium, the IASD is said to improve heart failure symptoms and quality of life, as well as decrease heart failure hospitalisation rates and reduce the overall cost to manage heart failure patients.
Corvia Medical quality and regulatory affairs vice president Kate Stohlman said: “The FDA program should accelerate market access and adoption of novel treatments for heart failure patients in the US.”
