TEWKSBURY, MA – Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its InterAtrial Shunt Device (IASD®) for heart failure. The IASD® is the world’s first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction.
“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.”
– George Fazio, President and CEO, Corvia Medical
What is Breakthrough Device Designation?
FDA Breakthrough Device designation is granted to medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program intends to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, clearance of a premarket notification (510(k)), and marketing authorization via the De Novo classification process.
The IASD® 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 multi-national prospective, double-blind, sham-controlled trial randomizing 608 HFpEF and HFmrEF patients in the United States, European Union, Australia, Japan and Canada. Recruitment is ongoing.
“The FDA program should accelerate market access and adoption of novel treatments for heart failure patients in the US. 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.”
– Kate Stohlman, VP of Quality and Regulatory Affairs, Corvia Medical
About Heart Failure
There are two types of heart failure: heart failure with reduced ejection fraction (HFrEF), also called systolic heart failure, and heart failure with preserved or mid‐range ejection fraction (HFpEF/HFmrEF), previously called diastolic heart failure. Ejection fraction (EF) is a measurement of how well blood is pumped out of the heart during a single contraction and is noted as a percentage, with a normal range between 50%-75%, whereas mid-range is between 40%-50%). HFpEF and HFmrEF occur when the muscles of the left ventricle become stiff and are unable to relax normally. As a result, it cannot fill properly. This means the pressure inside the left heart chambers and the lungs increases. Medicines that are effective for treating the other type of heart failure (HFrEF) frequently do not work well for HFpEF or HFmrEF and treatment options are currently very limited.
About the InterAtrial Shunt Device (IASD®)
The InterAtrial Shunt Device is the world’s first transcatheter device to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). 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 hospitalization rates, and reduce the overall cost burden of managing heart failure patients. For more information visit http://treatmyheartfailure.com. The IASD® is an investigational device and not available for commercial distribution in the United States.
About Corvia Medical, Inc.
Corvia Medical, Inc. is dedicated to revolutionizing the treatment of heart failure with first-in-class transcatheter structural heart devices. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences and an undisclosed strategic investor.