IDE Approved for Study of Corvia's Interarterial Shunt Device to Treat Heart Failure

March 7, 2016—Corvia Medical, Inc. announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration for a multicenter study of the company’s IASD, an interatrial shunt device for the treatment of heart failure. The company also announced that it has entered into an exclusive option-to-purchase agreement with an undisclosed strategic partner. 

The REDUCE LAP-HF I study is a prospective, multicenter, randomized controlled study to evaluate the IASD system to reduce elevated left atrial pressure in patients with heart failure with preserved ejection fraction. The study will enroll patients at up to 20 sites in the United States and up to eight sites outside the United States.

After creating a small opening in the atrial septum, the Corvia implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the Corvia system 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. The Corvia IASD atrial decompression system is not available for commercial distribution in the United States, advised the company.

Martin Leon, MD, Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, New York, serves as Chair of the Corvia’s Scientific Advisory Group.

In the company’s press release, Dr. Leon commented, “Treating heart failure patients, especially those with preserved ejection fraction, continues to be a challenge as current pharmacological treatments are ineffective. We expect the results of the REDUCE LAP-HF I randomized study to confirm the significant clinical benefits demonstrated in the observational studies and will show clinically meaningful improvements in New York Heart Association functional class, exercise capacity, and quality of life for this patient population.”