This article is more than 5 years old. Information may no longer be current.

FDA approves new study of transcatheter device for HF

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Corvia Medical has received Investigational Device Exemption approval from the FDA to conduct a multicenter study of a transcatheter structural heart device for the treatment of HF.

REDUCE LAP-HF I is a prospective, multicenter, randomized, controlled study designed to evaluate the InterAtrial Shunt Device (IASD) System to reduce elevated left atrial pressure in patients with HF with preserved ejection fraction, who remain symptomatic despite appropriate medical management, according to a company press release.

Researchers for the study will enroll patients at up to 20 sites in the United States and up to 8 sites outside of the United States, according to the release.

“Treating heart failure patients, especially those with preserved ejection fraction, continues to be a challenge as current pharmacological treatments are ineffective,” Martin Leon, MD, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center and chair of the Corvia Medical scientific advisory group, stated in the release. “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 NYHA functional class, exercise capacity and quality of life for this patient population.”

The device is deployed after creation of a small opening in the atrial septum and forms a passage between the left and right atria to enable the left atrium to decompress, with the aim of lowering left atrial pressure, according to the release. The system is not yet available for commercial distribution in the United States.