FDAnews
www.fdanews.com/articles/175620-corvia-wins-ide-approval-for-reduce-lap-hf-i-clinical-study

Corvia Wins IDE Approval for REDUCE LAP-HF I Clinical Study

March 7, 2016

Corvia Medical has scored IDE approval from the FDA for a study of its InterAtrial Shunt Device for the treatment of heart failure.

The REDUCE LAP-HF I study will assess the device’s ability to reduce elevated left atrial pressure in certain heart failure patients, according to the company.

"We look forward to providing physicians a technology that is designed to facilitate continuous and dynamic decompression of the left atrium and address the debilitating symptoms of heart failure," said George Fazio, president and CEO of Corvia Medical.

Additionally, the company has entered into an exclusive option-to-purchase agreement with an undisclosed strategic partner, the release states. — Anisa Jibrell