15 November 2017 - - US-based medical device company Corvia Medical, Inc. has enrolled the first patient in its global multicenter trial (REDUCE LAP-HF II) of the Interatrial Shunt Device (IASD) for the treatment of heart failure, the company said.
Dr. Rami Kahwash, cardiologist at the Ohio State University Wexner Medical Center, has enrolled the first patient in the REDUCE LAP-HF II trial, a prospective, multicenter, double blind randomised controlled trial to evaluate the IASD System to reduce elevated left atrial pressure in patients with heart failure with preserved or mid-range ejection fraction.
The study will enroll patients at up to 70 sites in the US and up to 30 sites outside the US.
The IASD is approved in the European Union to treat heart failure with preserved or mid-range ejection fraction (HFpEF/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 is designed to reduce heart failure symptoms.
Ameliorating the symptoms of heart failure can lead to improved quality of life, decreased heart failure hospitalization rates, and a reduction in the overall cost burden of managing heart failure patients.
Privately held Corvia Medical is dedicated to developing first-in-class transcatheter structural heart devices for the treatment of heart failure.