Revamp Medical this week said its Doraya acute heart failure catheter received FDA breakthrough device designation.
Doraya is a temporary intravenous catheter that is placed in the inferior vena cava below the renal veins. It applies partial adjustable flow for up to 12 hours.
The device features a flow regulator mechanism that is designed to temporarily reduce central venous pressure and improve the diuretic response in patients with acute heart failure and insufficient response to diuretic therapy.
Revamp Medical is currently evaluating the device and a first in human clinical study in Europe.
“Worsening Renal Function is a major challenge in the treatment of acute heart failure. We hope to provide cardiologists with a valuable tool to improve care of insufficient diuretic responder patients, in hopes of resetting the ‘cardiorenal clock,'”CEO Liu Avitov said in a news release. “As we begin to accelerate our clinical development program in the US, we plan to leverage the benefits of FDA Breakthrough Device Designation.”
