Early Feasibility Study Begins for Revamp Medical’s Doraya Catheter for Relieving Congestion in Acute HF Patients

October 18, 2022—Revamp Medical, the Israel-based developer of the Doraya catheter for the treatment of acute heart failure (HF), announced the enrollment of the first patient in the DORAYA-HF early feasibility study (EFS) of the device.

The multicenter DORAYA-HF EFS is being conducted at several United States HF programs, including The Christ Hospital in Cincinnati, Ohio. Cardiologists at The Christ Hospital are the first investigators to enroll a patient in the EFS. The EFS will primarily examine the safety and performance of Doraya, which is under clinical investigation and is not approved for sale, advised the company.

According to Revamp Medical, the percutaneous Doraya catheter has been designed to enable cardiologists to improve venous hemodynamics, aiming at improving diuretic efficacy. The device is placed in the inferior vena cava below the renal veins, applying partial adjustable flow for up to 12 hours. The device flow regulator mechanism is designed to temporarily reduce central venous pressure and improve diuretic response in hospitalized patients with acute HF with insufficient response to diuretic therapy.

“We are very pleased and excited to be the first site to enroll a first patient in the Doraya EFS,” commented Eugene S. Chung, MD, in the company’s press release. “We believe that the Doraya catheter may represent a promising, effective treatment option for patients with acute heart failure and diuretic resistance. The elegance of this approach is that it addresses the local mechanism for diuretic resistance rather than apply the brute force of systemic drugs or dialysis.”