Revamp Medical, a pioneering developer of a percutaneous device for the treatment of acute heart failure (AHF), today announced the enrollment of the first patient in a multi-site Early Feasibility Study (EFS), the DORAYA-HF. The proprietary catheter has been designed to enable cardiologists to improve venous hemodynamics (cardiac preload and renal afterload), aiming at improving diuretic efficacy.
The Early Feasibility Study is being conducted by cardiologists at several US heart failure programs, including The Christ Hospital, an acute care hospital in Cincinnati, Ohio, and one of the world’s best specialized hospitals for Cardiology. The cardiologists at The Christ Hospital are first in the US to enroll a patient to the EFS. The EFS will primarily examine the safety and performance of Doraya.
The Doraya catheter 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 heart failure 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 Early Feasibility Study,” said Dr. Eugene S. Chung, MD, an Advanced Heart Failure cardiologist at The Christ Hospital in Cincinnati, OH. “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.”
“This is an important milestone for us and for AHF patients worldwide, reflecting our efforts to improve AHF patients’ response to diuretic therapy, thereby rapidly alleviate signs and symptoms of congestion,” said Yael Shohat, COO of Revamp Medical. “We believe Doraya has the potential to fill this large unmet need.”