Revamp Medical’s Doraya catheter is designed to improve the efficacy of diuretic therapy in patients with acute heart failure (AHF).
Heart failure is a chronic, progressive disease complex clinical syndrome that results from any functional or structural heart disorder. Approximately 5.1 million people in the United States have clinically manifest heart failure with more than 650,000 new cases of heart failure cases getting diagnosed annually.
Doraya Catheter could shift the stats of Heart failure over the past decade.
Revamp Medical’s Doraya catheter, a manageable flow-reducing Central Venus Catheter, is deployed in the infrarenal IVC for up to 12 hours, helping cardiologists to temporarily manage venous hemodynamics, central venous pressure, renal afterload, and venous returns. Initial data from the Doraya feasibility study were presented at PCR 2019 by Dr. Reit Dierckx (OLV, Aalst, Belgium), demonstrating promising results.
Why this breakthrough designation by FDA could provide a whole new dimension in the market ?
Mellalta Meets predicts from the accumulated data and market insights where the AHF market is supposed to reach USD $336 by 2026, that even though the recovery rate has improved from past decade, in the stage D where the Patients have refractory heart failure, they require modified interventions, as only 20% of patients have a survival rate.
This breakthrough designation by FDA could be a game changing factor for Revamp Medical’s Doraya Acute Heart Failure (AHF) device, if approved.
As Lihu Avitov, Revamp Medical CEO said,
“As we begin to accelerate the clinical development program in the US, we are planning to leverage the benefits of FDA Breakthrough Device Designation.”