VahatiCor Launches U.S. Clinical Trials for CMD Heart Implant
At Yale-New Haven Hospital, clinicians have enrolled the first American patient in the SERRA-I study, marking the entry of VahatiCor’s A-FLUX Reducer System into the U.S. market for investigation. The trial targets coronary microvascular dysfunction, a condition causing persistent chest pain that remains largely unaddressed by current cardiac therapies.
The SERRA-I early feasibility study evaluates the A-FLUX Reducer System, a self-expanding nitinol implant delivered via catheter to the coronary sinus. By modifying blood flow through the heart's smaller vessels, the device aims to mitigate the symptoms of coronary microvascular dysfunction (CMD) in patients who show no blockages in their larger coronary arteries.
Samit Shah, MD, PhD, an interventional cardiologist at Yale New Haven Hospital and co-principal investigator for the study, noted that patients with CMD are currently underserved, as no U.S.-approved treatment directly targets the microvascular source of their disease. VahatiCor CEO Harry D. Rowland stated that the milestone reflects a broader shift in cardiology toward treating microvascular disease as a primary, frontline condition. While the device remains investigational and lacks U.S. FDA commercial approval, the company intends for the SERRA-I program to provide the clinical evidence necessary to bridge this treatment gap for millions of symptomatic patients.
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