VahatiCor Launches U.S. Clinical Trial for CMD Treatment Device
Yale-New Haven Hospital has enrolled the first U.S. patient in the SERRA-I feasibility study, marking a pivotal expansion for VahatiCor’s A-FLUX Reducer System. The device, a self-expanding nitinol implant, aims to address coronary microvascular dysfunction, a condition causing persistent chest pain for which no FDA-approved targeted treatment currently exists.
The SERRA-I trial evaluates the initial use of the A-FLUX Reducer System in patients suffering from symptomatic coronary microvascular dysfunction (CMD). By focusing on the heart's smaller vessels, the device seeks to restore proper blood flow in patients who experience angina despite having clear large coronary arteries. Samit Shah, MD, PhD, an interventional cardiologist at the Yale New Haven Hospital Heart & Vascular Center, serves as co-principal investigator for the study.
This U.S. milestone complements ongoing European evaluations within the broader SERRA clinical program. VahatiCor CEO Harry D. Rowland noted that the company’s technology aligns with a growing cardiology trend to treat microvascular disease as a primary condition rather than a secondary concern. As an investigational device, the A-FLUX Reducer System remains unavailable for commercial use pending further regulatory evidence.
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