First US patient enrolled in device study to reduce coronary microvascular dysfunction

June 20, 2026 - 03:57

A new clinical study has begun in the United States, testing a device designed to treat coronary microvascular dysfunction, a condition that affects the heart's smallest blood vessels. The first patient has been enrolled in the trial, which evaluates the A-Flux device, a self-expanding implant placed in the coronary sinus. By increasing pressure on the venous side of the heart, the device aims to improve blood flow and perfusion in the tiny vessels that are often damaged or dysfunctional.

Coronary microvascular dysfunction is a challenging condition, particularly common in women, where standard angiograms may appear normal despite significant symptoms like chest pain and shortness of breath. The A-Flux device offers a novel approach by altering hemodynamics to push more blood through these small arteries. The procedure is minimally invasive, with the implant delivered via catheter.

Researchers hope this therapy could provide relief for patients who have limited treatment options. The study will track safety and effectiveness over time, measuring improvements in symptoms and heart function. If successful, the device could fill a major gap in cardiovascular care, addressing a root cause of ischemia that has been difficult to target with medications or stents alone.