VahatiCor has enrolled the first U.S. patient in its SERRA-I early feasibility study, evaluating the investigational A-FLUX Reducer System® for patients with coronary microvascular dysfunction (CMD).
The study, conducted in the U.S. and Europe, is assessing the safety and initial performance of the catheter-delivered device in patients with symptomatic CMD — a condition that can cause persistent chest pain despite the absence of major coronary artery blockages.
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The A-FLUX Reducer System is a self-expanding nitinol implant designed to be placed in the coronary sinus to influence blood flow and address microvascular dysfunction.
VahatiCor CEO Harry D. Rowland said:
“Cardiology is moving toward treating microvascular disease as a frontline condition, and the A-FLUX Reducer System is built for this shift.”
Dr. Samit Shah, co-principal investigator, added:
“Patients with CMD are highly symptomatic and underserved by current therapies, with no approved option in the United States that directly targets microvascular disease.”
The milestone marks the start of U.S. clinical evaluation for a potential new treatment approach for CMD patients.
