A-FLUX Reducer System enters U.S. clinical evaluation in the SERRA-I early feasibility study
SANTA CLARA, Calif., June 17, 2026 /PRNewswire/ -- VahatiCor, Inc., a medtech company developing interventional therapies for coronary microvascular dysfunction (CMD), today announced the enrollment of the first United States patient in its SERRA-I early feasibility study of the A-FLUX Reducer System. The milestone builds on early human experience from SERRA-I and ongoing enrollment in the SERRA-I European (EU) study.
SERRA-I is evaluating the initial use of the A-FLUX Reducer System in patients with symptomatic CMD. The study is part of the broader SERRA clinical program, with centers across the U.S. and EU. The first U.S. patient was enrolled at Yale-New Haven Hospital, with Samit Shah, MD, PhD, an interventional cardiologist with Yale New Haven Hospital Heart & Vascular Center and assistant professor of medicine at Yale School of Medicine, serving as co-principal investigator of SERRA-I.
"Treating our first U.S. patient brings the A-FLUX Reducer System into U.S. clinical investigation," said Harry D. Rowland, PhD, Chief Executive Officer of VahatiCor. "Cardiology is moving toward treating microvascular disease as a frontline condition, and the A-FLUX Reducer System is built for this shift. I'm grateful to the SERRA-I investigators and to the patients who are making this study possible."
CMD affects millions of patients who experience persistent angina (chest pain) and related symptoms without blockages in the large coronary arteries. The A-FLUX Reducer System is a self-expanding nitinol device, delivered by catheter to the coronary sinus, designed to influence blood flow through the heart's smaller vessels and address the underlying microvascular dysfunction.
"Patients with CMD are highly symptomatic and underserved by current therapies, with no approved option in the United States that directly targets microvascular disease," said Samit Shah, MD, PhD. "Enrolling our first U.S. patient is an important step in generating the evidence these patients need."
About VahatiCor
VahatiCor, Inc., a T45 Labs portfolio company, is developing interventional therapies for coronary microvascular dysfunction (CMD), a condition affecting millions of patients who experience persistent chest pain despite no obstruction in their major coronary arteries. The A-FLUX Reducer System is the company's lead technology, a self-expanding, repositionable coronary sinus reducer currently under clinical evaluation in the SERRA clinical program. The company is based in Santa Clara, California. For more information, visit vahaticor.com. The A-FLUX Reducer System is an investigational device and has not been approved by the U.S. Food and Drug Administration for commercial use.
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