VahatiCor has announced the enrolment of the first US patient in its SERRA-I early feasibility study of the A-FLUX reducer system for the treatment of coronary microvascular dysfunction.
The milestone builds on early human experience from SERRA-I and ongoing enrolment in the SERRA-I European study, the company says in a press release.
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 programmes, with centers across the USA and Europe. The first US patient was enrolled at Yale-New Haven Hospital (New Haven, USA), with Samit Shah serving as co-principal investigator of SERRA-I.
“Treating our first US patient brings the A-FLUX reducer system into US clinical investigation,” said Harry D Rowland, 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.”
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 USA that directly targets microvascular disease,” said Shah. “Enrolling our first U.S. patient is an important step in generating the evidence these patients need.”
