VahatiCor Completes Compassionate Use Study of A-Flux Reducer System

November 11, 2024—VahatiCor, Inc., a T45 Labs portfolio company, announced the completion of a compassionate use study treating patients with the A-Flux reducer system for either obstructive coronary artery disease with persistent symptoms or symptomatic coronary microvascular dysfunction (CMD).

According to VahatiCor, the compassionate use study was composed of 10 patients who were implanted with A-Flux device: four with CMD and six with obstructive epicardial disease. The study aims to demonstrate the safety and early efficacy of the A-Flux device as a promising therapeutic option for patients with these conditions.

The company advised that based on the positive results from the compassionate use study, it plans to commence SERRA-I, its United States early feasibility study, which will be exclusively focused on patients with CMD.

The trial will be led by Coprincipal Investigators Samit Shah, MD, and Tim Van de Hoef, MD. Dr. Shah is an interventional cardiologist with Yale School of Medicine in New Haven, Connecticut, and Dr. Van de Hoef is an interventional cardiologist with University Medical Center Utrecht, in Utrecht, the Netherlands.

VahatiCor stated that the A-Flux reducer system offers a novel, minimally invasive approach to directly improve flow within the coronary microvasculature and relieve anginal symptoms in patients with CMD.

The company further noted that the short implantation procedure time (average, 9 minutes) and clinical outcomes of the A-Flux reducer system highlight its potential to become a frontline device therapy for patients with persistently symptomatic CMD.

Additionally, VahatiCor’s A-Flux is engineered with its SwiftCell technology, a small-cell design based on computational modeling, to redistribute oxygen supply to the subendocardium layer of the heart muscle, noted the press release.

“Patients with CMD, which is more common in women, experience significant symptoms that can happen at rest and during exertion,” commented Dr. Shah in VahatiCor’s press release. “There is a real need for an effective treatment for these patients. The A-Flux reducer system has innovative properties, including its atraumatic expansion and repositionable design. I look forward to supporting the development of clinical evidence for this novel therapy.”

Dr. Van de Hoef added, “About half of the patients undergoing an invasive angiography are found not to have obstructive coronary artery disease but, in fact, have CMD. Increasingly, more patients are likely to be identified as centers begin adopting the strong guidelines recently published by the European Society of Cardiology. These patients have no dedicated treatment available. Coronary sinus reduction and the advanced features of the A-Flux device carry significant potential to help these patients return to normal daily activities.”