Irish medical device company AtriAN Medical today announced that clinical data from it’s first-in-human study was presented at this years renowned Annual AF Symposium in New York City.
AtriAN has to-date enrolled nineteen patients in the company’s Neural AF multi-center study, using a unique cardiac autonomic ablation technology for the treatment of atrial fibrillation. The Neural AF study is assessing the safety and feasibility of AtriAN’s pulsed field ablation (PFA) technology for the selective ablation of cardiac autonomic neuronal tissue. An update on the clinical data was presented by Prof Vivek Reddy MD of Mount Sinai Hospital (NY), at the session on Late Breaking Clinical Trials and First Report Investigations, on January 14th, 2022.
The treatment methodology targets specific locations on the exterior surface of the heart where atrial fibrillation initiates. By delivering very short and precise electric fields, the device eliminates hyperactive neuronal cells at these locations. This leads to a reduction in the heart’s overall sensitivity to atrial fibrillation.
The first procedures have been performed on patients undergoing concomitant coronary artery bypass grafting (CABG); at Tbilisi Heart & Vascular Clinic in Georgia and Na Homolce Hospital, in Prague, Czech Republic. “The AtriAN system is an exciting development, opening up the possibility of addressing the autonomic origin of atrial fibrillation, which has largely been ignored by existing ablation technologies,” said Prof Tamaz Shaburishvili of Tbilisi Heart & Vascular Clinic.
The AtriAN system includes catheters designed for use within the pericardial space and a generator for providing the low energy pulsed electric fields, that are delivered via the catheters, directly into the epicardial neuronal tissues.
“The field of selective cardioneuroablation offers great promise among the treatment options for atrial fibrillation and it is exciting to see the AtriAN system now being assessed clinically,” said Prof Joris de Groot, at Amsterdam UMC. “Arrhythmia recurrence is a widespread problem with current ablation technologies – the AtriAN selective autonomic ablation has the potential to resolve this issue.”
“The positive outcomes from these initial patients is a key clinical milestone for us, following on from several years of scientific research and engineering development,” said AtriAN CEO Ken Coffey. “We look forward to continuing development of the technology in order to bring it to wider cohorts of patients.”
