AtriCure (Nasdaq:ATRC) announced today that it treated the first patient in its HEAL-IST clinical trial in Belgium.
Dr. Mark LaMeir and Dr. Carlo de Asmundis treated the first patient in the HEAL-IST trial evaluating the AtriCure Isolator Synergy claimp for treating drug-refractory patients diagnosed with inappropriate sinus tachycardia (IST) at University Hospital Brussels.
“Symptomatic IST is a serious arrhythmia that dramatically decreases the quality of life in predominantly younger adults, and more specifically, young women,” Dr. LaMeir, Head of Cardiac Surgery at University Hospital Brussels and co-principal investigator in the HEAL-IST trial, said in a news release. “Further, since current antiarrhythmic drug treatment has limited long-term effect, and societal guidelines do not advise sinus node ablation or modulation, this landmark study of sinus node sparing hybrid ablation has the potential to establish a standard of care for these patients.”
Mason, Ohio-based AtriCure’s Isolator Synergy clamp is the first and only surgical ablation device offered with FDA approval for the treatment of AFib and the only device — either catheter or surgical — to be approved for the treatment of persistent and long-standing persistent AFib, according to the company.
The HEAL-IST trial of 142 patients at up to 40 centers in the U.S. and Europe is evaluating a therapy involving a hybrid epicardial and endocardial procedure in which a cardiac surgeon and an electrophysiologist work together to create lesions on the right side of the heart. It has a primary effectiveness endpoint of freedom from IST, with a primary safety endpoint of procedure- or device-related adverse events through 30 days after the surgery is completed.
“We believe that cardiac surgeons and electrophysiologists working together is a safe and highly effective way to treat complex arrhythmias,” AtriCure President and CEO Michael Carrel said. “The HEAL-IST trial is an example of AtriCure’s commitment to, and leadership in improving the lives of patients. The therapy has the potential to significantly expand our addressable markets.”