AtaCor Medical Launches Global Trial for Extravascular ICD System
AtaCor Medical has enrolled the first patient in its ALARION-EV pivotal trial, testing a new approach to cardiac rhythm management. The study evaluates the investigational Atala™ lead paired with an Abbott pulse generator, aiming to treat ventricular tachyarrhythmias without placing hardware inside the patient’s heart or blood vessels.
The ALARION-EV trial, a prospective, multi-center study, will involve up to 280 patients across 40 sites in the United States and the Netherlands. By placing the lead through a small parasternal incision and positioning electrodes against the pericardium, the system seeks to eliminate the risks of vascular injury, lead fractures, and infections common with traditional transvenous ICDs. Dr. Devi G. Nair of St. Bernards Medical Center, where the first procedure was performed, noted that this design allows for necessary antitachycardia pacing and shock therapies while avoiding the complications associated with standard cardiac leads.
AtaCor CEO Rick Sanghera described the milestone as a key step in evolving cardiac care. The company plans to use the six-month follow-up data from this trial to support a future premarket approval submission. As the system remains strictly investigational, it is not currently available for commercial sale. The technology offers a potential alternative for patients requiring ICD therapy who do not need chronic pacing, potentially reducing the frequency of complex surgical revisions required by traditional devices.
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