AtaCor Medical has enrolled the first patient in the ALARION-EV pivotal trial evaluating its next-generation extravascular implantable cardioverter-defibrillator (EV-ICD) system, developed in partnership with Abbott.
The investigational system combines AtaCor’s Atala parasternal lead with Abbott’s EV-ICD pulse generator and is intended for patients who require an implantable cardioverter-defibrillator but do not need chronic pacing for slow heart rhythms. The study plans to enroll up to 280 patients across as many as 40 sites in the U.S. and the Netherlands, with data intended to support a future FDA premarket approval (PMA) submission.
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AtaCor’s technology is designed to deliver cardiac rhythm management without placing leads inside the heart or blood vessels, potentially reducing the long-term risks associated with conventional ICD systems.
CEO Rick Sanghera said:
“The successful treatment of our first patient in the ALARION-EV trial reflects the strength of our innovation, as well as the dedication of our teams and clinical partners.”
The first patient enrollment marks a key milestone in the clinical development of AtaCor’s extravascular defibrillation platform and advances its collaboration with Abbott to bring next-generation ICD technology to market.
