ALARION-EV evaluates a next-generation parasternal EV-ICD system. It features AtaCor’s Atala lead in combination with an EV-ICD pulse generator developed by Abbott. The study evaluates the system in patients indicated for a standard ICD but do not require chronic pacing therapy for slow heart rhythms.
The first treatment took place at St. Bernards Medical Center in Jonesboro, Arkansas. San Clemente, California-based AtaCor plans to enroll up to 280 patients across as many as 40 sites in the U.S. and the Netherlands.
ALARION-EV aims to demonstrate the safety and effectiveness of the investigational parasternal EV-ICD System through at least six months of follow-up. The company intends to use collected data to support a future FDA premarket approval (PMA) submission.
AtaCor’s technology aims to reduce the risks associated with traditional ICDs. The company raised $75 million last fall to support the U.S. pivotal study of its defibrillator technology. Abbott announced a partnership to advance defibrillation therapies at the start of 2026.
The company designed its Atala EV cardiac pacing and defibrillation lead systems to provide critical cardiac rhythm management therapy. They offer benefits without requiring the placement of any hardware inside the patient’s heart. This eliminates some long-term risks associated with intravascular or intracardiac leads.
Atala allows for implantation through a small left parasternal incision, with the lead positioned through a rib space and electrodes placed against the pericardium, outside the heart and vasculature. Abbott’s investigational EV-ICD pulse generator can go in either a lateral or pectoral device pocket.
Rick Sanghera, AtaCor CEO, said:
“This clinical milestone is a significant step forward in AtaCor’s mission to transform cardiac rhythm management. 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. We look forward to building on this initial momentum and remain committed to advancing these extravascular therapies to improve patient outcomes and drive meaningful evolution in cardiac care.”
