AtaCor Enrolls 1st Patient in EV-ICD Study in Partnership with Abbott

AtaCor Medical announced enrollment of the first patient in its ALARION-EV study.

The trial is evaluating an investigational next-gen parasternal extravascular implantable cardioverter-defibrillator (EV-ICD) featuring AtaCor’s lead with an EV-ICD pulse generator developed by Abbott in patients indicated for a standard ICD but don’t require chronic pacing therapy for slow heart rhythms.

The prospective, multi-center, single-arm study will enroll up to 280 patients at as many as 40 sites in the U.S. and the Netherlands. The study hopes to show the safety and effectiveness of the investigational, parasternal EV-ICD system through at least six months of follow-up, with data to support a future premarket approval submission.

AtaCor’s investigational Atala lead allows implantation through a small left parasternal incision, with the lead positioned through a rib space and electrodes placed against the pericardium. Abbott’s investigational EV-ICD pulse generator can be placed in either a lateral or pectoral device pocket.

The unique approach was designed to deliver defibrillation and anti-tachycardia pacing, removing long-standing transvenous lead management considerations and reducing the need for complex revisions related to lead placement through veins and across cardiac structures.

“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,” said Rick Sanghera, AtaCor’s CEO. “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.”