AtaCor Medical Enrolls First Patient in ALARION-EV Pivotal Trial

July 7, 2026 —AtaCor Medical has announced the enrollment of the first patient in the company's ALARION-EV trial (NCT07324031). The trial evaluates an investigational next-generation parasternal extravascular implantable cardioverter-defibrillator (EV-ICD) system featuring AtaCor's Atala lead in combination with an EV-ICD pulse generator developed by Abbott in patients who are indicated for a standard ICD but do not require chronic pacing therapy for slow heart rhythms.

"Arrhythmia Research Group is excited to participate in the ALARION-EV study, and we are pleased to contribute to the evaluation of this technology," said Devi G. Nair, MD, FACC, FHRS, Chief of Cardiac Electrophysiology and Research at St. Bernards Medical Center in Jonesboro, Arkansas. "AtaCor's investigational extravascular ICD solution uses a novel parasternal lead delivery and is designed to allow physicians to deliver necessary antitachycardia pacing and shock therapies while avoiding the vascular and cardiac complications associated with traditional transvenous ICD systems."

Multi-Center, Single-Arm Trial

The ALARION-EV trial is a prospective, multi-center, single-arm study that will enroll up to 280 patients across as many as 40 sites in the United States and the Netherlands. The AtaCor-sponsored study aims to demonstrate the safety and effectiveness of the investigational parasternal EV-ICD System through at least six months of follow-up, with collected data to support a future premarket approval (PMA) submission.

While ICDs are a cornerstone therapy for preventing sudden cardiac death in patients with ventricular arrhythmias, traditional systems require leads to be placed inside the heart, which can lead to vascular injury, lead fractures, malfunctions, and infections. The novel design of 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, outside of the heart and vasculature. Abbott's investigational EV-ICD pulse generator can be placed in either a lateral or pectoral device pocket, which could offer a new option for EV-ICD systems. This unique investigational approach is designed to deliver defibrillation and antitachycardia pacing, obviating long-standing transvenous lead management considerations and reducing the need for complex revisions associated with leads placed 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," commented 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."

The AtaCor-Abbott parasternal EV-ICD system, including the Atala lead and EV-ICD pulse generator, is under development, is limited exclusively for investigational use and is not approved for sale in any geography.