AtaCor Medical Announces First Patient Treated Globally in its ALARION-EV Pivotal Trial
AtaCor Medical, Inc. has announced the enrollment of the first patient in its ALARION-EV study (NCT07324031), which evaluates an investigational next-generation parasternal extravascular implantable cardioverter-defibrillator (EV-ICD) system. This system features AtaCor's Atala™ lead in combination with an EV-ICD pulse generator developed by Abbott, targeted at patients who require a standard ICD but do not need chronic pacing therapy for slow heart rhythms.
Devi G. Nair, MD, FACC, FHRS, Chief of Cardiac Electrophysiology and Research at St. Bernards Medical Center in Jonesboro, Arkansas, commented on the study, stating, "Arrhythmia Research Group is excited to participate in the ALARION-EV study, and we are pleased to contribute to the evaluation of this technology." He noted that AtaCor's investigational extravascular ICD solution uses a novel delivery method designed to provide necessary antitachycardia pacing and shock therapies while minimizing complications associated with traditional transvenous ICD systems.
The ALARION-EV trial is a prospective, multi-center, single-arm study that aims to enroll up to 280 patients across as many as 40 sites in the United States and the Netherlands. This AtaCor-sponsored study will assess the safety and effectiveness of the investigational parasternal EV-ICD system over at least six months of follow-up, with data collected to support a future premarket approval (PMA) submission.
Traditional ICDs, which are essential for preventing sudden cardiac death in patients with ventricular arrhythmias, require leads to be placed inside the heart. This can lead to complications such as vascular injury and infections. AtaCor's Atala™ lead can be implanted through a small left parasternal incision, allowing for electrode positioning against the pericardium, outside the heart and vascular system. Abbott's EV-ICD pulse generator can be placed in a lateral or pectoral device pocket, offering a new option for extravascular systems.
Rick Sanghera, CEO of AtaCor, stated, "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." He expressed optimism about advancing extravascular therapies to improve patient outcomes in cardiac care.
The AtaCor-Abbott parasternal EV-ICD system, including the Atala™ lead and EV-ICD pulse generator, is currently under development and is limited to investigational use, with no approvals for sale in any geography.