AtaCor Medical Begins Study of its Parasternal Extravascular Implantable Cardioverter-Defibrillator System

AtaCor Medical Inc. is enrolling patients in its ALARION-EV study, which will evaluate an investigational next-generation parasternal extravascular implantable cardioverter-defibrillator (EV-ICD) system.

The solution combines AtaCor’s Atala lead with an EV-ICD pulse generator developed by Abbott for patients who need 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,” commented Devi G. Nair, M.D., chief of Cardiac Electrophysiology and Research at St. Bernards Medical Center in Jonesboro, Ark., the first global site to enroll a trial patient. “AtaCor’s investigational extravascular ICD solution uses a 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.”

The ALARION-EV trial is a prospective, multi-center, single-arm study that will enroll up to 280 patients in up to 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 U.S. Food and Drug Administration 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 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 might offer a new option for EV-ICD systems. This unique investigational approach is designed to deliver defibrillation and antitachycardia pacing, obviating longstanding 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,” AtaCor CEO Rick Sanghera stated. “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, and is limited exclusively for investigational use. It is not approved for sale.

AtaCor Medical is attempting to transform the cardiac rhythm management industry with its proprietary Atala lead. Its design provides the therapeutic capabilities of traditional implantable defibrillators, including defibrillation and antitachycardia pacing, without placing hardware inside the heart or vascular system. AtaCor’s technology preserves future cardiac treatment options and overcomes key limitations of existing ICD systems. AtaCor’s venture investors include Arboretum Ventures, Broadview Ventures, Longview Ventures, Hatteras Venture Partners, Catalyst Health Ventures, and BayMed Venture Partners.