Abbott today announced a collaboration with AtaCor Medical to advance a next-generation investigational extravascular implantable cardioverter defibrillator (EV-ICD) system designed to deliver defibrillation therapy to people with life-threatening heart rhythms.
AtaCor is a cardiac rhythm management (CRM) company developing extravascular defibrillation technologies designed to reduce risks associated with traditional ICDs. Through the collaboration, AtaCor's investigational parasternal EV-ICD lead (Atala) will be paired with Abbott's investigational ICD system.
A traditional ICD lead is connected to the heart and monitors its rhythm to help detect dangerous irregularities. The Abbott-AtaCor Investigational EV-ICD system is a minimally invasive approach that combines the benefits of traditional ICDs with design improvements, avoiding complications like vascular injury, lead fractures or malfunctions and lead infections. By keeping lead components outside the heart and the vasculature, the approach expects to address long-standing lead management considerations and may reduce the need for complex revisions associated with leads placed through veins and across cardiac structures.
As part of the collaboration, AtaCor plans to initiate a pivotal Investigational Device Exemption (IDE) clinical trial, the ALARION EV Study, in 2026 to evaluate the AtaCor and Abbott investigational parasternal EV-ICD system. AtaCor's Atala lead remains outside of the blood vessels and is placed into the body through a rib space adjacent to the left side of the breastbone. In addition to delivering defibrillation shocks, the novel directional lead design is intended to deliver pacing energy toward the heart more efficiently than currently available products.
