The companies aim to advance a next-generation investigational extravascular implantable cardioverter defibrillator (EV-ICD) system.
AtaCor, a cardiac rhythm management (CRM) company, develops extravascular defibrillation technologies. Its offerings aim to reduce the risks associated with traditional ICDs. The company raised $75 million last fall to support the U.S. pivotal study of its defibrillator technology.
San Clemente, California-based AtaCor designed its EV cardiac pacing and defibrillation lead systems to provide critical CRM therapy. They offer benefits without requiring the placement of any hardware inside the patient’s heart. This eliminates some long-term risks associated with intravascular or intracardiac leads.
Through the collaboration, Abbott intends to pair AtaCor’s investigational Atala parasternal EV-ICD lead with its own investigational ICD system.
An Abbott and AtaCor integrated EV-ICD would use a minimally invasive approach, combining the benefits of traditional ICDs with design improvements. It aims to avoid complications like vascular injury, lead fractures or malfunctions and lead infections.
By keeping lead components outside the heart and vasculature, they believe the approach addresses longstanding lead management considerations. Abbott and AtaCor hope to reduce the need for complex revisions associated with leads placed through veins and across cardiac structures.
Under the collaboration, AtaCor plans to initiate a pivotal FDA investigational device exemption (IDE) study (ALARION EV) this year. The collaboration, if successful, could bring competition to Medtronic and its Aurora EV-ICD system.
“Abbott is committed to advancing transformative therapies in cardiac rhythm management. From Abbott’s revolutionary Aveir leadless pacemaker to advances in conduction system pacing (CSP) technologies, and now the potential of the next-generation EV-ICD, Abbott is redefining what’s possible to improve patient care worldwide,” said Randel Woodgrift, SVP of Abbott’s CRM business.
