AtaCor Medical, Inc., a medical device company based in San Clemente, California, has raised up to $75 million in financing to support a U.S. FDA pivotal study of its extravascular implantable cardioverter-defibrillator system, designed to treat ventricular tachyarrhythmias.
“There is a clear and growing need for extravascular ICD systems that combine a straightforward implant procedure with the ability to deliver the full spectrum of tachyarrhythmia therapies using a small pulse generator. AtaCor is poised to meet that need. We are proud to close this financing round and excited to initiate our pivotal trial next year,” AtaCor Medical’s Rick Sanghera said in a statement.
The EV-ICD system includes the Atala lead and a small device that’s implanted under the skin. The lead is placed outside the heart through a small cut near the chest, with electrodes positioned near the heart’s outer lining. According to the company, this setup avoids putting wires inside the heart or veins, potentially lowering long-term risks.
AtaCor has completed enrollment of its pilot study and plans to present early findings at the Asia Pacific Heart Rhythm Society meeting in November in Yokohama, Japan. Based on the results, the company plans to begin a larger study in the United States and Europe to evaluate the safety and effectiveness of the system and support future regulatory submissions.
