AtaCor Medical’s ASCEND EV Clinical Study Begins

AtaCor Medical Inc. has initiated an international, non-randomized study to assess the safety and performance of its all-in-one Extravascular Implantable Cardioverter Defibrillator (EV-ICD) Lead System against other commercially available transvenous ICDs.

Initial ASCEND EV trial cases were performed at a single clinical site and demonstrated successful sensing and defibrillation of induced ventricular fibrillation using the Atala lead in connection to a range of commercially available ICDs.

“Extravascular solutions allow physicians to deliver critical therapy while maintaining the integrity of the heart,” commented Dr. Shephal Doshi, ASCEND EV study investigator and executive director of the Heart and Vascular Institute, Providence Saint John’s Health Center & Cardiac Electrophysiology at the Pacific Heart Institute/Cedars Sinai. “AtaCor’s innovative design is an exciting advancement with the potential to elevate the standard for cardiac rhythm management. I am impressed by these first cases, and I look forward to following the clinical progress as more patients are treated.”

The AtaCor EV-ICD Lead System aims to deliver life-saving ICD benefits without the complications associated with transvenous leads or the pacing discomfort associated with other extravascular ICD systems. The all-in-one system facilitates both antitachycardia pacing (ATP) and shock delivery from a single lead and with one procedure—all without entering the heart or vascular system. Implanted via a streamlined parasternal approach, the system is designed for compatibility with commercially available transvenous ICDs and will accommodate either a lateral or left-pectoral pulse generator pocket placement.

“AtaCor is committed to revolutionizing cardiac rhythm management and protecting the integrity of the heart for future cardiac care needs. We are thrilled to have successfully completed this first round of cases, a critical step towards validating AtaCor’s Atala lead,” AtaCor Medical Chief Medical Officer Dr. Martin Burke stated. “Thank you to the entire AtaCor team for their efforts and our physician partners for their invaluable expertise to achieve this milestone. We look forward to adding additional clinical sites in the coming months.”

The AtaCor EV-ICD Lead System is under development for investigational use and is not approved for sale in any geography.

AtaCor is striving to transform cardiac rhythm management with novel extravascular leads and deployment systems designed to eliminate the risks, costs, and drawbacks associated with traditional transvenous leads.