SAN CLEMENTE, Calif.--(BUSINESS WIRE)--AtaCor Medical, Inc. (“AtaCor”) announced today that it will present initial findings from its first-in-human extravascular implantable cardioverter defibrillator (EV-ICD) study during the upcoming Stanford Biodesign New Arrhythmia Technologies Retreat. The presentation, leading up to the Heart Rhythm 2022 Scientific Congress in San Francisco, is scheduled for 9:50 a.m. on Thursday, April 28, 2022, in Palo Alto, CA.
AtaCor announced completion of the study, named the PASS-PULL EV-ICD Study, in December 2021 with an initial cohort of 12 patients. Researchers designed the PASS-PULL EV-ICD Study to evaluate the delivery of AtaCor’s EV-ICD defibrillation lead, as well as its acute defibrillation success when connected to commercially available transvenous ICD systems placed in a lateral device pocket. They subsequently expanded the study this year to include an additional group of six (6) patients with ICD pulse generators placed in a pectoral device pocket.
Currently, when patients require ICD therapy, a physician must insert wires or other hardware into the veins and attach them to the inside of the heart. Once implanted, this hardware can lead to serious complications and challenging removal procedures. More recently, a subcutaneous ICD system has been introduced; however, the system requires a larger pulse generator due to higher shock energy requirements and lacks other features such as bradycardia and antitachycardia pacing therapies.
By positioning leads outside of the heart and venous structure, AtaCor’s goal is to reduce dependency on transvenous ICD leads and the acute and long-term complications associated with them. AtaCor’s novel EV-ICD lead is being designed to provide both shock and antitachycardia pacing therapies to treat life-threatening tachyarrhythmias, as well as pacing therapies to treat bradycardia. Using AtaCor’s custom delivery tool, the physician inserts the EV-ICD lead via a rib space at the left sternal margin above the heart, with the final lead position adjacent to the sternum, leaving the heart untouched.
“We are excited to share the initial findings of the expanded PASS-PULL EV-ICD Study. An EV-ICD solution that offers physicians the option to use commercially available transvenous ICDs, placed in either a lateral or pectoral pocket, does not currently exist. We are proud to have such an option in development,” remarked Rick Sanghera, AtaCor Medical’s CEO.
Dr. Martin Burke, AtaCor’s Chief Medical Officer, who will present the initial findings, added, “Extravascular lead systems that offer the ability to deliver shock and pacing therapies will greatly expand options for patients, especially systems that simplify lead delivery, such as AtaCor’s parasternal approach.”
About AtaCor Medical, Inc.
Established in 2014, AtaCor Medical is transforming cardiac pacing and defibrillation. AtaCor’s extracardiac pacing lead is designed to be inserted between the ribs and pericardium without any need for medical imaging, allowing for faster, less-invasive therapy delivery. Furthermore, AtaCor is designing the extracardiac temporary pacing lead to eliminate bedrest restrictions associated with contemporary temporary pacing to help improve patient mobility and post-procedural recovery. Now, AtaCor is designing its EV-ICD lead to be inserted in a similar location to offer permanent defibrillation and pacing therapies for the treatment of life-threatening tachyarrhythmias and bradycardia.
AtaCor’s extracardiac pacing and EV-ICD lead systems are currently under development, and not yet approved for sale in any geography.
For more information, please visit www.atacor.com.