SAN CLEMENTE, Calif.--(BUSINESS WIRE)--AtaCor Medical, Inc. has announced completion of its second human clinical study of the Extravascular Implantable Cardioverter Defibrillator (EV-ICD) Lead System. Building on acute data from the PASS PULL EV-ICD Study (n=18) completed in Q1-2022, the Sensing and Defibrillation with a Commercially Available ICD coupled with a Parasternal Extravascular Lead (SECURE EV) study (n=18) followed subjects with an AtaCor Medical EV-ICD lead connected to a commercially available ICD pulse generator for up to 3 months. Data from all 36 clinical study patients will be presented as a Late-Breaking Clinical Trial at the Asia Pacific Heart Rhythm Society (APHRS) Scientific Session 2022 in Singapore on November 20, 2022.
AtaCor Medical’s novel EV-ICD lead is being designed to provide both shock and pacing therapies to treat life-threatening tachyarrhythmias when connected to commercially available ICD pulse generators. The lead is designed to be inserted at the left sternal margin through a rib space above the heart, leaving the heart completely untouched.
Building upon the acute data previously collected in the PASS PULL EV-ICD study, the SECURE EV study evaluated chronic sensing and defibrillation with AtaCor’s EV-ICD lead while connected to a commercially available ICD pulse generator. All SECURE EV subjects received a concomitant transvenous ICD to allow direct comparison of sensing and detection between the traditional transvenous ICD System and an AtaCor Medical EV-ICD System.
“We are excited to build upon our acute data with completion of 3 month follow-up visits in our first chronic defibrillation study,” remarked Rick Sanghera, AtaCor Medical’s CEO. “Our goal is to revolutionize the entire cardiac rhythm management industry, and this study is a significant advancement on that road.”
Johan Aasbo, D.O., an investigator in the study, added, “The goal of AtaCor Medical’s EV-ICD lead and delivery system is to offer a novel, minimally invasive, and time efficient lead implantation modality built to connect to commercially available transvenous ICD pulse generators. It was my privilege to participate in the implantation, gathering, and analysis of the system's initial 90-day performance evaluation. This research will serve as the foundation for longer implant duration studies. The ultimate goal will be to evaluate the AtaCor Medical EV-ICD System as a viable option for sudden cardiac death risk mitigation.”
About AtaCor Medical, Inc.
Established in 2014, AtaCor Medical is transforming cardiac pacing and defibrillation. AtaCor Medical’s extracardiac pacing lead is designed to be inserted between the ribs and pericardium without the need for medical imaging, allowing for faster, less-invasive therapy delivery. AtaCor Medical’s EV-ICD lead is inserted in a similar location and is being designed to offer permanent defibrillation and pacing therapies for the treatment of life-threatening tachyarrhythmias and bradycardia.
AtaCor Medical’s management team is comprised of seasoned experts from within the implantable cardiac device and electrophysiology fields, bringing over 80 years of combined experience to the company and its products. Current investors include Broadview Ventures, Hatteras Venture Partners, and Catalyst Health Ventures. At this time, AtaCor Medical’s extracardiac pacing and EV-ICD lead systems are under development, and not yet approved for sale in any geography.
For more information, please visit www.atacor.com.