AtaCor Medical Completes Enrollment in EV-ICD Study

The 12th and final patient has been enrolled in AtaCor Medical Inc.’s small study of its acute extravascular implantable cardioverter defibrillator (EV-ICD).

The PASS-PULL EV-ICD Study is evaluating the performance of AtaCor’s EV-ICD lead compared to commercially available ICDs. “While AtaCor continues to develop novel solutions for extravascular pacing, we are excited to complete our first defibrillation study. Our goal is to revolutionize the entire cardiac rhythm management industry, and this study highlights that effort,” said Rick Sanghera, AtaCor Medical’s CEO.

When patients require ICD therapy, wires or other hardware are inserted into the veins and attached to the inside of the heart. Once implanted, this hardware can lead to serious complications and challenging removal procedures. By positioning leads outside of the heart and venous structure, AtaCor’s technology reduces dependency on transvenous ICD leads and the acute and long-term complications associated with them. AtaCor’s EV-ICD lead is designed to provide both shock and anti-tachycardia pacing therapies to treat life-threatening tachyarrhythmias, as well as pacing therapies to treat bradycardia. Using AtaCor’s custom delivery tool, the lead is designed to be inserted via a rib space at the left sternal margin above the heart, with the final lead position adjacent to the sternum, leaving the heart completely untouched.

“Extravascular lead developments are an important step forward for patient care, and AtaCor’s EV-ICD lead is designed to simplify EV-ICD lead insertion while providing defibrillation shock and pacing therapies using ICDs already available on the market,” said  Martin Burke, AtaCor’s chief medical officer. 
 
The PASS-PULL EV-ICD Study is evaluating the delivery of AtaCor’s EV-ICD lead, as well as its acute defibrillation success when connected to commercially-available ICD systems. Twelve patients were enrolled and underwent study testing.  
 
Established in 2014, AtaCor Medical’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, the extracardiac temporary pacing lead is designed to eliminate bedrest restrictions associated with temporary pacing, in order to help improve patient mobility and post-procedural recovery. AtaCor’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’s management team has over 80 years of combined experience to the company and its products. Current investors include Broadview Ventures, Hatteras Venture Partners, and Catalyst Health Ventures.

AtaCor’s extracardiac pacing and EV-ICD lead systems are under development, and not yet approved for sale.