AtaCor Medical has announced that it has initiated its ASCEND EV study—a prospective, non-randomised international study aiming to evaluate the safety and performance of the company’s all-in-one extravascular implantable cardioverter defibrillator (EV-ICD) lead system in combination with leading commercially available transvenous ICDs.
The initial 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, as noted in an AtaCor press release.
“Extravascular solutions allow physicians to deliver critical therapy while maintaining the integrity of the heart,” commented ASCEND EV study investigator Shephal Doshi (Pacific Heart Institute/Cedars Sinai, Los Angeles, USA). “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.”
According to the company’s recent release, 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—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 further claims.
“AtaCor is committed to revolutionising 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,” stated Martin Burke, the company’s chief medical officer. “Thank you to the entire AtaCor team for their tireless efforts and our physician partners for their invaluable expertise to achieve this important milestone. We look forward to adding additional clinical sites in the coming months.”
The AtaCor EV-ICD lead system is under development exclusively for investigational use and is not approved for sale in any geography, according to the company.
