AtaCor Medical has enrolled the first patient in its ALARION-EV pivotal trial, which is evaluating an investigational extravascular implantable cardioverter-defibrillator (EV-ICD) system.
The study is designed for patients who need a standard ICD but do not require chronic pacing for slow heart rhythms.
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The EV-ICD uses AtaCor’s Atala lead and a pulse generator developed by Abbott. The initial enrolment took place at the St Bernards Medical Center in Jonesboro, Arkansas, US.
The prospective, multi-centre, single-arm trial will enrol around 280 patients at up to 40 locations in the US and the Netherlands.
The AtaCor-sponsored study aims to gather data on the safety and effectiveness of the investigational parasternal EV-ICD system through at least six months of follow-up.
Results from the trial are expected to support a future premarket approval submission.
The Atala lead is designed to be implanted through a small left parasternal incision, with electrodes placed outside the heart and vasculature against the pericardium. Abbott’s pulse generator is intended to be positioned in either a lateral or pectoral device pocket.
AtaCor Medical CEO Rick Sanghera said: “This clinical milestone is a significant step forward in AtaCor’s mission to transform cardiac rhythm management. The successful treatment of our first patient in the ALARION-EV trial reflects the strength of our innovation, as well as the dedication of our teams and clinical partners.
“We look forward to building on this initial momentum and remain committed to advancing these extravascular therapies to improve patient outcomes and drive meaningful evolution in cardiac care.”
The AtaCor-Abbott EV-ICD system remains investigational, with no regulatory approval or commercial availability at this time.
In April 2024, AtaCor closed a Series C financing round, raising $28m for delivering a next-generation EV-ICD and pacing options for cardiac rhythm management.
