Image Credit: Atacor
AtaCor Medical, Inc., a privately-held medical device company, announced the enrollment of the first patient in the ALARION-EV study to evaluate its Atala™ parasternal extravascular lead with an Abbott implantable cardioverter-defibrillator (EV-ICD).
The Atala™ lead is implanted through a small left parasternal incision, with the lead positioned through a rib space and electrodes placed against the pericardium. The lead allows the IPG to be placed in either a lateral or pectoral device pocket.
The ALARION-EV trial is a prospective, multi-center, single-arm study that will enroll up to 280 patients in up to 40 sites in the US and the Netherlands, aiming to demonstrate the safety and effectiveness of the Abbott investigational parasternal EV-ICD System through at least six months of follow-up to support a PMA.