Abbott is teaming up with AtaCor Medical to develop a next-generation implantable cardioverter defibrillator (ICD) designed to treat dangerous cardiac arrhythmias without routing wires through the heart or veins.
The collaboration pairs Abbott’s investigational extravascular ICD system with AtaCor’s investigational parasternal extravascular ICD (EV-ICD) lead, called Atala.
AtaCor announced in October it raised $75 million it would use to fund a clinical trial of its implantable defibrillator technology.
As part of the collaboration, the San Clemente, California-based medtech plans to begin a pivotal investigational device exemption study this year to evaluate the AtaCor-Abbott EV-ICD system, the companies said in a news release.
Usually recommended for patients at high risk of cardiac arrest, ICDs detect life-threatening arrhythmias and deliver shocks to the heart to restore normal rhythm. They can also act as pacemakers.
While traditional ICDs use leads that run through blood vessels and into the heart, EV-ICDs are implanted outside the heart and blood vessels. AtaCor’s Atala lead is placed into the body through a rib space adjacent to the left side of the breastbone and rests on the surface of the pericardium.
This lowers the risk of complications such as vascular injury, lead fractures or malfunctions, and infections, according to the companies.
The minimally invasive approach “may address long-standing lead management considerations and may reduce the need for complex revisions associated with leads placed through veins and across cardiac structures,” Abbott said in the release.
For Abbott, the EV-ICD technology would bolster its growing cardiac rhythm management portfolio, which includes traditional ICDs and its Aveir leadless pacemaker, which won FDA approval in 2022.
“Abbott is committed to advancing transformative therapies in cardiac rhythm management,” Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business, said in a statement.
If successful, the device would compete with Medtronic’s Aurora EV-ICD, which the company described as the first of its kind when it received FDA approval in October 2023.
