Medtronic launches study of extravascular ICD system
Medtronic on Oct. 7 announced the launch of its EV ICD pivotal study—a prospective, pre-market trial designed to assess the efficacy of an extravascular system in treating dangerous arrhythmias.
According to a statement from the health tech company, Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV ICD) system was designed to deliver defibrillation and pacing therapy in the same package as a traditional, transvenous ICD—just with a lead placed outside the heart and veins. The system is the same shape and size as run-of-the-mill ICDs—33 cubic centimeters—and is expected to have similar longevity.
The EV ICD study will focus on a primary effectiveness endpoint of defibrillation testing success rate at implant and a primary safety endpoint of freedom from major system and/or procedural complications at six months. It will be a multicenter, single-arm, non-randomized study that will enroll up to 400 patients at up to 60 sites across North America, Europe, the Middle East, Asia, Australia and New Zealand.
“Along with the other study investigators, I am enthusiastic to evaluate the safety and efficacy of this new approach, and its potential to deliver lifesaving ICD therapy without the risks associated with leads inside the veins and heart and without compromising on the features available in traditional ICDs,” Bradley P. Knight, MD, of Northwestern Medicine’s Bluhm Cardiovascular Institute, said in the statement.
Indeed, the new system reportedly provides the benefits of transvenous ICDs in a single system, including defibrillation therapy, anti-tachycardia pacing, post-shock pacing and back-up bradycardia pacing.
Medtronic stressed that the EV ICD system is approved only for investigational use and isn’t available for sale or distribution anywhere in the world. Its pivotal study succeeds the first successful chronic EV ICD pilot study, which involved 21 patients in New Zealand and Australia.
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.