Medtronic has announced that the longer-term follow-up data from the pivotal study on the Extravascular Implantable Cardioverter Defibrillator (EV ICD) system has further confirmed its safety and effectiveness.
The EV ICD system is an implantable defibrillator that helps avoid the risks associated with traditional transvenous ICDs by placing its lead outside the heart and veins, beneath the sternum (breastbone).
Implanted using a minimally invasive approach, it provides pause prevention pacing, anti-tachycardia pacing and a single device that is comparable in size, shape and battery life to traditional transvenous ICDs.
Medtronic cardiovascular portfolio’s cardiac rhythm management business chief medical officer Dr Alan Cheng said: “The expansive data on Medtronic ICDs presented at Heart Rhythm 2023 reinforce the impact these therapies have for patients at risk of life-threatening heart rhythms.
“Collectively, these findings demonstrate our unparalleled commitment to providing innovative solutions that improve patient experiences and outcomes even as medical care advances.”
The EV ICD Pivotal study evaluated the safety and effectiveness of the EV ICD system in patients who are vulnerable to sudden cardiac death.
The multicentre, prospective, non-randomised, single-arm and pre-market clinical study recruited 356 patients at 46 sites across 17 countries in Europe, North America, Australia, New Zealand, Asia and the Middle East.
According to the study, approximately 6.8% of the 299 patients who received implants experienced appropriate therapy within 18 months.
There were 19 individuals who encountered a total of 80 spontaneous arrhythmic episodes that were treated appropriately.
The freedom rate from major complications associated with EV ICD systems or procedures at 18 months was 91.9%.
The company received a CE mark for the Aurora EV ICD system, as well as approval from the US Food and Drug Administration to carry out a continued access study related to the system.