The (EV ICD) study evaluated the EV ICD system in 356 patients with arrhythmias who are at risk of sudden cardiac death at 46 sites in 17 countries in North America, the EU, the Middle East, Asia, Australia & New Zealand
The results meet its safety & efficacy EPs i.e., patients achieved a defibrillation success rate of 98.7% over historical transvenous ICD studies, and all discrete spontaneous arrhythmias were treated (100%). At 6mos., 92.6% were free from the major system, no major intraprocedural complications & no complications related to the EV ICD procedure or system were observed. The results were presented at ESC 2022 & published in the NEJM
Additionally, 29 patients experienced inappropriate shocks (9.7%) with a follow-up of 10.6mos.
Ref: PRNewswire | Image: Medtronic
