SPAIN- Medtronic has revealed that their extravascular implanted cardioverter defibrillator (EV ICD) has satisfied safety and efficacy goals, with a defibrillation success rate of 98.7% in a global clinical trial.
The results from the EV ICD Pivotal Study were presented as late-breaking science at the European Society of Cardiology (ESC) Congress 2022 in Barcelona, Spain.
The global leader in medical technology noted that the medical device is intended to treat rapid heartbeats that can cause cardiac arrest.
The lead is positioned beneath the sternum, which, according to Medtronic, helps prevent problems like infection or vascular occlusion that can occur with leads in the heart and veins.
Ian Crozier, MB, CHB, M.D., Christchurch Hospital, Christchurch, New Zealand, presented the results at ESC Congress 2022.
“We are very encouraged by the high defibrillation effectiveness and strong safety profile of the EV ICD system seen in the study, as we look to deliver less-invasive treatment options for patients at risk of sudden cardiac arrest,” said Ian.
He noted that the results demonstrated the potential for the novel technology to be used as a safe, successful approach for patients with life-threatening Arrhythmias.
These pivotal data mark the start of a new era in ICD therapy for patients who are at significant risk of dangerously fast heart rhythms
In the trial, 356 patients were enrolled at 46 sites spread across 17 nations in the Middle East, North America, Asia, Australia, Europe, and New Zealand.
The EV ICD system achieved 98.7% efficacy in administering defibrillation therapy, exceeding the pre-established performance goal of 88%.
In comparison to earlier transvenous ICD tests, the company claimed that the data show greater defibrillation efficacy for the EV ICD.
At six months, 92.6% of patients in the trial had relief from significant systemic or procedure-related problems, exceeding the trial’s safety objective.
“These pivotal data mark the start of a new era in ICD therapy for patients who are at significant risk of dangerously fast heart rhythms,” said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business.
He highlighted that the findings are an important clinical milestone toward their goal of delivering a one-system, one-procedure extravascular ICD solution that prevents sudden cardiac arrest.
The EV ICD system retains the benefits of a completely extravascular system while providing ATP, pause prevention pacing, and low defibrillation energy.
Medtronic has received FDA approval for a Continued Access Study while the agency reviews the company’s EV ICD pre-market application.
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