FDA Okays First Extravascular ICD System

The device's effectiveness in delivering defibrillation therapy at implant (primary efficacy endpoint) was 98.7%, compared with a prespecified target of 88%.

There we no major intraprocedural complications, nor were any unique complications observed that were related to the EV ICD procedure or system compared to transvenous and subcutaneous ICDs.

Additionally, 33 defibrillation shocks were avoided by having anti-tachycardia pacing programmed "on."

At 6 months, 92.6% of patients (Kaplan-Meier estimate) were free from major system and/or procedure-related major complications, such as hospitalization, system revision, or death.

The Aurora EV-ICD system is indicated for patients who are at risk of life-threatening arrhythmias, who have not previously undergone sternotomy, and who do not need long-term bradycardia pacing.

The Aurora EV-ICD system is similar in size, shape, and longevity to traditional transvenous ICDs.

 

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