Mon. 20 May 2024, 1:55am ET
Benzinga
News
In addition to evaluating the safety and performance of the EMPOWER LP as a standalone pacemaker, the trial evaluated the ability of the EMBLEM S-ICD System to successfully communicate a wireless request to the LP to deliver ATP therapy. Findings from the trial met all pre-specified six-month safety and effectiveness endpoints, and demonstrated:
- A major complication-free rate of 97.5% after implantation of the EMPOWER LP.1
- A communication success rate of 98.8% from the EMBLEM S-ICD System to the EMPOWER LP.2
- An ATP success rate of 61.3%,3 and no patient requests for deactivation of ATP or bradycardia pacing due to pain or discomfort.
- Pacing capture thresholds, which indicate stable device fixation within the heart, of ≤ 2.0 V at 0.4 ms in 97.4% of patients.