Boston Scientific (BSX) reported the final results from the UNTOUCHED study of the EMBLEM Subcutaneous Implantable Defibrillator, or S-ICD, System, an approved implantable defibrillator for primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction. The trial data demonstrated safety and efficacy of the S-ICD System. In the trial, S-ICD therapy had an inappropriate shock-free rate of 95.9% at 18-months post-procedure, meeting the primary endpoint with a rate comparable to or lower than those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies.
Also, results from the investigator-sponsored PRAETORIAN trial were announced. Investigators confirmed that the S-ICD can be the preferred therapy choice for the majority of ICD-indicated patients without a need for pacing as it offers comparable performance while avoiding lead-related complications and serious infections associated with TV-ICDs.
Separately, Boston Scientific reported positive 12-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the WATCHMAN FLX Left Atrial Appendage Closure Device for patients with non-valvular atrial fibrillation. The trial met primary safety and efficacy endpoints with low complication rates, 100% effective closure with next-generation stroke risk reduction technology.
The next-generation WATCHMAN FLX device received CE Mark in 2019. The company plans to further evaluate the WATCHMAN FLX device through continued enrollment in the ongoing OPTION trial as well as in the CHAMPION-AF clinical trial.
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