The EWOLUTION 3 months results confirm the safety of the WATCHMAN™ LAAC device.
WATCHMAN™ is the most studied LAAC device in the world and is the only one with long-term clinical data from randomized trials.
The WATCHMAN clinical program consists of seven studies (initial pilot study, two randomized clinical trials (PROTECT AF and PREVAIL), the ASAP, CAP, CAP 2 and EWOLUTION registries) which included more than 3,400 patients and nearly 6000 patient-years of clinical evidence specific to the WATCHMAN Device.
The WATCHMAN™ Device can be implanted safely,4 enables patients to discontinue warfarin5 and reduces AF stroke risk comparably to warfarin.6
In addition, the WATCHMAN Device provided patients with statistically superior reductions in hemorrhagic stroke, disabling stroke, CV death and major bleeding compared to warfarin over long-term follow-up.7
Clinical data apply only to the WATCHMAN Device. Data and findings are not applicable to other LAAC devices or designs.