PINNACLE FLX trial results
The PINNACLE FLX U.S. investigational device exemption (IDE) study was designed to establish the procedural safety and efficacy of the WATCHMAN FLX Implant.
Advanced safety
Clinically proven safe outcomes
The low 0.5% event rate demonstrates the enhanced safety profile of the WATCHMAN FLX LAAC Implant, showing a statistically significant difference to the performance goal set for similar safety endpoints in the PREVAIL trial and CAP2 registry.1
*Occurrence of one of the following events between the time of implant and within seven days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention.
Advanced procedural performance
Proven efficacy outcomes
The WATCHMAN FLX Implant is designed for enhanced left atrial appendage (LAA) closure which was demonstrated with 100% rate of effective LAA closure at 12 months.1
LAA closure at 12 months*1
NOAC discontinuation
of patients discontinued OAC after 45 days‡1
*LAA closure at 12 months is defined as any peri-device flow with jet size ≤5mm per core laboratory-assessed TEE.
†Performance goal based on the rates observed in PREVAIL(2) and CAP2(3), minus a clinically relevant delta.
‡Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA.
Procedure performance
Designed to treat more patient anatomies with greater device sizing overlap and less appendage depth needed for deployment.
6.6% of enrolled patients in PINNACLE FLX were previous WATCHMAN screen fails or case aborts, and 97% of those patients were successfully implanted with WATCHMAN FLX.4
*Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA.
†Measured maximum LAA ostium width and/or deployed closure device diameter must be ≥ 14.0 mm and ≤ 31.5 mm to accommodate available closure device sizes. LAA depth should be approximately half the labeled implant diameter or longer.
‡This figure includes both the main cohort, and roll-in patients (totaling 452 implants).
Two-year outcomes demonstrate long term safety and efficacy
Clinical outcomes between 12 and 24 months5
Low rates of major bleeding (all BARC-3)
No additional device-related thrombus (DRT), systemic embolisms, or pericardial effusions beyond those reported at one year
No device embolization with WATCHMAN FLX through two years
Additional resources for the PINNACLE FLX study
PINNACLE FLX pivotal trial results
More information about the WATCHMAN Implant
Explore WATCHMAN safety in real-world outcomes with the WATCHMAN FLX Implant.
References
1. Kar, S., et al, Primary Outcome Evaluation of the Next Generation LAAC Device: Results from the PINNACLE FLX Trial, Circulation, 2021.
2. Holmes, DR., et al, (2014). J AM Coll Cardiol 64(1): 1-12.
3. Holmes, DR., et al, JACC 2019.4. Ellis et al. Presented at AF Symposium 2020.
4. Ellis et al. Presented at AF Symposium 2020.
5. Kar S., 24-Month Outcomes of PINNACLE FLX Study with the WATCHMAN FLX™ Left Atrial Appendage Closure Device Presented as Late-Breaking Clinical Science, Presented at TVT July 21, 2021.