Proven Safety Outcomes
The low 0.5% event rate demonstrates the enhanced safety profile of the WATCHMAN FLX device, 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 7 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
† Based on the combined rate observed in PREVAIL(2) and CAP2(3), plus a clinically acceptable delta
PREVAIL(2) & CAP2(3) studied the WATCHMAN LAAC Device
ADVANCE PROCEDURAL PERFORMANCE
Proven Efficacy Outcomes
The WATCHMAN FLX device is designed for enhanced LAA closure which was demonstrated with 100% rate of effective LAA closure at 12 months.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
EXPAND THE TREATABLE PATIENT POPULATION
Designed to Treat the Widest Range of Patient Anatomies
* 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)
PINNACLE FLX Trial Late-Breaker Presentation
Primary Outcome Evaluation of a Next Generation LAAC Device
Presented by Dr. Shephal K. Doshi
Electrophysiologist, Providence St. John’s Health Center
May 8, 2020
HRS 2020 Science
Discussion of the PINNACLE FLX Clincial Trial
Dr. Ian Meredith
Executive Vice President, Global Chief Medical Officer, Boston Scientific
Dr. Kenneth Stein
Senior Vice President, Chief Medical Officer, Rhythm Management, Boston Scientific
LEARN MORE ABOUT WATCHMAN FLX
1. PINNACLE FLX. Doshi, SK. Results Presented at HRS 2020.
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.