WATCHMAN FLX - Clinical Evidence

PINNACLE FLX Pivotal Trial Results

The PINNACLE FLX US IDE Clinical Study was designed to establish the procedural safety and closure efficacy of next generation LAAC device, WATCHMAN FLX

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ADVANCE SAFETY

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 Performance

Broad Range of Anatomies

NOAC Discontinuation

* 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

INSIDE SCOOP:
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

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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.