WATCHMAN FLX™

Left Atrial Appendage Closure Device

WATCHMAN PINNACLE FLX™ Left Atrial Appendage Closure Device
WATCHMAN FLX is an Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.

Built off the most studied, most implanted LAAC device in the world, WATCHMAN FLX is designed for patients with NVAF who are eligible for anticoagulation therapy to reduce the risk of stroke.

WATCHMAN FLX was studied in the PINNACLE FLX US IDE Clinical Trial. The study was designed to establish the procedural safety and closure efficacy of next generation LAAC device, WATCHMAN FLX.

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PINNACLE FLX

PINNACLE FLX LATE-BREAKER PRESENTATION
Primary Outcome Evaluation of a Next Generation LAAC Device: The PINNACLE FLX Trial

presented by Dr. Shephal K. Doshi

May 8, 2020
HRS 2020 SCIENCE


PINNACLE FLX Clinical Study

The PINNACLE FLX US IDE Trial was designed to establish the Procedural Safety and LAA Closure Efficacy with the WATCHMAN FLX LAAC Device.

Study Design

  • 400 patient, 29 US site, single arm, non-randomized trial evaluating WATCHMAN FLX for non-inferiority to safety and efficacy performance goals based on the WATCHMAN™ device.
  • Follow-up: 45 days (+TEE), 6 months, 12 months (+TEE), 18 months, and 24 months
  • Patient Characteristics: Average CHA2DS2-VASc of 4.2±1.5, Average HAS-BLED of 2.0±1.0
  • Post Implant Drug Regimen: NOAC/ASA for 45 days, Clopidogrel/ASA to 6 months, ASA post 6 months
  • Primary Safety Endpoint: All-cause death, ischemic stroke, systemic embolism, or device- or procedure-related adverse events requiring surgery or major endovascular intervention within 7 days following the procedure or by hospital discharge, whichever is later.
  • Primary Efficacy Endpoint: The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months
  • Secondary Efficacy Endpoint: The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
  • Inclusion/exclusion criteria is consistent with WATCHMAN clinical study inclusion/exclusion criteria. Patients must be eligible for short-term NOAC vs warfarin in previous clinical studies.


Primary Safety Endpoints

All-cause death, ischemic stroke, systemic embolism, or device- or procedure-related adverse events requiring surgery or major endovascular intervention within 7 days following the procedure or by hospital discharge, whichever is later.
 
primary safety statistics
   
primary safety endpoint graph
* Based on the combined rate observed in PREVAIL(1) and CAP2(2), plus a clinically acceptable delta.
primary safety endpoint graph
1 Holmes, DR., et al, (2014). J AM Coll Cardiol 64(1): 1-12.
2 Holmes, DR., et al, JACC 2019.


Primary Efficacy Endpoints

The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months.

 

primary efficacy endpoint graph
*LAA closure at 12 months is defined as any peri-device flow with jet size ≤5mm per core laboratory-assessed TEE
** Performance goal pased on the rates observed in PREVAIL(1) and CAP2(2), minus a clinically relevant delta


Procedure Performance

   
98.8% Procedure/Implant Success
* Implant success defined as successful delivery and release of a WATCHMAN FLX device into the LAA


NOAC Discontinuation

   
96.2% of patients discontinued NOAC at 45-day follow-up
1 Holmes, DR., et al, (2014). J AM Coll Cardiol 64(1): 1-12.
2 Holmes, DR., et al, JACC 2019.



Designed to Treat Widest Range of Patient Anatomies

WATCHMAN FLX sizes range from (20mm - 35mm)

WATCHMAN FLX Device Sizes

 

 

PINNACLE FLX

INSIDE SCOOP:
Discussion of the PINNACLE FLX Clinical Trial

Dr. Kenneth Stein, Senior Vice President, Chief Medical Officer, Rhythm Management at Boston Scientific
Dr. Ian Meredith, Executive Vice President, Global Chief Medical Officer, Boston Scientific
Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. 
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