WATCHMAN FLX™

Left Atrial Appendage Closure Device

WATCHMAN PINNACLE FLX™ Left Atrial Appendage Closure Device

Built off the most studied, most implanted LAAC device in the world, WATCHMAN FLX is a proven alternative to long-term OAC therapy1 for stroke risk reduction in patients with non-valvular atrial fibrillation.

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 the next generation LAAC device, WATCHMAN FLX.

Videos

PINNACLE FLX Late-Breaker Clinical Trial Presentation, presented by Dr. Shephal K. Doshi INSIDE SCOOP: Discussion of the PINNACLE FLX Clinical Trial with Dr. Kenneth Stein & Dr. Ian Meredith

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Surpass Early Results

The SURPASS analysis of the NCDR-LAAO Registry™ includes the largest number of commercial WATCHMAN FLX patients to date. This data reinforces the outstanding safety of WATCHMAN FLX with 0.37% major procedural adverse event rate within 7 days or hospital discharge and 98% procedural success rate in > 16,000 real-world NVAF patients.1

Study Design

  • SURPASS assesses the safety and efficacy outcomes in patients in the NCDR-LAAO Registry that received a commercial WATCHMAN FLX device
  • This SURPASS analysis includes 16,048 patients receiving a WATCHMAN FLX device between August 5, 2020 and March 31, 2021
  • SURPASS will continue to assess WATCHMAN FLX patients included in the NCDR-LAAO Registry from August 2020 through August 2022 and will follow these patients through 2 years post-implant.

Mean baseline patient characteristics (N=16,048)

  • Average age/years: 76.1 ± 7.9
  • CHA2DS2-VASc: 4.8 ± 1.5
  • HAS-BLED: 2.4 ± 1.0
  • 40% women
  • 62% with prior clinically relevant bleeding event
Safety Endpoint
 

SURPASS demonstrated 0.37% major procedural adverse event rate within 7 days or hospital discharge in 16,048 commercial patients and confirmed the trusted safety profile of WATCHMAN FLX in real-world clinical practice setting.
Safety Endpoint
 
SURPASS data reinforces WATCHMAN FLX procedural success with 98% of patients implanted (N=16,048/16,446)1 across nearly all anatomies in a real-world setting, confirming that WATCHMAN FLX real world experience replicates clinical trial outcomes.

98% people icons

 

The SURPASS Data reinforces the excellent safety profile WATCHMAN FLX demonstrated in the PINNACLE FLX Trial, with the largest (n=16,048) real-world WATCHMAN FLX patients studied to date.

 

Comparison with PINNACLE FLX2
45-Day Outcomes

Comparison with PINNACLE FLX
 

Surpass 1 Year Results

The SURPASS 1 Year Outcomes analysis of the NCDR-LAAO Registry™ now includes the largest number of commercial WATCHMAN FLX™ Device patients to date. These data continue to support the best-in-class safety of the WATCHMAN FLX Device with a 0.49% major procedural adverse event rate within 7 days or hospital discharge (whichever is later) and 98% implant success in >66,000 real-world NVAF patients.

Study Design

  • The objective of this SURPASS analysis is to assess long term safety and efficacy outcomes at one year with WATCHMAN FLX in a routine, real-world setting.​​
  • This analysis includes the largest commercial WATCHMAN FLX patient population to date, with 66,894 patients implanted between August 5, 2020 and March 31, 2022. ​

Patient Characteristics:

  • Age: 76.2 ±7.9 Years​
  • CHA2DS2-VASc Score: 4.8±1.5
  • ​HAS-BLED Score: 2.4±1.0​
  • Women: 41%​
  • Clinically Relevant Bleeding: 57.7%
Safety Endpoint
 
 
The 0.49% major procedural adverse event rate within 7 days or hospital discharge demonstrated in the SURPASS 1 Year Outcomes analysis further supports the unmatched safety profile observed in separate controlled and real-world analyses.​
37% icon and graph.
 
 
SURPASS data reinforces the WATCHMAN FLX Device procedural success with 98% of patients implanted (N=66,894)1 across nearly all anatomies in a real-world setting, confirming the WATCHMAN FLX Device real world experience replicates clinical trial outcomes.  
Procedural Success graph.
 
 
The WATCHMAN FLX Device delivers proven stroke reduction in the largest and highest-risk patient population studied to date.​
Stroke statistics and orange brain icon.
1. Late Breaking Clinical Trial at CRT 2023, Presented by Samiar Kapdia.​
2. Kapadia, CRT 2022.
3. Kar, Circulation 2021.
4. Della Rocca et al. Heart Rhythm 2022.
5. Ellis, Heart Rhythm, 2021.
6. Korsholm, WM FLX First Experience, JACC, 2020.​
7. Bergmann, Alster Registry, Presented ePCR 2021. ​
8. Betts, EHRA 2022. ​
9. Galea, SWISS APERO Trial, Cirulation, 2021. ​
10. Freeman, HRS 2022​​.

Meta-analysis

Study Design

  • Meta-analysis (published in Heart Rhythm) of 4186 patients from 21 studies (a meta-analysis is a statistical technique used to systematically merge the findings of previous studies to calculate an overall or ‘absolute’ effect)
  • 3187 Amulet implants
  • 999 WATCHMAN FLX implants
  • No difference in TE risk between groups
  • CHA2DSC2-VASc: 4.3±1.5 for Amulet
  • CHA2DSC2-VASc 4.2±1.5 for WATCHMAN FLX
  • Data from a first imaging study performed within 3-month were used to assess the incidence of peri-device leaks >5mm and device-related thrombosis (DRT).

Safety Endpoint

Safety endpoint was the occurrence of death, stroke, major bleeding, myocardial infarction, major vascular complications, device embolization, or pericardial effusion within 7 days post-procedure.

 
The largest comparison of peri-procedural success and short-term outcomes of WATCHMAN FLX vs. Amplatzer Amulet reveals superior procedural safety, higher procedural success, and better LAA closure with WATCHMAN FLX.

 

Key Results
Safety

Adverse Events graph
  • WATCHMAN FLX  superior on primary safety endpoint (0.6% FLX vs 4.7% Amulet, p<0.01) 
  • WATCHMAN FLX  superior on overall pericardial effusion/tamponade (0.1% FLX vs 2.5% Amulet, p<0.01) 
  • WATCHMAN FLX  superior on clinically relevant pericardial effusion/tamponade (0.01% FLX vs 0.7% Amulet, p=0.01) 
  • WATCHMAN FLX  superior on peri-procedural major/intracranial bleeding (0.1% FLX vs 2.3% Amulet, p=0.01) 
  • 0 device embolizations occurred with WATCHMAN FLX vs. 15 with Amulet 
  • WATCHMAN FLX demonstrated lower DRT than Amulet (1% vs 1.6%) 
  • No difference was observed for death or stroke between groups 

 

Simplicity

WATCHMAN FLX showed a trend towards higher procedural success (p=0.08). Procedural success was achieved in 99.9% of WATCHMAN FLX patients (99.4% for Amulet, P=0.08)

Seal 

WATCHMAN FLX showed a trend towards more frequent appendage occlusion (leaks >5mm; p=0.06). WATCHMAN FLX demonstrated fewer peri-device leaks >5mm than Amulet (0.01% vs 0.34%, p=0.06)

Peri Device
Della Rocca et al, Procedural and Short-Term Follow-Up Outcomes of Amplatzer Amulet Occluder versus WATCHMAN FLX Device: A Meta-Analysis, Heart Rhythm 2022.
Kapadia, SURPASS Registry, CRT 2022
 

SEAL FLX

SEAL FLX is the first study that compares complete occlusion results of the WATCHMAN FLXTM device and the AmplatzerTM AmuletTM device exclusively, using cardiac computed tomography (CT)1.
 

Study Design

  • Single-center, retrospective study of LAAO implantation at Aarhus 
 University Hospital (Denmark) between 2018-2020.
    1st cohort: Amplatzer Amulet (n=150) 2018 – 2019
    2nd cohort: WATCHMAN FLX (n=150) 2019 – 2020
  • Cardiac CT was performed 8 weeks after LAAO
Primary Outcome Complete Seal* Based on CT Imaging
 

WATCHMAN FLX Demonstrated Statistically Superior Complete Occlusion** vs Amulet (p=0.001)

Complete Occlusion* at 8 Weeks (per CT)

Complete LAA Occlusion graph

Complete Occlusion* on CT Imaging1

Primary Outcome Complete Seal* Based on CT Imaging
*Complete closure is defined as no visible peri-device leak (PDL) via TEE
**Complete LAA occlusion defined as no visible peri-device leak (PDL) and absence of contrast patency in the distal LAA (LAA/left atrium Hounsfield ratio <0.25)
 

More Leak Pathways with a Two-Component Device at 8 Weeks (per CT)
Peri-Device Leak

Peri Device Leak graph

Leak Measurements were Significantly Larger with Amulet than WATCHMAN FLX (p=0.008) at 8 Weeks (per CT)
Leak Size (mm2)

Peri Device Leak graph
 

Simplified Sizing

WATCHMAN FLX

WATCHMAN FLX sizing icon

Single Landing Zone and Overlapping Treatment Ranges

AMPLATZER AMULET2

Amplatzer Amulet sizing icon

Complicated, Mis-Matched Measurements

Simplified Placement

WATCHMAN FLX

WATCHMAN FLX placement icon

Precision Placement Control

AMPLATZER AMULET3

Amplatzer Amulet placement icon

Trade-off Between Disc and Lobe Placement

Simplified Assessment

WATCHMAN FLX1

WATCHMAN FLX assessment icon

Full Visibility

AMPLATZER AMULET1

Amplatzer Amulet assessment icon

Hidden Leaks

1. Korsholm et al, Left Atrial Appendage sealing performance of the Amplatzer Amulet and Watchman FLX device, Journal of Interventional Cardiac Electrophysiology 2022
2. Lakkireddy, Amulet Tips and Tricks in Simple and Complex Anatomy, TVT 2018.
3. Saw, Cardiac CT angiography for device surveillance after endovascular left atrial appendage closure, European Heart Journal - Cardiovascular Imaging
 

SWISS-APERO

Comparison of Amulet vs Watchman/FLX Devices in Patients Undergoing Left Atrial Appendage Closure - SWISS-APERO

Discover more on JAAC

 

 


PINNACLE FLX

PINNACLE FLX

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


DRT*

DRT at 12 months follow-up
*Device-Related Thrombus
**Doshi SK. Primary outcome evaluation of a next generation LAAC device: the PINNACLE FLX trial. Presented on: May 8, 2020. HRS 2020.


Designed to Treat Widest Range of Patient Anatomies

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

WATCHMAN FLX Device Sizes


ICE LAA

The I Can See Left Atrial Appendage (ICE LAA) assesses the use of ICE imaging of the LAA during WATCHMAN FLX implantation.

Study Design

ICE LAA is a multi-center study with core-laboratory adjudication, this analysis reported the 45-days results from 100 real-world WATCHMAN FLX patients from 7 European centers.

Summary of the Results

  • 100 real-world, European WATCHMAN FLX patients (from 7 implanting centers)
  • 100% Device Success (Implantation of WATCHMAN FLX without in-hospital mortality)
  • 100% Technical Success (Successful deployment and release, no conversion to TEE and effective closure of LAA at implant [no leak <5mm])
  • 0% Conversion to standard TEE during implant
  • 0%  leak >5mm
  • Key 45-days safety outcomes:
    • 1% all-cause death
    • 0% all stroke
    • 0% pericardial effusion
    • 0% DRT
    • 0.% device embolization
    • 3,1% major bleeding (BARC 3/5)

 

Outcomes with WATCHMAN FLX using Intracardiac Imaging: Results from ICE LAA

Jens Erik Nielsen-Kudsk
Aarhus University Hospital,
Aarhus, Denmark

Sergio Berti
Fondazione Toscana Gabriele Monasterio
Massa, Italy

Francesco Caprioglio
Ospedale San Bortolo
Vicenza, Italy

Frederico Ronco
Ospedale Dell Angelo
Mestre, Italy

Dabit Arzamendi
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain

Timothy Betts
John Radcliffe Hospital
Oxford, UK

Claudio Tondo
Centro Cardiologico Monzino
Milan, Italy

Thomas Christen
Boston Scientific
Marlborough, MA USA

Dominic J Allocco
Boston Scientific
Marlborough, MA USA

Objective

The I Can sEe Left Atrial Appendage (ICE LAA) study will assess the use of ICE imaging of the LAA during WATCHMAN FLX implantation

Background

  • The left atrial appendage (LAA) can vary greatly in volume and shape in different patients
  • Transesophageal echocardiography (TEE) is the most commonly used diagnostic modality for visualizing the LAA during WATCHMAN implantation
  • TEE carries some risk (e.g. aspiration, esophageal lesions) and typically requires a trained echocardiographer and general anesthesia.
    • Not all patients are physically able to undergo general anesthesia and/or TEERecent single-center studies have suggested LAA closure under intracardiac echocardiography (ICE) guidance is feasible and safe.
  • ICE LAA is a multi-center study with core-laboratory adjudication


Methods

Study Type: Prospective, non-randomized, single-arm, multi-center

METHODS
Table 1: Baseline Characteristics
Age, years 76 ± 8 CHA2DS2-VASc score 4.0 ± 1.5
Female 33% HAS-BLED score 2.5 ± 0.9
Indication for LAAC History of major or minor bleeding 75%
History of major bleeding 63%
Increased risk for bleeding 32%
Inability to take OACs (not related to bleeding) 23%
Thromboembolic event and/or documented presence of thrombus in LAA despite adequate OAC therapy 4%


Results

Figure 1: 1° Endpoint - Effective closure

  • The 1° endpoint of ICE LAA was significant peri-device leak (>5 mm) based on the 45-day post-implant TEE and assessed by the echocardiographic core laboratory
  • The 1° endpoint was met. The rate of leak >5 mm was 0.0% with an upper one-sided 95% confidence interval of 4.8%, which is lower than the prespecified performance goal of 5.5% (P=0.01).
1° Endpoint - Effective closure
Figure 2: 1° Peri-device Leak
1° Peri-device Leak
Table 2: Procedural Outcomes
Device Success
(Implantation of WATCHMAN FLX without in-hospital mortality)

100%
Technical Success
(Successful deployment and release, no conversion to TEE and effective closure of LAA at implant [no leak <5mm])

100%
Procedural Success
(Device success plus absence of in-hospital device or procedure-related CEC adjudicated events)

96%*

Conversion to standard TEE during implant

0.0%

Total fluoroscopy time (minutes)

19.7±12.4
Procedure Time (minutes)
(time between venous access and sheath removal)

55.2±24.1

Number of Implanted/Attempted Devices

1.0±0.1

*Procedural success was not met due to bleeding at the access site (2 subjects) and groin hematoma (2 subjects); CEC = clinical events committee

Clinical Endpoints within 45 days of follow-up

  • Patient died from a cardiac arrest 10 days after an uncomplicated implant procedure. Patient had prior history of cardiac arrest as well as renal failure, CAD and stroke and the death was not considered to be related to the procedure or device
  • No patients experienced a stroke, systemic embolism, pericardial effusion, device-related thrombus, device migration or embolization
  • Three patients experienced major bleeding (BARC Type 3a)
Figure 2: 45-day Outcomes
45-day Outcomes

Summary and Conclusions

  • We found the use of ICE during WATCHMAN FLX LAA Closure Device implantation was safe for the treatment of non-valvular atrial fibrillation in the subject population studied
  • ICE-guided WATCHMAN FLX implantation demonstrated excellent procedural success, high effective LAA closure rates, and fewer short-term complications

 

ICE LAA Trial

Introduction to ICE LAA Trial

Pr. Jens Erik Nielsen-Kudsk presents the ICE LAA Trial outcomes
Watch Now

Disclosures

Clinicaltrials.gov NCT04196335. ICE LAA was funded by BSC. Disclosures- JEN-K: Principal Investigator; DA: Boston Scientific, Abbott, SMT and Ivascular. TC, DJA: full-time employees and stockholders in BSC. All other authors have no disclosures to declare. The authors thank Kristine Roy, PhD for writing/editing assistance and Wen Hsieh, PhD (paid employees of BSC) for assistance with statistical analysis.

Nielsen Kudsk, ICE LAA Trial, EuroPCR 2022

 

 

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
WATCH VIDEO
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