Procedural safety

Procedural safety


WATCHMAN FLX shows favorable safety and efficacy outcomes

The PINNACLE FLX US IDE Trial was designed to establish the Procedural Safety and LAA Closure Efficacy with the WATCHMAN FLX Device in 400 patients in 29 US sites.4

WATCHMAN Left atrial appendage devices confirm favorable safety outcomes in real-life studies and clinical trials

The PINNACLE IDE trial demonstrated high procedural success also for the next generation LAA closure device WATCHMAN FLX. The procedure success is consistent with recent WATCHMAN studies.

PROCEDURAL SUCCESS

PROCEDURAL SUCCESS

*Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA.
Reported N values on this slide are those of attempted implants. All cancelled procedures are excluded from this analysis.

1. Late Breaking Clinical Trial at CRT 2022, Presented by Dr. Samir Kapadia.
2. Kar, PINNACLE FLX; 12 Month Outcomes, CIRCULATION, 2021.
3. Ellis, Structural Heart, 2021.
4. Korsholm, WM FLX First Experience, JACC, 2020.
5. Bergmann, Alster-Registry, Presented ePCR 2021.
6. Betts, Poster Presentation HRS, 2021.
7. Galea, SWISS-APERO Trial, CIRCULATION, 2021.

Learn More
--:-- Discussion of the PINNACLE FLX Clinical Trial

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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.


Low complication rates demonstrated in recent clinical trials and real-life studies

Serious adverse procedure or device related events (SAE) at 7 day

Learn more about the EWOLUTION registry

EWOLUTION (Registry on WATCHMANTM Outcomes in Real-Life Utilization) is the largest prospective real-life LAAC registry with over 1.000 patients studied. The EWOLUTION registry is a multicentre study designed to obtain clinical data on procedural success, complication rates, incidence of stroke, bleeding, and long-term patient outcomes.

--:-- Acute safety results presented by Dr. Boersma

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Dr. L. Boersma

Acute safety results presented by Dr. L. Boersma

--:-- E<em>W</em>OLUTION Prospective Registry on WATCHMAN LAAC device: 3 months results and clinical impact

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Prof. Bergmann

EWOLUTION Prospective Registry on WATCHMAN LAAC device: 3 months results and clinical impact

--:-- video Dr. Bergmann insights on the EWOLUTION Study

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Prof. Bergmann

Listen to Prof. Bergmann's insights into the EWOLUTION study

--:-- The importance of EWOLUTION for implanters and the referring community

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Prof. Ghanem

The importance of EWOLUTION for implanters and the referring community


Learn more about the NCDR-LAAO REGISTRY™

The NCDR-LAAO Registry with >38,000 patients is the largest LAAC procedure data in the world in a high-risk patient population and confirms low acute adverse event rates 

--:-- NCDR-LAAO Registry Data Analysis Interview

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LAACLUB Logo

To learn more about Watchman FLX, register for free to our LAACLUB series

Register to our LAACLUB sessions

REFERENCES
* Implant success defined as deployment and release of the device into the LAA; no leak ≥ 5 mm
1. WATCHMAN FDA Panel Sponsor Presentation. Oct 2014.
2. Boersma, et al, Heart Rhythm, Vol 14, No 9. September 2017.
3. Freeman, JACC, March 2020, Vol 75, No. 13, 2020.
4. Doshi SK, et al. PINNACLE FLX Results Presented at HRS 2020.

CAUTION:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device.
Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries.
This material not intended for use in France.

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