Consider the proven safety profile of the WATCHMAN device

WATCHMANTM Platform safety


WATCHMAN FLX leverages the proven WATCHMAN LAAC device heritage

The first WATCHMAN FLX experiences show 5,6:

  • Very high implant success rate
  • Very low complication rates
  • Safe outcomes achievement for patients with simple to complex anatomies
  • Excellent results at follow-up
  • High degree of sealing at follow-up

 

Learn more about WATCHMAN FLX PINNACLE DATA

WATCHMAN maintains favorable safety outcomes in real-life studies

The EWOLUTION Prospective Registry showed a 98,5% implant success* rate the highest success rate reported in all WATCHMAN trials.7

The NCDR-LAAO REGISTRY™, the largest real-life data to date on >38,000 WATCHMAN  procedures, showed 98,3% implant success rate8, higher than in the pivotal trials and consistent with the more recent EWOLUTION Registry

*Acute procedural success= rate of success among procedures in which a device was deployed.
Among those with an acutely successful procedure 70 (0.2%) had device margin residual leak ≥5mm

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

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.


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 

Learn more about the WATCHMAN Clinical Programme

See WATCHMAN safety and Efficacy Papers

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.
5. Grygier M et al., The Watchman FLX: the initial Polish experience with the new device for left atrial appendage occlusion. Kardiol Pol. 2020 Feb 5. doi: 10.33963/KP.15172.
6. Nielsen-Kudsk JE et al., The Novel Watchman FLX for Left Atrial Appendage Closure. Early European Experience. Presented at TCT 2019, 25-29 September 2019.
7. Boersma LVA et al. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J 2016;37(31):2465-74.
8. Freeman, JACC, March 2020, Vol 75, No. 13, 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.