Clinically proven outcomes

WATCHMAN FLXTM

Clinically proven
outcomes


The WATCHMAN Platform confirms favorable efficacy outcomes from clinical studies to real-world experience

With  almost 20 years of clinical-trial and real-world experience the WATCHMAN platform is the most studied left atrial appendage closure (LAAC) device.

Long-term results demonstrate WATCHMAN reduces stroke, bleeding and mortality

Long-term results from a patient-level meta-analysis of the PROTECT AF (2,717 pt yrs) and PREVAIL (1,626 pt yrs) trials demonstrated that WATCHMAN offered, after 5 years of follow up1:

  • Comparable stroke risk prevention vs. warfarin
  • Statistically significant reductions in disabling and fatal stroke# (55%), non-procedure related major bleeding (52%), and mortality (41% CV death) vs. warfarin
5-Year Patient-Level Meta-Analysis of PROTECT AF and PREVAIL

55 percent

Relative Risk Reduction

In Disabling and Fatal Strokes1

72 percent

Relative Risk Reduction

In Major Bleeding 6-months Post Implant2

27 percent

Relative Risk Reduction

In All-Cause Mortality1


EWOLUTION two-year results confirm that
WATCHMAN is effective in a real world setting

  • EWOLUTION, the largest prospective real-life study on WATCHMAN, showed a high success of implant and sealing, with low procedural adverse event rates3
  • > 70% of the patients in the study were deemed unsuitable for any oral anti-coagulation.3
  • Two-year results confirm that WATCHMAN is safe and effective showing:
    • 83% reduction in ischemic stroke rate (1.3 per 100 pt-yrs)4 as compared to the expected rate with no therapy.5
    • 46% reduction in non-procedural major bleeding rate (2.7 per 100 pt-yrs)4 compared to the expected rate with warfarin.6

EWOLUTION 2-year data - Prof. Lucas V.A. Boersma gives his insights

Ischemic stroke rates for the overall population and high risk subgroups
Major bleeding rates for the overall population and high risk subgroups

WATCHMAN LAAC proves to be an effective solution for stroke risk reduction in both high and low risk patients

  • In patients with CHA2DS2-VASc ≥ 3 an 82% reduction in ischemic stroke rate4 was observed vs. expected
  • No stroke occurred in patients with CHA2DS2-VASc < 3, resulting in 100% relative risk reduction4
Thrombo-embolic event rates according to patient's stroke risk

WATCHMAN exhibited a favorable effect on long-term bleeding

  • The patient-level meta-analysis of the PROTECT AF and PREVAIL trials demonstrated that the longer a patient has a WATCHMAN Implant, the greater the reduction in bleeding events.7
  • At 6 months post-procedure, WATCHMAN reduced major bleeding events vs warfarin by 72% (1.0 vs 3.5; P<0.001).7
WATCHMANTM significantly reduced major bleeding* > 7 days post-procedure7

In the ASAP prospective registry, WATCHMAN demonstrated efficacy in stroke risk reduction in patients contraindicated for oral anticoagulants8

Ischemic Stroke

Proven Safety

Review safety data from clinical studies and real-life registries, showing overall implant success rates for WATCHMAN.

View Safety Data

REFERENCES
* Effectiveness in stroke reduction vs. estimated in the absence of therapy for comparable CHA2DS2-VASc scores based on Friberg et al. EHJ 2012
# Two strokes in PREVAIL are excluded because the baseline MRS score was unavailable 1 Reddy VY et al., 5-Year Outcomes After Left Atrial Appendage Closure From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975.
1. Reddy VY, Doshi SK, Kar S, et al., 5-Year Outcomes After Left Atrial Appendage Closure From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975.
2. Price MJ, Reddy VY, Valderrábano M, et al. Bleeding outcomes after left atrial appendage closure compared with long-term warfarin: a pooled, patient-level analysis of the WATCHMAN randomized trial experience. JACC Cardiovasc Interv. 2015;8(15):1925-1932.
3. Boersma LV et al., Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-Year follow-up outcome data of the EWOLUTION trial. Heart Rhythm. 2017 Sep;14(9):1302-1308.
4. Boersma LV et al., Stroke, bleeding and mortality of WATCHMAN Left Atrial Appendage Closure in Patients with or without Contraindication to Oral Anticoagulation: 2-year final outcome data of the EWOLUTION Study. Presented at EHRA 2018.
5. Friberg L, et al., Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. European Heart Journal (2012) 33, 1500 -1510.
6. Lip GYK, et al., Comparative Validation of a Novel Risk Score for Predicting Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation. J Am Coll Cardiol. 2011 Jan 11;57(2):173-80.
7. Price MJ, et al., Bleeding outcomes after left atrial appendage closure compared with long-term warfarin. JACC Cardiovasc Interv. 2015;8(15):1925-1932.
8. Reddy VY, et al., Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). JACC.2013 Jun 25;61(25):2551-6

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.