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WATCHMAN MAINTAINS FAVORABLE SAFETY OUTCOMES FROM CLINICAL STUDIES TO REAL-WORLD EXPERIENCE


  • Initial US commercial experience data, collected post FDA-approval, showed a 95.6% implant success rate—the highest success rate reported in the United States1-3
  • This patient population (N=3822) included more WATCHMAN patients than in the PROTECT AF and PREVAIL clinical trials and CAP and CAP2 prospective registries combined (N=1877)1,2,4
  • Half of all the procedures in the initial US commercial experience were performed by newly implanting physicians1

Implant success is defined as deployment and release of the device into the left atrial appendage; no leak ≥5 mm.1

b Refinements were made to the WATCHMAN device and procedure in the early stages of the PROTECT AF trial. Thereafter, procedural and device-related safety events decreased. The procedural/device-related safety events in the second half of PROTECT AF were 4.8% (vs 9.9% in the first half), a level of safety similar to that seen in later studies.4

COMPLICATION RATES REMAIN LOW POST FDA-APPROVAL


  • Pericardial tamponade was the most frequent major procedural complication both in clinical studies and in the initial US commercial experience1
  • The rate of pericardial tamponade for WATCHMAN implantation in the initial US commercial experience was 1.02%, comparable to the rate of pericardial tamponade in AF ablation (1.31-1.52%), another left-sided cardiac procedure1,5,6
  • Approximately two-thirds of pericardial tamponade events in the initial US commercial experience were treated percutaneously, without the need for cardiac surgery1

Learn how WATCHMAN significantly reduced major bleeding events compared to warfarin, more than 7 days post-procedure. See the efficacy data >>

IMPLANTING CENTERS


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