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CONSIDER WATCHMAN FOR PATIENTS WHO HAVE A REASON TO SEEK AN ALTERNATIVE TO ORAL ANTICOAGULANTS:


Appropriate patients may have one or more of the following:

  • A history of major bleeding while taking therapeutic anticoagulation therapy
  • Prior inability to maintain a stable therapeutic International Normalized Ratio (INR) or to comply with regular INR monitoring AND unavailability of an approved alternative anticoagulation agent
  • A medical condition, occupation, or lifestyle placing the patient at high risk of major bleeding due to trauma

For full information regarding WATCHMAN patient selection factors, please see the WATCHMAN Device Directions for Use (DFU)

SEE THE BENEFITS OF WATCHMAN FROM THE PHYSICIAN’S PERSPECTIVE


Watch physicians discuss how the WATCHMAN Implant offers patients with non-valvular atrial fibrillation (NVAF) an important alternative to long-term oral anticoagulant therapy

DEVICE INDICATIONS FOR USE


The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:

  • Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;
  • Are deemed by their physicians to be suitable for warfarin; and
  • Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin

Payer coverage policies may not be consistent with BSC device labeling. In some cases, payer policies may include procedures, indications or criteria (such as a specific definition of CHAD2 or CHA2DS2-VASc scores or contraindication to warfarin) which may differ from the FDA label. The Centers for Medicare and Medicaid Services (CMS) established a national coverage determination (NCD) for percutaneous LAAC therapy on February 8, 2016 – Visit www.cms.gov to review the NCD criteria in their entirety. For patients who are not covered by Medicare, please refer to the specific payer’s policy in seeking prior authorization for medical necessity for the WATCHMAN Therapy.

 

WHY WATCHMAN?


The WATCHMAN Implant is the only FDA-approved device proven to safely and effectively reduce stroke risk in patients with NVAF

  • In non-valvular AF (NVAF), >90% of stroke-causing clots that come from the left atrium are formed in the left atrial appendage (LAA)1
  • The WATCHMAN Implant has been proven to offer stroke risk reduction comparable to warfarin—and also reduces the long-term risk of bleeding associated with warfarin use

HOW CAN WATCHMAN CHANGE YOUR PATIENT’S STORY?


In the series of videos below, real patients convey how WATCHMAN has changed the way they live with NVAF, while patient cases describe potential candidates for WATCHMAN.

HEALTH PROBLEMS RESULTING FROM A FALL PUT FRANK AT RISK FOR MAJOR BLEEDING


Age: 80; Involved Grandfather; NVAF, Congestive Heart Failure, Hypertension, Diabetes

CHA2DS2-VASc score: 5; HAS-BLED score: 2

Although patient is suitable for warfarin, he is currently taking 15 mg rivaroxaban daily

Frank has a history of recurrent falls, resulting in both a broken hip and cerebral contusion after falling on separate occasions. His physician believes his medical condition places him at high risk of major bleeding secondary to trauma*

Frank's physician determined he is a potential candidate for a WATCHMAN Implant


Case description for educational purposes; not a real patient case.

*Some studies of patients with a history of falls, or at risk for falls and head trauma, have shown that the benefits of anticoagulation therapy to reduce the risk of stroke outweigh the risk of major, life-threatening bleeding. An individualized benefit and risk assessment should be made in such patients2-4

INADEQUATE CONTROL ON OACS AND MEDICATION COSTS CREATE CHALLENGES FOR CATHERINE


Age: 68; Retired, Volunteer; NVAF, Hypertension, Vascular Disease

CHA2DS2-VASc score: 4; HAS-BLED score: 3

Currently taking 5 mg warfarin and 100 mg of aspirin daily

Catherine is unable to comply with regular INR monitoring due to her proximity to the clinic and cannot afford novel oral anticoagulant (NOAC) medication

Catherine's physician determined she is a potential candidate for a WATCHMAN Implant

 

Case description for educational purposes; not a real patient case.

GWEN'S LIFESTYLE MAY ELEVATE THE RISK OF MAJOR BLEEDING


Age: 65; Home Health Aide; NVAF, Diabetes

CHA2DS2-VASc score: 3; HAS-BLED score: 3

Although patient is suitable for warfarin, she is currently taking 150 mg dabigatran twice daily

Gwen's physician determined her active lifestyle, which includes horseback riding, places her at risk of major bleeding secondary to trauma

Gwen's physician determined she is a potential candidate for a WATCHMAN Implant


Case description for educational purposes; not a real patient case.

THE COMBINATION OF JOHN WORKING AS A COMMERCIAL FISHERMAN AND HIS WARFARIN REGIMEN PROMPT CONCERNS ABOUT BLEEDING RISKS


Age: 55; commercial fisherman; NVAF, Hypertension, Diabetes

CHA2DS2-VASc score: 2; HAS-BLED score: 2

Currently taking 5mg warfarin daily

John's physician feels that his work as a fisherman puts him at risk of major bleeding secondary to trauma.

John's physician determined he is a potential candidate for a WATCHMAN Implant


Case description for educational purposes; not a real patient case.

IMPLANTING CENTERS


Do you have a patient who may be a candidate for receiving the WATCHMAN Implant?

 

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