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.

Available device sizes

21 mm, 24 mm, 27 mm, 30 mm, 33 mm

Access system sheath length

75 cm

Access system outer diameter

14 Fr

Delivery system outer diameter

12 Fr

Available access system configurations

Single Curve, Double Curve, Anterior Curve

Device frame material

Nitinol alloy

PET fabric membrane material

Polyethylene Terephthalate (PET) knit fabric, 160 µm mesh

Suture (attaches fabric to frame) material

Polyester surgical suture with a polybutilate coating

Threaded insert material

Titanium

Access and delivery sheath marker band material

Platinum Iridium

Access and delivery sheath tubing material

PEBAX™

Access sheath liner material

Polytetrafluoroethylene (PTFE)

Shelf life

3 years

Sterilization

Ethylene Oxide