WATCHMAN™ TruPlan™ CT Imaging Software Brief Summary

WATCHMAN™ TruPlan™ is developed and owned by Circle Cardiovascular Imaging Inc. (Calgary, AB, Canada), and Boston Scientific is the exclusive reseller of WATCHMAN TruPlan.

INDICATIONS FOR USE

WATCHMAN TruPlan enables visualization and measurement of structures of the heart and vessels for:

Pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure
Post-procedural evaluation for the LAAC procedure

To facilitate the above, WATCHMAN TruPlan provides general functionality such as:

Segmentation of cardiovascular structures
Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR
Simulation of TEE views, ICE views, and fluoroscopic rendering
Measurement and annotation tools
Reporting tools

WATCHMAN TruPlan’s intended patient population is comprised of adult patients.

IMPORTANT

TruPlan is intended to be used as a pre-procedural planning aid, and LAAC procedures should be performed per the chosen LAAC device’s approved IFU.
TruPlan is intended to be used as a post-procedural assessment aid, and all clinical decisions should be made per the chosen LAAC device’s approved IFU.

CONTRAINDICATIONS

None known.

WARNINGS

TruPlan should not be used for purposes other than those indicated in the Indications for Use/Intended Use section.
Please review the patient and study information carefully to ensure the correct patient case is being evaluated.
The TruPlan software is not intended to perform a diagnosis, nor to replace any duties of the physician.
Measurements made in TruPlan should only provide additional information to, not replace, measurements made during the typical clinical workflow (e.g., intra-procedural imaging using fluoroscopy, TEE, and/or ICE).
The Fluoro, TEE, and ICE modules provide simulated, not real, images of fluoroscopic, TEE, and ICE views, respectively.
Quantitative analysis is dependent on the quality and correctness of the image source data (i.e, CT scans).
Software may slow down when other software applications are being run on the same machine.
Operating system updates might require an updated version of TruPlan (see System Requirements).
Any serious incident that has occurred in relation to this software as a medical device should be reported tothe Circle Cardiovascular Imaging Inc. and the competent authority of the Member State in which you are established, see Support section for contact information.

Please visit www.circlecvi.com/watchman-truplan for a summary of safety information and to download the full Directions for Use (User Manual). Rx Only.

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