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

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.

To facilitate the above, 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

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

CONTRAINDICATIONS

None known.

WARNINGS

TruPlan should not be used for purposes other than those indicated in the indications for use.
TruPlan 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).
The TruPlan software may slow down when other software applications are being run on the same machine.
Operating system (OS) updates might require an updated version of TruPlan.

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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