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WATCHMAN™ TruPlan™ is developed and owned by Circle Cardiovascular Imaging Inc. (Calgary, AB, Canada), and Boston Scientific is the exclusive reseller of WATCHMAN TruPlan.
WATCHMAN™ TruPlan™ CT Imaging Software
Brief Summary/Abbreviated Statement
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.
- 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.
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