VALUE OF CT
PRE-CT ADOPTION IS RISING
Pre-CT use is expected to double among WATCHMAN Implanters.
A majority of these Implanters want to be involved in the CT analysis themselves.
PRE-CT ADVANTAGES DURING COVID-19
Pre-CT offers additional advantages over Pre-TEE during the COVID-19 pandemic.
Advantages of Pre-CT Compared to Pre-TEE for LAAC
INCREASED PATIENT COMFORT
- No sedation
- No fasting
- Non‑invasive with no post‑procedure recovery
REDUCED EXPOSURE RISK
- Non‑aerosol generating4
- Less physician contact5
DECREASED RESOURCE UTILIZATION
- Faster throughput5 with no post‑procedure recovery
- N95/N99 not required4
- WATCHMAN Implanter Online Survey, Q2 2020. Data on file at Boston Scientific.
- Eng MH, Wang DD, Greenbaum AB, et al. Prospective, Randomized Comparison of 3D CT Guidance versus TEE Data for LAAO. CCI, 2018.
- Korsholm K, Berti S, Iriart X, et al. Expert Recommendations on CT for LAAO. JACC Cardiovasc. Interv., 2020.
- Zoghbi WA, DiCarli MF, Blankstein R, et al. Multimodality Cardiovascular Imaging in the Midst of the COVID-19 Pandemic. JACC, 2020.
- Diagnostic and Interventional Cardiology. Cardiac Imaging Best Practices During the COVID-19 Pandemic. Available at:
https://www.dicardiology.com/article/cardiac-imaging-best-practices-during-covid-19-pandemic. Accessed July 24, 2020.
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.
©2021 Boston Scientific Corporation or its affiliates. WATCHMAN and TruPlan are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All rights reserved.