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.

Top 3 Advantages of Pre-CT According to WATCHMAN Implanters¹

BETTER PATIENT EXPERIENCE

BETTER UNDERSTANDING OF ANATOMY

INCREASED PROCEDURAL EFFICIENCY

Pre-CT is Capable of Assessing the Baseline Imaging Requirements for WATCHMAN™

WATCHMAN LAAC PRE-OP BASELINE IMAGING REQUIREMENTS

TruPlan Baseline Imaging Requirements Checklist

PROCEDURE BENEFITS OF PRE-CT

Each LAA is unique, and CT reveals a complete picture of the anatomy to make your procedures more predictable.

Benefits of Pre-CT Shown by Henry Ford Hospital²

100% Procedural Success with 3D-CT vs 92% with 2D-TEE

25% Lower Procedure Time with 3D-CT vs 2D-TEE

"Pre-procedural cardiac CT may improve the accuracy, efficacy and safety of LAAO."

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

"Cardiac CT may be preferred in the planning of structural heart procedures such as  TAVR and LAAC."

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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.

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.

VALUE OF CT