Shimadzu Receives FDA Clearance for Trinias Digital Angiography Systems

March 26, 2014—Shimadzu Medical Systems USA (Torrance, CA) announced the US Food and Drug Administration 510(k) clearance for the company’s ceiling-mounted Trinias, floor-mounted Trinias, and Trinias Biplane digital angiography systems. 

According to the company, Shimadzu’s ultra-high speed Score Pro image-processing technology aids workflow efficiency. Additionally, Shimadzu’s Smart design aims for intuitive functionality for instant response to physician and operator commands. The Shimadzu Score imaging process enhances the fluoroscopic image while maintaining As Low As Reasonably Achievable (ALARA) dose considerations for all clinical staff. The systems are ergonomically designed for ease of use and access, with features including Shimadzu’s interventional-designed triple pivot; a six-axis, inline C-arm mount; and a multi-insertion, ceiling-suspended C-arm.

For use as an angiographic interventional system, Trinias features a 12-inch Crossover flat-panel detector for multiprocedure versatility that accommodates any type of angiography procedure. Combined with Score Pro image processing, the systems aim to provide excellent visibility, numerous image guidance functions, and three-dimensional (3D) application techniques.

For use as a cardiac interventional system, Trinias is equipped with an 8-inch flat-panel detector for cardiac-suite procedures as well as neurovascular exams. The Score StentView function provides improved visibility of existing stents in vessels in real-time, which makes it easier to assess potential relationships between overlapping stents or when re-expanding a stent using a balloon. The real-time application now uses DICOM images and requires no special post-processing workstation.

Score RSM (using Shimadzu’s real-time smoothed mask-digital subtraction method [RSM-DSA]) allows for 100% motion correction during an acquisition. A 70% DSA image allows for anatomical accuracy during interventions, a reduced contrast and x-ray dose due to the motion correction, and high-resolution imaging.

Score 3D uses Shimadzu’s C-arm design and 60°-per-second rotation to acquire 3D images in a matter of seconds. Multiple workstation features provide users with the flexibility to view the images as fly through, semi-transparent, or with any angle of images necessary to optimize patient outcomes.

The Score CT application is for observing cross-sectional images of low-contrast procedures, such as tumor stains, visceral anatomy, neurointerventional planning, and more.

A complete system package provides sagittal, axial, and coronal slices within seconds. Shimadzu’s C-arm design allows for the best image quality due to a G-force structure that eliminates image distortion due to motion. The systems also have seven radiation dose-reduction features, data mirroring, and redundant filaments to ensure procedure continuity.