Shimadzu’s Trinias range of angiography systems gets FDA 510(k) clearance

27 March 2014 (Last Updated March 27th, 2014 01:00)

Shimadzu Medical Systems USA (Shimadzu) has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for Trinias, a new family of digital angiography solutions, comprising three systems: ceiling-mounted, floor-mounted system and a new biplane system.

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Shimadzu Medical Systems USA (Shimadzu) has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for Trinias, a new family of digital angiography solutions, comprising three systems: ceiling-mounted, floor-mounted system and a new biplane system.

The three systems incorporate Shimadzu's ultra-high-speed SCORE PRO image processing technology, which performs a real-time evaluation of noise, devices, and anatomy.

It then determines the best image quality by optimising devices and anatomy, while maintaining ALARA ('As Low As Reasonably Achievable') dose considerations for all clinical staff.

The company's SMART Design offers the intuitive functionality required to respond instantly to physician and operator commands.

According to the company, Trinias is equipped with a new 12in 'CROSSOVER' flat panel detector for multi-procedure versatility that accommodates any type of angiography procedure.

Trinias also offers a new 8in flat panel detector for cardiac-suited procedures, as well as neuro exams.

Other elements of SCORE imaging include SCORE RSM, SCORE StentView, SCORE 3D and SCORE CT.

SCORE RSM provides real-time motion correction during image acquisition, while SCORE StentView supports percutaneous coronary intervention procedures by displaying stents in a fixed position in real-time.

SCORE 3D uses Shimadzu's C-arm design and 60° per second rotation to acquire 3D images in seconds, according to the firm.

"SCORE 3D uses Shimadzu's C-arm design and 60° per second rotation to acquire 3D images in seconds."

Workstation features allow the user to view images in fly-through or semitransparent modes, or with any angle of images, the company said.

SCORE CT is an application for observing cross-sectional images of low-contrast procedures such as tumour stains, visceral anatomy, and neurointerventional planning, and more. Seven radiation dose reduction features are also included.

According to Shimadzu, the systems also have data mirroring and redundant filaments to ensure procedure continuity. The Shimadzu SCORE Imaging is designed for improved outcomes at the least amount of dose.

The ergonomically designed Trinias family features triple pivot, a six axis in line C-arm mount, and a multi-insertion ceiling suspended C-arm to meet the demands of a cath lab and the needs of a patient.

Shimadzu showcased the Trinias line as a work-in-progress at the RSNA 2013 meeting in Chicago.

According to GlobalData estimates, the US Angio Suites market was valued at $286.6m in 2012 and is expected to grow at a CAGR of 1.0% to reach $306.2m by 2019.


Image: Shimadzu receives FDA clearance for three digital angiography systems. Photo: courtesy of Shimadzu Medical Systems USA/PR Newswire.