Technology | November 21, 2011

Infinitt Xelis Cardiac Software Receives FDA Clearance

November 3, 2011 — Infinitt North America announced that their Xelis Cardiac product has received clearance from the U.S. Food and Drug Administration, and is now widely available to the North American market. 

Xelis Cardiac is a 2-D, 3-D and 4-D display and analysis tool for coronary computed tomography angiography (CTA) and left ventricle analysis (LVA). It is one of several advanced visualization tools for specialized clinical applications that Infinitt markets under the Xelis name.

The system can be used as an integrated solution with the company's web-based picture archiving and communications system (PACS) or as a standalone solution. This allows any third-party PACS user to query, view and analyze DICOM studies.

The device includes three diagnostic modules: Vessel Analysis (VA), Functional Ventricle Analysis (FA) and Calcium Scoring (Ca).

Vessel Analysis

VA is a software program designed to improve visualization and analysis of coronary arteries, improving detection of abnormalities such as stenosis, soft plaque and aneurysms.

Key Features:

- Automatic removal of rib cage, auricle and ventricle

- Intelligent detection and labeling of coronary vessel

- Vessel boundary extraction

- 4-D VR/MPR display and multi-phase handling

- CPR / C-CPR (Curved Planar Reconstruction) for the traced vessels and 90 degree rotation

- Stenosis analysis

- Soft plaque analysis

- Vessel protection from sculpting tool

- Exports images and report in Microsoft Word or DICOM Send back to PACS

Functional Analysis

FA provides quantitative analysis of heart function. It analyzes ventricular volume, ejection fraction (EF), ventricle and wall thickness.

Key Features of FA:

- Automatic removal of rib cage, auricle and ventricle

- Automatic segmentation of LV contours in all views (HLA,VLA,SA)

- Automatic LV boundary with manual editing

- Auto selection of end diastole (ED) and end systole (ES) phases

- Bull's eye view with resulting values

- Cardiac functional analysis of:

     ED/ES Wall Thickness

     ED/ES Wall Intensity

     Wall Thickening

     Wall Motion

- Exports images and report in Microsoft Word or DICOM Send back to PACS

Calcium Scoring

Ca (currently under FDA 510 (k) review) detects, analyzes and measures calcium build up in the coronary arteries, a known predictor of heart disease.

Key Features of Ca:

- Identifies all coronary vessels containing calcium

- Allows quick selection and labeling of all coronary arteries

- Calculates calcium score according to threshold values (Agatston score)  

- Displays Agatston score with summary of patient's current risk status

- Exports images and report in Microsoft Word or DICOM Send back to PACS

For more information: www.infinittna.com 

 

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