THE ProUroScan™ PROSTATE IMAGING SYSTEM


ProUroScan Transrectal Probe ProUroScan System (Compact Version)
The probe is used to palpate the prostate gland through the rectal wall

ProUroScan is an advanced medical imaging system that uses an array of sensors mounted on a rectal probe, a central processing unit and software and image construction algorithms to provide a clear digital visual image in full-color. The system utilizes "elasticity imaging technology" to measure and digitize organ tissue density and displacement and generates a composite metric "map" that visualizes and documents abnormalities of the prostate detected by digital rectal exam for men (DRE).  A 510(k) application for market clearance for this technology in the U.S. is anticipated to be filed with the FDA in 2009.

Aside from large-scale imaging modalities such as magnetic resonance imaging, computed tomography and nuclear medicine, which due to their cost and limited availability will not be direct competitors of the ProUroScan System, the only imaging system in common use for prostates is the transrectal ultrasound ("TRUS").  TRUS is employed by urologists primarily to guide the placement of prostate biopsy needles, but it is not considered a tool for general assessment of the prostate.

Elasticity Imaging

Elasticity imaging refers to a non-invasive analysis of tissue movement and displacement. The ProUroScan technique works by computing how tissue moves in response to pressure, thus evaluating its softness or stiffness. Sensors on the head of the probe collect a sequence of pressure patterns while the probe is pressed against the prostate. The device consequently measures the prostate’s elasticity.  Each scan produces an image of the prostate and compares elasticity measurements across the gland.

Tissue Displacement

Tissue displacement occurs anytime body tissue moves in response to pressure. As areas of abnormal tissue form within an organ, the tissue often becomes more dense and less elastic.  When pressure is applied to the organ, abnormal tissue generally exhibits less displacement than normal tissue.  This difference can be detected and measured.

A Prostate Map

The image or "map" of the prostate that is created is designed to identify variations in tissue elasticity using a specially designed rectal probe.  Once the map is created it can be utilized by the physician to assist in evaluating the results of an abnormal digital rectal exam for men and stored as an electronic record.  Tissue that is confirmed by DRE as abnormal will exhibit less elastic properties and be represented by progressively darker areas on the image of the map as compared to normal tissue.  During the real-time imaging examination, the physician can direct the probe to specific areas of interest as confirmed by DRE.  The final composite image is saved in a file as a permanent electronic record and can be conveniently retrieved to view previous test results.

Not available for Sale in the United States.
CAUTION – Investigational device.  Limited by Federal law to investigational use.
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