Medical Products > General Medical > CastAlert
Development Program: CastAlert Monitor
Client: Walgen, Inc.
caused by swelling beneath a cast can cause serious nerve damage
and, if not detected at an early stage, loss of the affected
Common non-invasive methods for detecting excessive swelling
and/or high compartment pressure, such as visually obvious
swelling, extreme pain and warm skin, often do not allow for
detection until damage has already occurred.
If properly implemented, invasive methods can detect elevated
compartment pressure accurately, but they require the insertion
of a needle and pressure sensor into the compartment.
A non-invasive, accurate, early warning system was needed
to allow for detection of rising pressure early on, so that
simple procedures, such as elevating or icing the limb, could
correct the problem before further damage occured.
Based on the clients understanding of the market, device specifications
were established, and DCI developed a non-invasive, compact, low-cost, pressure
sensing system to be applied to the limb as part of the casting process.
The device has several warning levels that
allow the patient or healthcare provider to take corrective
action as soon as pressure begins to rise, long before sensory
observation would indicate a possible problem.
As a result of DCIs laboratory tests and prototype demonstrations, Walgen
was able to obtain significant investor capital to continue the DCI development
program through to the production stage, and DCI and Walgen contracted with
another Syracuse company to manufacture the device. With DCIs participation,
the 510(k) application to FDA was approved in 30 days.