Technology | February 20, 2008

Spinal Discography Device Receives FDA Clearance

Pinyons Medical Technology Inc. recently received FDA clearance to market the PowrSyringe Monitor for use in discography procedures where it can be used as a diagnostic tool to physiologically determine if a diseased, herniated, or abnormal vertebral disc in the spine is causing discogenic back pain prior to treatment.

The PowrSyringe Monitor is a one-piece disposable hand-held medical device to deliver ergonomic and mechanical advantages to a high-pressure syringe for use in diagnostic discography. The PowrSyringe Monitor is similar to the previously FDA cleared PowrSyringe Injector with integrated crossing handles that advance the plunger into the barrel when the handles are squeezed by a clinician.

Many clinicians currently use high-cost, customized two-handed angioplasty balloon inflation devices to deliver and monitor pressure during discography procedures. These two-handed devices typically use a screw-auger type plunger to generate pressure and do not provide the clinician with tactile feedback for the injection.