News | November 14, 2007

Spinal Discography Device Receives FDA Clearance

November 15, 2007 – 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.

With the PowrSyringe Monitor, the clinician can control pressure with one-hand allowing their second hand to control catheters, needles, imaging, or other devices with tactile feel for the injection.

Pinyons said it is developing a family of cost-effective PowrSyringe devices for angiography, balloon catheter inflation, spinal discography and vertebroplasty, biopsy, aspiration, and other general applications where fluids are injected or aspirated, with and without pressure monitoring, to diagnose and treat patients or enable other medical devices.

The PowrSyringe Monitor is expected to be available for commercial sale in early 2008.

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