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Cost-Effective Spinal Discography Device Receives FDA Clearance: Pinyons Medical Technology's PowrSyringe Expands With New Spine Indication

Pinyons Medical Technology, Inc. announced it received U.S. Food and Drug Administration (FDA) clearance to market the PowrSyringe Monitor™ for use in discography procedures.

Discography is 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.

"The PowrSyringe Monitor™ is a simple single-handed and cost-effective device that may be used for discography," said Shawn Fojtik, Pinyons Chief Executive Officer. "Single-handed pressure delivery during discography with tactile feedback can be an important safety advantage and help improve patient care."

Pinyons is developing a family of cost-effective PowrSyringe devices for angiography, balloon catheter inflation, spinal discography & 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. PowrSyringe Monitor™ with digital manometer is under development. U.S. and foreign patents are issued and pending on the PowrSyringe Injector, Monitor, and Aspirator.

Pinyons Medical Technology, Inc., http://www.pinyonsmedical.com, has offices in Park City, Utah and Hallandale Beach, Florida.

Pinyons Medical Technology





Rentabile spinãrii Discografie Aparat Primeºte FDA Clearance: Pinyons Medical Technology a PowrSyringe extinde cu noi Spine Indicarea - Cost-Effective Spinal Discography Device Receives FDA Clearance: Pinyons Medical Technology's PowrSyringe Expands With New Spine Indication - articole medicale engleza - startsanatate