Healthcare Industry News:  Balloon catheter 

Devices Orthopaedic FDA

 News Release - November 14, 2007

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

PARK CITY, Utah--(HSMN NewsFeed)--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.,, has offices in Park City, Utah and Hallandale Beach, Florida.

Source: Pinyons Medical Technology

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