Healthcare Industry News:  Balloon catheter 

Devices FDA

 News Release - October 10, 2007

FDA Clears Hand-Held Disposable Injector for Angiographic Imaging

PARK CITY, Utah--(HSMN NewsFeed)--Pinyons Medical Technology, Inc. announced it received U.S. Food and Drug Administration clearance to market the PowrSyringe Injector(TM).

The PowrSyringe Injector is a disposable hand-held device that adds ergonomic and mechanical advantages to inject and aspirate fluids including use in angiography. The Injector's crossing handles hinge to the syringe barrel and plunger to advance the plunger into the barrel when the handles are squeezed.

"The PowrSyringe Injector may improve image quality and reduce the amount of contrast media used per patient when compared to traditional control syringes used in angiography," said Bruce Murphy, M.D., Ph.D., F.A.C.C., Medical Director, Arkansas Heart Hospital, and President, Little Rock Cardiology Clinic. "The device is simple and can be used without any new capital equipment."

"The PowrSyringe bridges the gap between syringes and electronic power injectors," said Shawn Fojtik, Pinyons Chief Executive Officer. "PowrSyringes should deliver the ease-of-use, cost-effective, and tactile feedback characteristics of a syringe, plus the faster injection speed and image quality benefits of electronic power injectors."

A study including the first live use of the PowrSyringe was presented at the New Cardiovascular Horizons Meeting in September 2007 reporting faster injection speeds than syringes. Previous studies with electronic power injectors concluded that increasing angiographic injection speed can improve image quality, reduce contrast media usage, and save hospitals thousands of dollars in contrast media.

Reducing contrast media usage is also associated with a reduction in contrast induced nephropathy (CIN) that can lead to acute renal failure. Pinyons is planning further study to determine how the PowrSyringe can improve imaging, reduce contrast media, and reduce patient complications.

There are over 10 million global angiographic procedures performed per year and each exam requires one syringe or electronic power injector disposable to inject contrast media.

Pinyons is developing a family of PowrSyringe devices for angiography, Balloon catheter inflation, spinal discography & vertebroplasty, biopsy, aspiration, and other general applications where fluids are injected or aspirated through small devices to diagnose, treat, or enable other medical devices.

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