FDA News

FDA Clears PMT's Hand-Held Fluid Aspiration Device

(Oct 15, 2007)-- Pinyons Medical Technology, Inc. announced it received U.S. Food and Drug Administration clearance to market the PowrSyringe Aspirator. The PowrSyringe Aspirator is a disposable hand-held medical device that incorporates ergonomic and mechanical advantages for fluid aspiration during a variety of medical procedures.

The use of a large syringe barrel to aspirate fluids can increase aspiration speed, suction, and volume when compared to a smaller syringe barrel. However, it takes additional user strength and force to pull plungers back when using larger barrels. Therefore, most aspiration procedures require one hand to hold the barrel and the other hand to pull the plunger back for successful aspiration.

The PowrSyringe Aspirator eliminates the need for two hands to perform aspiration. The Aspirator’s design includes handles connected to an integrated syringe barrel and plunger that pull the plunger back when the handles are squeezed.

“The PowrSyringe Aspirator is a cost-effective single-handed device to improve aspiration control,” said Shawn Fojtik, Pinyons Chief Executive Officer. “The PowrSyringe Aspirator allows clinicians to aspirate with one hand while their other hand controls an imaging probe, catheter, biopsy needle, or other related device. The Aspirator also allows the clinician to immediately increase or decrease aspiration force in line with anatomic requirements.”

Disposable syringes are used worldwide in millions of procedures per year to assist in blood clot removal; biopsy; drainage of abscesses, cysts, and plural effusions; and other procedures. The PowrSyringe Aspirator platform is open ended with universal connectors in a variety of barrel sizes that are compatible with multiple catheters, needles, and related medical devices.

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.

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