Hand-Held Fluid Aspiration Device FDA Cleared

October 15, 2007

PARK CITY, Utah--Aspiration Medical Technologies, LLC announced it received U.S. Food and Drug Administration clearance to market the Aspirator. The 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, force, 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 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 Aspirator is a cost-effective single-handed device to improve aspiration force and control," said Shawn Fojtik, Aspiration's Chief Executive Officer. "The 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 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.

Aspiration is developing a family of Aspirator devices for aspiration, biopsy, and other applications where fluids are aspirated through small devices to diagnose, treat, or enable other medical devices.

  

© 2010 Control Medical Technology, LLC.
  
The ASPIRE Aspirator™ is FDA 510(k) cleared for fluid aspiration but not for sale at this time. The ASPIRE Biopsy™, ASPIRE Rotational Vacuum-Assisted Biopsy™, ASPIRE Spine™, ASPIRE Hemodialysis™, and other devices are pending FDA registration and not cleared for human use at this time.   The ASPIRE Thrombus™ Aspiration Catheters & Systems are under development and not cleared by any regulatory agency for human use at this time.  

Products protected by U.S. patents #7,041,084, 7,534,234, and 7,674,247.  Other United States and International Patents Pending.

ASPIRE Aspirator, ASPIRE Biopsy, ASPIRE Spine, ASPIRE Hemodialysis, and ASPIRE Rotational Vacuum-Assisted Biopsy are Control Medical Technology, LLC trademarks.  

  
  
  
  
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