FDA Approves Specialty Syringes That Allow Physicians to Inject and Aspirate With One Hand

ALBUQUERQUE, N.M. -- AVANCA Medical Devices, Albuquerque, NM, announced formal FDA approval (510K authorization) to market its interventional specialty procedure syringes, the Procedur-10 and Procedur-SF.

The Procedur family of syringes allows healthcare providers to inject and aspirate with one hand while maintaining unprecedented needle stability.  These syringes offer extensive applications in medical and surgical procedures using patented reciprocal technology that allows injection and withdrawal of fluids or tissues simultaneously.  Clinical trials have shown decreased patient pain, reduced procedure time and improved provider satisfaction.

AVANCA was formed in 2004 to develop and bring to market the Procedur family of syringes and other specialized medical devices.  The company licensed the intellectual property related to these syringes from the Science and Technology Corporation at the University of New Mexico, Albuquerque, NM.

The Procedur family of syringes was invented by Wilmer L. Sibbitt, Jr., MD, professor of internal medicine at the University of New Mexico Health Sciences Center.

Sibbitt, who is also chairman and chief scientific officer of AVANCA, says the Procedur syringes have been successfully introduced into a number of typical syringe procedures including arthrocentesis, local anesthesia and joint injections with great clinical success and outstanding physician response.  The total number of procedures that can benefit from the Procedur devices in interventional radiology, gynecology, prenatal diagnosis, anesthesiology and surgery is enormous and indicates great market potential, he says.  We are currently introducing our new interventional devices into these specialized clinical markets.  All of this is really exciting for us here at AVANCA!

The company estimates the Procedur family of syringes will benefit more than 16 million procedures performed annually in the United States by reducing unnecessary injuries and saving patients and hospitals money.

AVANCA Medical Devices will introduce these products at the Society of Interventional Radiology Meeting to be held in New Orleans, March 31 through April 5, 2005.  Kathleen Kelleher, president and CEO, says the company is introducing the Procedur syringes at this meeting because of their unique benefits in image-guided procedures, especially biopsies.  The company will introduce their syringes to other medical specialties throughout the year, including maternal fetal physician specialists for use in amniocentesis procedures, and physician specialists for use in joint procedures.

D. Frank Ferguson, who is vice president of marketing and sales and is leading the commercial introduction of the products, says it is especially rewarding to introduce new medical devices and technologies that enhance patients lives and physician and clinician performance.  With the credibility of the FDA approvals, we are now in a position to implement our marketing plan.

Source: AVANCA Medical Devices