Healthcare Industry News:  EZ-IO 

Devices FDA

 News Release - April 18, 2006

Vidacare's EZ-IO(R) Product System Receives FDA Clearance for Humeral Head Access

SAN ANTONIO--(HSMN NewsFeed)--April 18, 2006--Vidacare®, manufacturer of the EZ-IO® product system, the leading solution for immediate vascular access when conventional IV access is challenging or impossible, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the EZ-IO AD product system for use in humeral head access in patients with body weight greater than 39kg.

Humeral head intraosseous capability provides for an EZ-IO insertion site above the diaphragm, a location preferred by many emergency physicians and trauma surgeons for rapid vascular access. Multiple intraosseous access sites have proven to be especially important to the military in their treatment of battlefield casualties. Flexibility has long been the key for successful treatment of critical patients. The EZ-IO infusion system now offers that flexibility for immediate vascular access.

"FDA approval of the EZ-IO for use in humeral head access increases options for emergency medical professionals," said Philip Faris, Jr., CEO and president of Vidacare. "Multiple-site access -- the tibia and the humeral head -- will enable even greater ease-of-use of the EZ-IO system in front-line emergency situations."

Ed Racht, M.D., a nationally recognized Emergency Medical Services Physician from Austin, Texas, recently said, "The new AHA guidelines recognize the benefit of immediate alternative vascular access via the intraosseous route. As is the philosophy with many of the recommended changes, simplicity, ease of use in potentially chaotic situations and interventions that focus on flexibility and efficacy are emphasized. The addition of the humeral head access site provides a welcome new tool for use in this difficult patient population."

About EZ-IO Product System

The EZ-IO product system by Vidacare is the best product for immediate vascular access when conventional IV access is difficult or impossible. The EZ-IO facilitates the administration of fluids and drugs to the patient securely, easily and quickly. There are three keys to Vidacare's innovative product. First, the EZ-IO's superior design yields an ease of use that allows vascular access with minimal trauma to the patient tissue or bone. Secondly, the unique design allows the user to know precisely when the insertion needle has entered the intraosseous space giving them superior control, even in the most difficult cases. Finally, the EZ-IO allows emergency medicine professionals to work expertly to securely attain vascular access in seconds. The result is the ability to achieve required flow rates safely and with confidence. Further, the EZ-IO can help improve the clinical excellence of the EMS and the hospital, ultimately becoming a contributing factor in saving patients' lives. Headquartered in San Antonio, TX the company was founded in 2001. For more information, visit www.vidacare.com.


Source: Vidacare

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