Healthcare Industry News:  EZ-IO 

Devices FDA

 News Release - January 10, 2007

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

Body Site Access to Help EMS Personnel Treat Morbidly Obese Patients

SAN ANTONIO--(HSMN NewsFeed)--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 product system for access in the distal tibia for both adult and pediatric patients.

The EZ-IO provides an immediate, safe and secure method of accessing the circulation through the intraosseous (IO) route, a technique that is being used by an increasing number of emergency care personnel for resuscitation and stabilization. IO infusion accesses the central circulation through blood vessels within the bone marrow that are held open by a rigid, non-collapsible bony wall. Medications administered through the IO route reach the central circulation in about one second, equivalent to the central venous route. Recently published guidelines issued by the American Heart Association recommend that IO be used as a first alternative to peripheral IVs in cardiac arrest.

Distal tibia IO capability provides an EZ-IO insertion site just above the inside of the ankle. This is an especially important area of the body for gaining access to morbidly obese patients. The distal tibia is usually a "thinner" area of the body and will assist emergency medical service (EMS) personnel trying to establish vascular access in these patients when time is critical.

"EMS personnel often cannot start IVs in obese patients because their size obscures the veins," said Phil Faris, president and CEO of Vidacare. "Likewise adipose tissue (fat) around the normal IO access sites is often so thick that personnel can't reach the bone with the standard EZ-IO needle. Therefore, the distal tibia is of great significance for the overweight population."

The EZ-IO product system can now be used in this location, as well as the proximal humerus (the shoulder area) for adult and pediatric patients, and in the proximal tibia (the area below the knee) for adult and pediatric patients. FDA approval of the EZ-IO for use in the distal tibia increases options for emergency medical professionals in obese patients, and for the military in their treatment of battlefield casualties.

About Vidacare

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. EZ-IO's superior design yields an ease of use that allows vascular access with minimal trauma to the patient's tissue or bone. Its 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. 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. 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, Vidacare was founded in 2001. For more information, visit www.vidacare.com.


Source: Vidacare

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