News | September 3, 2007

MEDRAD Introduces New Pressure-Rated Disposable For CT Power Injection

The New PRES™ Pressure-Rated Extension Set Enables Adherence to FDA Recommendation(1)

Warrendale, PA - Recently MEDRAD released the PRES Pressure-Rated Extension Set, the only extension set that is rated for computed tomography (CT) power injection and specifically approved for MEDRAD CT contrast injection systems. An extension set, which is commonly used in conjunction with IV access, is a disposable tube set that attaches the patient catheter and the power injector tubing. The U.S. Food & Drug Administration (FDA) recommends using only venous access devices that are compatible with the high pressures achieved when power injecting(2).

PRES reduces the risk of disposable extension set rupture during powered injection of contrast agent or saline when using MEDRAD's CT injection systems, including the market-leading Stellant CT Injection System.

Extension sets that are not rated for use with power injectors can leak or rupture under the high pressures and fast flow rates of CT imaging procedures. Extension set ruptures can contaminate the scan room and personnel with blood and contrast media, and require replacement of IV catheters. Using PRES allows clinicians to follow the FDA's recommendation to use only vascular access devices designed to tolerate high pressure(3).

"Power injecting contrast media into the patient through venous access devices is often a requirement for accurate CT imaging, and as the FDA recommends, clinicians should be using high pressure tolerant disposable extension sets like the new PRES Pressure-Rated Extension Set to reduce rupture risk," said Cliff Kress, senior vice president, MEDRAD CT Business Unit. "PRES will help customers reduce the risk of extension set ruptures and avoid associated inconvenience and downtime."

PRES is now available through MEDRAD's Business Enhancement Representatives by calling 800-MEDRAD-1 or through local MEDRAD Sales Representatives.

MEDRAD also introduced a set of custom adhesive tape strips designed to help clinicians use PRES quickly and easily. HandiSTRIPS secure the catheter and pressure-rated extension set to the patient and can secure a bandage at the end of the procedure. HandiSTRIPS help achieve adherence to current CDC guidelines regarding improvement of sterility when placing catheters(4).

(1)(2)(3) "Reminders from FDA Regarding Ruptured Vascular Access Devices from Power Injection." U.S. Food and Drug Administration. 2004. Available at: http://www.fda.gov/cdrh/medicaldevicesafety/tipsarticles/reminder-rvad.html. Accessed July 30, 2007.

(4) O'Grady NM, Alexander M, Dellinger EP, et al "Guidelines for the Prevention of Intravascular Catheter-Related Infections." Center for Disease Control and Prevention. 2002. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5110a1.htm. Accessed July 30, 2007.

SOURCE: MEDRAD, Inc.