SOURCE: MEDRAD, INC.

August 30, 2007 15:00 ET

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--(Marketwire - August 30, 2007) - Today 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).

MEDRAD, INC. is a worldwide leading provider of medical devices and services that enable and enhance imaging procedures of the human body. Used in diagnostic imaging, MEDRAD's product offerings include a comprehensive line of vascular injection systems, magnetic resonance (MR) surface coils and patient care products, and equipment services. Total 2006 revenues were $478 million. MEDRAD is a 2003 recipient of the Malcolm Baldrige National Quality Award, the top honor a U.S. company can receive for quality and business excellence. The company's world headquarters is near Pittsburgh, Pennsylvania, in the United States. MEDRAD is an affiliate of Bayer AG. More company information is available at www.medrad.com.

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Cautionary statement regarding forward-looking statements.

Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and MEDRAD's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. MEDRAD, INC. undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.

(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.

Contact Information

  • For additional information contact:

    Azure Frioni
    MEDRAD CT Marketing
    412-767-2400 ext. 4278
    Email Contact

    Dan Dieter
    MEDRAD Marketing Services
    724-940-6949
    Email Contact