Smiths Medical Receives FDA Clearance for Expansion of Power Injectable Port Line Including a New Arm Port

ST. PAUL, Minn.--(BUSINESS WIRE)--Smiths Medical, part of the global technology business Smiths Group, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the P.A.S. PORT® T2 POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Dual-lumen Implantable Access Systems. The new products expand the existing port line from seven to ten systems now available for power injections of contrast media.
Implantable access systems provide a route of delivery for patients requiring long-term medications such as chemotherapy. The portal is implanted under the skin, usually in the chest, and connected to a catheter which threads into a vein. Power-injecting is performed when a patient requires a Contrast Enhanced Computed Tomography (CECT) scan for diagnostic reasons. The power injection procedure requires a higher pressure and flow rate than standard medication infusions so an additional IV line traditionally had to placed in the patient. However, power injections can now be performed through the same portal system used for other medications, such as the PORT-A-CATH®, PORT-A-CATH® II, or P.A.S. PORT® T2 POWER P.A.C. implantable access systems. As a result, the patient is spared the discomfort of an additional needle stick and line placement.

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