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

Posted on: Tuesday, 15 January 2008, 09:01 CST

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.

The new P.A.S. PORT® T2 POWER P.A.C. system also provides increased flexibility for clinicians since it can be placed in either the arm or chest. An arm port may be recommended by a clinician when chest port placement for the patient is not advised or the patient prefers the modesty of arm port access to receive their medications.

PORT-A-CATH® and P.A.S. PORT® POWER P.A.C. systems are just a few of the many products available from Smiths Medical. Their Deltec vascular access systems offer over 40 different types and sizes of ports to meet the needs of a wide range of therapies and patient sizes. With millions of systems implanted worldwide, the PORT-A-CATH®, P.A.S. PORT®, and ProPort® systems are still known as the gold standard for being easy to insert and easy to maintain during therapy. Smiths Medical also offers three types of huber needles in over 70 different sizes. Their GRIPPER®, GRIPPER PLUS®, and the latest addition GRIPPER PLUS® POWER P.A.C. safety huber needles offer many choices for clinicians.

Smiths Medical

Smiths Medical is a supplier of specialist medical devices to global markets. Smiths Medical comprises three product groupings: Safety Devices, Vital Care and Medication Delivery & Patient Monitoring (MDPM). Smiths Medical customers include hospitals and other healthcare providers worldwide. Smiths Medical employs nearly 7,500 people. For further information visit www.smiths-medical.com

Smiths Group

Smiths is a global technology company listed on the London Stock Exchange. A world leader in the practical application of advanced technologies, Smiths Group delivers products and services for the threat & contraband detection, medical devices, energy and communications markets worldwide. Our products and services make the world safer, healthier and more productive. Smiths Group employs more than 20,000 people in over 50 countries. For more information visit www.smiths.com

Source: Business Wire

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