Healthcare Industry News:  computed tomography 

Devices FDA

 News Release - June 19, 2007

Smiths Medical Receives FDA Clearance for Power Injectable Ports and Safety Needles

ST. PAUL, Minn.--(HSMN NewsFeed)--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 PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Access Systems and the GRIPPER PLUS® POWER P.A.C. Safety Huber Needles. Expanding their current line of ports and needles, the new products provide a complete system with full flexibility for a variety of therapies, including the capability for power injection of contrast media.

"With seven different port configurations and eight different needle sizes, we have the largest variety of systems available for power injection," said Jim Stitt, president of Smiths Medical MD, Inc. "We know that no two patients are quite the same, and our expanded line allows clinicians to select the optimal port for their patients' specific needs. Clinicians will recognize the same proven performance in our new systems that they have come to trust from our Deltec vascular access systems."

Implantable access systems provide a route of delivery for patients requiring long-term medications such as chemotherapy. The portal is implanted under the skin and connected to a catheter that 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 use of the PORT-A-CATH® or PORT-A-CATH® II POWER P.A.C. Implantable Access System and GRIPPER PLUS® POWER P.A.C. Safety Huber Needle to allow for a higher pressure and flow rate than standard medication infusions.

The contrast media was traditionally injected through a peripheral IV or catheter that is placed specifically for this purpose. Now, with the PORT-A-CATH® POWER P.A.C. System, the contrast media can be injected through the specialized needle and portal system, eliminating the need to place an additional IV. The patient is spared the discomfort of another needle stick and line placement.

PORT-A-CATH® POWER P.A.C. systems and GRIPPER PLUS® POWER P.A.C. needles are just a few of the many port and needle 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 PORT-A-CATH® plastic hub, GRIPPER®, and GRIPPER PLUS® safety huber needles offer many choices for clinicians. With over millions sold since their introduction in 2002, GRIPPER PLUS® safey huber needles continue to be requested for their many unique features.

Smiths Medical

Smiths Medical is a supplier of specialized medical devices to global markets. Smiths Medical comprises three product groupings: Safety Devices, Critical Care and Medication Delivery & Patient Monitoring (MDPM). Smiths Medical customers include consumers, hospitals, and other healthcare providers worldwide. Smiths Medical employs nearly 7,500 people.

Smiths Group

Smiths is a global technology company, listed on the London Stock Exchange. Smiths Group is a world leader in the practical application of advanced technologies. Its products and services make the world safer, healthier and more productive. Smiths Group has three divisions focused on the high growth detection, medical devices, energy and communications markets. It employs more than 20,000 people in over 50 countries. For more information visit www.smiths.com.


Source: Smiths Medical

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