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Smiths Medical receives 510(k) for new implantable access systems

Smiths Medical : 08 November, 2007  (New Product)
Smiths Medical has received 510(k) clearance from the US FDA for the company's Port-a-Cath and Port-a-Cath II Power PAC Implantable Access Systems as well as the the Gripper Plus Power PAC Safety Huber Needles.
Expanding their current range 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.

'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 recognise 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 PAC Implantable Access System and Gripper Plus Power PAC 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 PAC System, the contrast media can be injected through the specialised 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 PAC systems and Gripper Plus Power PAC needles are just a few of the many port and needle products available from Smiths Medical.

The company's 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, PAS 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 features.
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