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Smiths Medical's dual-lumen implantable access systems receive 510(k) clearance

Smiths Medical : 15 January, 2008  (New Product)
Smiths Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for the PAS Port T2 Power PAC and Port-A-Cath II Power PAC Dual-lumen Implantable Access Systems.
The new products extend the existing port range 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 PAS Port T2 Power PAC. implantable access systems. As a result, the patient is spared the discomfort of an additional needle stick and line placement. The new PAS Port T2 Power PAC 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 PAS Port Power PAC systems are just a few of the many products available from Smiths Medical. The company’s Deltec vascular access systems offer more than 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 more than 70 different sizes. The company’s Gripper, Gripper Plus, and the latest addition Gripper Plus Power PAC safety huber needles offer more choices for clinicians.
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