Smiths Medical receives FDA clearance for implantable injection system

30 January 2008

Smiths Medical has received 510(k) clearance from the US FDA for the PAS Port T2 Power PAC and Port-a-Cath II power PAC dual-lumen implantable access systems for repeated injection of medication and contrast media into patients.

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.

Smiths PAS Port T2 Power PAC and Port-a-Cath II power PAC dual-lumen implantable access systems
Smiths' family of implantable access systems

The new products expand the existing port line from seven to ten systems and make them available for power injections of contrast media.

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 be placed in the patient.

With the new system, power injections can now be performed through the same portal system used for other medications and, as a result, the patient is spared the discomfort of an additional needle stick and line placement. 

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