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' family of implantable access systems
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
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.