FDA Approves New Catheter for Intrathecal Baclofen

Emma Hitt, PhD

September 14, 2012

September 14, 2012 — The US Food and Drug Administration (FDA) has approved a new catheter (Ascenda, Medtronic Inc) for use in the delivery of intrathecal baclofen (ITB) therapy.

According to the manufacturer, ITB therapy has been found in clinical trials to reduce the incidence of severe spasticity. The device is used to treat chronic, intractable pain and severe spasticity associated with cerebral palsy, multiple sclerosis, spinal cord and traumatic brain injuries, and stroke.

During ITB therapy, an implantable, programmable pump (SynchroMed II, Medtronic) delivers a continuous baclofen injection (Lioresal Intrathecal, Medtronic) by way of the newly approved Ascenda catheter.

The approach is intended to require less medication and potentially fewer side effects than oral baclofen treatment. "This may present an alternative for patients who do not respond to or cannot tolerate therapeutic oral doses," the manufacturer states.

The intrathecal catheter is inserted at the midlumbar region of the spine using a paramedian-oblique method and then advanced, typically under fluoroscopy, to the lower thoracic spine. After position and flow are verified, the catheter is anchored to spinal ligaments. The pump is placed no more than 2.5 cm beneath the skin, and the catheter is then connected to it.

The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space; catheter break/cut; and implant site infection, including meningitis, the statement notes.