Ascenda, a Stronger Catheter for Medtronic’s Baclofen Synchromed II Pump

Ascenda, a Stronger Catheter for Medtronic’s Baclofen Synchromed II Pump

ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy.

Important Safety Information for ITB Therapy: Intrathecal Baclofen Withdrawal: Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).

This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.

The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or underdose. Acute massive overdose may result in coma and may be life threatening.

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. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.

Please refer to the full prescribing information and system information for details or call Medtronic at (800) 328-0810.

Medtronic has announced the upcoming launch of its silicone Ascenda Catheter for use with the company’s SynchroMed II programmable baclofen injection pump. Baclofen injection (Lioresal Intrathecal) is an option over oral administration of the drug for patients with severe spasticity.

Medtronic Ascenda Catheter Ascenda, a Stronger Catheter for Medtronics Baclofen Synchromed II PumpThe SynchroMed II pump is implanted below the skin and the Ascenda Catheter snakes from the device to the intrathecal space that surrounds the spinal cord. By directly delivering the medication to the spinal cord, side effects from the baclofen can be substantially reduced.

• The Ascenda™ Catheter was approved by the U.S. Food and Drug Administration as an innovation to improve the durability and ease of medication delivery for both Medtronic Targeted Drug Delivery and Medtronic Intrathecal Baclofen (ITB) TherapySM.

• Ascenda is a key component of the implantable SynchroMed® II system, a battery-powered programmable pump that delivers medication through a catheter directly to the fluid surrounding the spinal cord for potential relief with less medication and fewer side effects than oral treatments.

• The unique combination of a robust polymer braided design, increased anchoring strength, and an enhanced, tactile catheter connection make the Ascenda Catheter the most robust and reliable catheter available.

Source : http://professional.medtronic.com/pt/neuro/itb/index.htm#.UFriglLVYQt

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