Codman, now a part of Johnson & Johnson, just announced FDA clearance for its MEDSTREAM Programmable Infusion System, a drug pump that delivers baclofen to the spinal canal in a very controlled manner. The system, that already has European approval, is designed to help address chronic spasticity in patients suffering from stroke, cerebral palsy, multiple sclerosis, spinal cord injury and those post stroke suffering from excessive muscle contractions.
The implant has a ceramic pump system that doesn’t have any gears, motors, or rotating components, so it is not prone to wear and tear. The pump is also MRI compatible, a big benefit for patients that may need regular scanning during the progress of their condition. The manufacturer promises the pump’s battery will run the MEDSTREAM for eight years all while staying within 10% of the recommended delivery dose.
From the announcement:
Use of the MEDSTREAM System involves the implantation of a pump, about three inches in diameter and about one-inch thick, inside a patient’s abdomen. Baclofen is transported from the pump directly to the spinal area with the SURESTREAM Catheter. Clinicians use a computerized wireless control unit to non-invasively program dosing and flow rate for each patient based on his or her specific needs.
Delivery of baclofen with implantable infusion devices has been shown to reduce side effects compared to oral administration of the drug.[iii] Infusion therapy is not a cure for spasticity, but may help manage its symptoms.
Product pages: Medstream Programmable Infusion System; SURESTREAM Intraspinal Catheter
Press release: CODMAN RECEIVES FDA PMA APPROVAL FOR MEDSTREAM™ PROGRAMMABLE INFUSION SYSTEM…
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