FDA approves Medstream Programmable Infusion System for treatment of spasticity


The US Food and Drug Administration (FDA) has given approval to Codman, through a premarket application supplement, for its Medstream Programmable Infusion System, an implantable infusion pump and catheter system used in the treatment of spasticity, a movement disorder often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury.


The Medstream system, already approved in Europe, delivers a continuous and highly accurate dose of the anti-spasm drug baclofen directly to the spinal canal to relieve the severe spasticity, a condition that, according to the American Association of Neurological Surgeons, affects more than 12 million people worldwide. The new implantable system is equipped with an eight-year battery life even at high flow rates and features the Surestream Intraspinal Catheter, a kink-resistant catheter designed to deliver uninterrupted therapy.

According to the North American Neuromodulation Society, delivery of baclofen with implantable infusion devices has been shown to reduce side effects compared to oral administration of the drug. Infusion therapyis not a cure for spasticity, but may help manage its symptoms. 

“Neuromodulation is an important area in need of innovations that improve accuracy, reliability and device longevity,” said Stan Fisher, co-director, Movement Disorders and Neurorehabilitation Center, Methodist Neurological Institute and assistant professor of Neurology, Weill Cornell Medical College.

The Medstream system, according to a company release, is the first programmable infusion system to feature a Ceramic Drive System that precisely controls drug dosage. The drive system contains no gears, motors or rotating parts that can wear or stall. Medication is delivered within 10% of the programmed flow rate and the device is certified for use in 3-Tesla MRI systems.