The US Food and Drug Administration (FDA) has cleared Codman & Shurtleff's pre market approval (PMA) application of Medstream Programmable Infusion system, designed as a treatment for spasticity caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury.
The Medstream system features an implantable infusion pump, kink-resistant Surestream Intraspinal catheter to deliver anti-spasm drug baclofen directly to the spinal canal as well as a Ceramic Drive system that controls drug dosage.
The company said the Medstream system, which is certified for use in 3-Tesla MRI systems, will be available through a phased roll out in the US over the next several months.
Codman president Laxmin Laxminarain said the Medstream system may help thousands of patients suffering from spasticity to improve function.
"We are committed to developing products that can make a meaningful difference in people’s lives and lessen the global burden of neurological disease," Laxminarain added.