The FDA granted PMA supplemental approval to Codman & Shurtleff for the Medstream programmable infusion device, an implantable infusion pump and catheter used in treatment of movement disorders.
The Medstream system delivers continuous doses of an anti-spasm drug directly to he spinal canal to relieve spasticity, a disorder affecting more than 12 million people worldwide, which is often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury, according to the company.
The regulatory win is neuromodulation market debut Codman & Shurtleff, a subsidiary of newly formed DePuy Synthes, which is itself a subsidiary of healthcare giant Johnson & Johnson (NYSE:JNJ). DePuy Synthes was formed when Johnson & Johnson folded Synthes into its DePuy business last month.
The Medstream device functions through an implanted pump, 3 inches in diameter and 1 inch thick, which is placed in the abdomen. The device features and 8-year battery life and a "ceramic drive system" that controls drug dosage to within 10% accuracy without gear, motors or rotating parts that could wear or stall, according to a press release.
The pump deliver the anti-spasm drug to the spine via the company’s Surestream catheter and dosage is programmed with a wireless controller operated by a physician.
Codman plans to make the device available through a phased U.S. launch over the next several months, according to the release.