The FDA has given Aesculap Implant Systems, a unit of B. Braun Medical, clearance to market the activL, an artificial disc designed to treat single-level lumbar degenerative disc disease patients who have failed at nonoperative therapy for at least six months. The device is intended to be used as a substitute for spinal fusion procedures.
The FDA has granted Interventional Spine clearance for the Lateral Opticage Expandable Intervertebral Body Fusion Device. The device, used together with autogenous bone graft, was developed to treat patients suffering from degenerative disc disease in one or two contiguous levels of the lumbar spine.
Southern Spine has obtained FDA clearance and CE mark approval to market its StabiLink MIS Spinal Fixation System. The device is implanted via incisions of up to 4 centimeters and is intended for use in lumbar fusion surgeries to treat trauma, spinal tumors, degenerative disc disease and other conditions.
The FDA has given 510(k) clearance to Orthofix International's Pillar SA spine interbody device, which is designed to eliminate the need for supplemental internal fixation during lumbar spinal fusion surgeries. The company also secured approval in Japan for its CentroNail line of nailing systems that are used for stabilizing leg bone fractures.
Amitiza, a drug from Takeda Pharmaceutical Co. and Sucampo Pharmaceuticals, has won FDA clearance to treat irritable bowel syndrome with constipation in women, making it the first drug to win approval for the condition. The drug -- already approved for chronic idiopathic constipation -- proved safe and effective in two studies involving 1,154 IBS-C patients, most of whom were women.