Medtronic wins FDA panel date for DIAM spine stabilization system

Medtronic (NYSE:MDT) won a date with an FDA advisory panel for its DIAM spinal stabilization system.

The federal safety watchdog’s Orthopaedic & Rehabilitation Devices panel is slated to meet Feb. 19, 2016, to consider the pre-market approval application for the DIAM system, the FDA said today. DIAM stands for “device for intervertebral assisted motion.”

The DIAM system is designed to treat lower back pain from moderate lumbar degenerative disc disease, at a single level from the L2 to the L5 vertebrae. The system is designed to act as a shock absorber for the vertebrae, placed between the spinous processes.

A pivotal study of the system is due to report preliminary data in December, according to ClinicalTrials.gov. The 306-patient trial is designed to compare treatment with DIAM to conservative care.

The DIAM system has had CE Mark approval in the European Union for at least 10 years.

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