The federal safety watchdog’s Orthopaedic & Rehabilitation Devices panel met Feb. 19 to consider the pre-market approval application for DIAM, which stands for “device for intervertebral assisted motion.” It’s 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.
The 11-member panel voted against recommending approval for the device, based on questions about the clinical data used to back Medtronic’s PMA application, including an animal model that showed a possible negative reaction to the foreign body of the implant, according to Healio.com.
“I did not think there was substantial evidence to say it was definitively safe when we do not entirely understand the mechanism of the spinous process resorption, and given the fact that it was a relatively early follow-up and the nature of the device, that was a concern from the safety perspective, in my opinion,” panel member Dr. Harvey Smith of the University of Pennsylvania told the website. “I thought for an implanted device that was a new design, given the spinous process resorption, the animal model data showing a reaction to the implant and also some data showing that there was some wear debris, 12 months was not a sufficient follow-up time in my opinion. I think there is clearly an effect of the study, the sponsors did a lot of work they should be commended for, tackling a difficult disease, but within the rigors of the data, as they were presented, the data just was not there in their present form to be able to vote yes for it.”
“I think the primary endpoint, as I pointed out, is mixed up and flawed with respect to its applicability to both arms. The proper emphasis on the intent-to-treat analysis was not done,” added Brent Blumenstein of Trial Architecture Consulting in Washington.
The DIAM system has had CE Mark approval in the European Union for at least 10 years.