FDA
1st April 2016

Advisory Panel Votes Against the Approval of Spinal Stabilization System

On February 19th, the FDA’s Orthopedic and Rehabilitation Devices Advisory Panel voted against the approval of the premarket application for Medtronic’s DIAM (Device for Intervertebral Assisted Motion) Spinal Stabilization implant due to a lack of clinical trial data.

Advisory Panel Votes Against the Approval of Spinal Stabilization System

On February 19th, the FDA’s Orthopedic and Rehabilitation Devices Advisory Panel voted against the approval of the premarket application for Medtronic’s DIAM (Device for Intervertebral Assisted Motion) Spinal Stabilization implant due to a lack of clinical trial data. The minimally invasive spine implant is meant to treat patients with moderate low back pain secondary to single-level symptomatic lumbar degenerative disc disease. Specifically, the system is designed to treat patients whose degenerative disc disease has not progressed far enough to warrant more invasive procedures, such as disc replacements or fusion.

During the meeting, questions regarding the product’s safety, efficacy, and risk/benefit profile were brought to the panel. With respect to safety, 4 panel members voted in favor and 7 in opposition of the DIAM. The panel also voted that the implant failed to demonstrate efficacy, resulting in 8 no, 2 yes, and 1 abstention. Lastly, 7 panel members voted that the risks of the device outweighed the benefits, and 4 members abstained.

The vote was based primarily on the results of a clinical trial which compared 97 patients who received the DIAM implant to 53 patients in a control group. While the sponsor presented positive results, several panelists stated that more data was needed to show the implant’s long-term safety and efficacy. Additionally, data from an animal model showed a possible negative reaction to the implant, raising questions about the safety of the device.

Harvey E. Smith, MD, of the University of Pennsylvania, in Philadelphia, a temporary voting member said, “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.”

 

The agency is not obligated to follow its panel’s recommendation, but normally does so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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