FDA Ortho Panel to Consider Medtronic’s DIAM Spinal Stabilization System in February

The FDA’s Orthopaedic and Rehabilitation Devices Committee is going to meet on February 19, 2016 to consider Medtronic plc’s premarket application for its DIAM Spinal Stabilization System.

DIAM Indications

According to the FDA, the system is indicated for “skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5. DDD is confirmed radiographically with one or more of the following factors: (1) patients must have greater than 2 millimeters of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach.”

One Study Result

An October 2009 study cited by PubMed, looked at 68 patients with a degenerative disease of the lumbosacral spine. They suffered from axial pain with signs of nerve root involvement due to disc hernia, foraminal stenosis or disc herniation recurrence. They were followed up for one to three years and evaluated.

None of the patients in the study required revision surgery or had a recurrence of disc herniation. The authors also suggest that the implant protects the whole operated spinal segment, i.e., both intervertebral joints and discs, from being overloaded.

At three-year follow-up the patients reported improvement in their functional state, as measured with an ODI (Oswestry Disability Index), by 64 % on the average. Their axial and nerve root pain was reduced by 71 % on the average. All patients showed improved clinical conditions and the outcomes were evaluated as excellent in 41 %, good in 51 % and fair in 7.5 % of the patients. The results of implantation were not significantly related to age, gender, operative indications, operated lumbosacral level, method of nerve root decompression or duration of pre-operative problems.

A November 30, 2015 ClinicalTrails.gov posting said the clinical trial has been closed. The clinical trial was first received in February 21, 2008, and was last updated on April 24, 2012.

The FDA is not required to call a meeting of its orthopedic committee to make a final decision on approving the device. The fact that the agency wants to meet with its expert panel indicates the staff has some clinical questions it wants the experts to consider.

Time and Place

The February meeting will be held from 8 a.m. to 6 p.m. at the Hilton Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy, Gaithersburg, Maryland.

The agency intends to make background material available to the public no later than two business days before the meeting. The material will be available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm. Scroll down to the appropriate advisory committee meeting link.