PDATED 2/22/16: FDA's panel has voted against approval for the device. See additional information below on the panel's impressions.
On 2/19/16, FDA's Orthopaedic and Rehabilitation Devices Panel will meet regarding the PMA for Medtronic's DIAM™ Spinal Stabilization System. Specifically, the panel will discuss the device's clinical trial.
DIAM, an interspinous process technology, is indicated to treat low back pain under certain conditions (e.g. secondary to moderate lumbar degenerative disc disease at a single level from L2-L5, etc.), and is implanted via a minimally invasive posterior approach. DIAM stands for Device for Intervertebral Assisted Motion.
Medtronic launched DIAM in Europe in 2003, and in 2006, FDA granted IDE approval to begin a pivotal U.S. clinical trial of the device.
The Agency seeks the panel's input on interpretation of pivotal clinical study data in several areas, including:
- Study population
- Nonoperative control group and nonoperative therapies
- Study endpoint and timepoint for assessment
- Role of the DIAM as a primary treatment versus adjunctive therapy with direct spinal decompression
- Radiographic outcomes
- The way in which the data was collected and analyzed
UPDATE, 2/22/16: According to Healio.com, the 11-member FDA panel voted against recommending approval for the device, in light of questions about the clinical data used to back the PMA application. For example, one animal model showed a possible negative reaction to the foreign body of the implant. Further, while the trial data demonstrated device safety at 12-month follow-up, it is felt that more data are needed to show the implant’s long-term safety and efficacy. Source: Healio.com
Published at ORTHOWORLD