30 Day Trial
BARE BONES logo

BARE BONES content is posted to these pages in real time.

Monthly compilations are available in PDF form.

Reimbursement / Regulatory

FDA Panel Convenes to Discuss Medtronic's DIAM Spinal Stabilization System -

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

 

Sources: Advisory Committee Panel Meeting Announcement, Meeting Materials; ClinicalTrials.gov

 

This article is a Member-only item of content. Members, please log in to read the complete post.
If you are not yet a Member, click here to learn more about purchasing ORTHOWORLD Membership.