Coflex Interlaminar Stabilization Device (Paradigm Spine LLC) for treatment of lumbar spinal stenosis
HAYES, Inc.
Record ID 32016000955
English
Authors' recommendations:
Description of Technology: The coflex Interlaminar Stabilization device is a functionally dynamic, implantable, titanium interspinous process device (IPD) that is intended to limit lumbar spinal extension in order to maintain direct neurological decompression, unload the facet joints, and stabilize the motion segment at the treated vertebral level(s). The coflex is a U-shaped implant with 2 pairs of serrated wings extending from the upper and lower long arms of the U. The U portion is inserted horizontally between 2 adjacent spinous processes. The wings are crimped over bone to hold the implant in place. The device is implanted after decompression of stenosis at the affected level(s).
Patient Population: The coflex device is indicated for use in skeletally mature patients with 1- or 2-level lumbar spinal stenosis (LSS) from L1 to L5; at least moderate impairment in function; relief from leg, buttocks, or groin pain and symptoms when in flexion; and ≥ 6 months of nonoperative treatment. Back pain does not have to be present.
Clinical Alternatives: Conservative treatments for LSS include nonsteroidal anti-inflammatory drugs, analgesics, epidural steroid injections, physical therapy, exercise, bedrest, chiropractic manipulation, and acupuncture. Surgical options include laminectomy, laminotomy, foraminectomy, facetectomy, and discectomy, alone or followed by spinal fusion. A variety of IPDs are available on the market, including X-Stop Interspinous Process Decompression Device (Kyphon Inc.), the Wallis interspinous device (Abbott Spine), and the Diam Spinal Stabilization System (Medtronic Sofamor Danek).
Details
Project Status:
Completed
Year Published:
2016
URL for published report:
The report may be purchased from: http://www.hayesinc.com/hayes/crd/?crd=14987
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
United States
MeSH Terms
- Humans
- Back
- Spinal Stenosis
- Spine
Contact
Organisation Name:
HAYES, Inc.
Contact Address:
157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218
Contact Name:
saleinfo@hayesinc.com
Contact Email:
saleinfo@hayesinc.com
Copyright:
2014 Winifred S. Hayes, Inc
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.