, /PRNewswire/ -- Simplify Medical, Inc. is pioneering disc arthroplasty with the non-metal, MRI compatible Simplify Disc, a cervical artificial disc. The Company announced today that it received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate its two-level clinical trial comparing Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control. This approval allows the expansion of Simplify Medical's clinical operations.
Simplify Cervical Disc
The Simplify Disc is a cervical artificial disc composed of MRI compatible materials utilizing advanced polymers and ceramic, designed to eliminate the need for radiation-intensive CT/Myelograms. The PEEK-on-ceramic articulation is designed for low levels of wear to optimize long-term durability, and Simplify Disc offers low height implant options for patients with smaller cervical disc spaces for whom larger implants are not optimal.
About the Artificial Disc Market
The Journal of Orthopaedic Sports Physical Therapy (2008;38(9):A1-A34) reports that 22-70% of the population will have neck pain at some point in their lives with chronic neck pain of greater than 6 months duration affecting 14% of individuals with neck pain. Neck pain is second only to low back pain in annual workers' compensation costs in the U.S.
About Simplify Medical
Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative MRI friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in . To learn more, visit our website at www.simplifymedical.com.