Centers for Medicare and Medicaid Services allows for coverage of Prodisc-L at the discretion of local Medicare directors
Reimbursement coverage possible for qualified Medicare beneficiaries 60 and under
Solothurn/Switzerland, August 20, 2007
The Centers for Medicare and Medicaid Services (CMS) announced that it has reached a final decision to cover lumbar artificial disc replacement at the discretion of the local medical directors for Medicare beneficiaries ages 60 and younger. This decision means that certain patients who qualify for Medicare benefits will continue to have access to the Prodisc™-L for the treatment of degenerative disc disease.
“This decision has been expected and is important because it allows Prodisc-L to be a treatment option for the right patients who may benefit from its advanced motion-preserving technology,” said Michel Orsinger, President and Chief Executive Officer of Synthes. “By restoring motion and relieving pain, Prodisc-L provides physicians with a proven surgical therapy that can help patients suffering from degenerative disc disease return to an active lifestyle.”
In the U.S. Investigation Device Exemption (IDE) trials comparing Prodisc-L to spinal fusion, patients demonstrated range of motion that was improved or maintained, rapid pain relief, faster recovery, shorter hospital stay and more satisfaction with the Prodisc-L procedure.
Prodisc-L, which is composed of proven materials with more than a 20-year history of use in hip and knee replacements, has been implanted in more than 18,000 patients worldwide during the last 17 years. Prodisc-L, approved by the U.S. Food and Drug Administration (FDA) in August 2006, is the first and only FDA-approved spinal arthroplasty device to use a semi-constrained ball and socket design. This unique device allows a physiological range of motion and restores disc height.
Back pain is a leading cause for physician visits, with approximately 60-80 percent of the U.S. population experiencing acute low back pain at least once in their lives. While the majority of patients improve with conservative care, a small minority becomes chronically debilitated and require surgical intervention. The most common surgical procedure to treat disc degeneration disease is lumbar spinal fusion, with approximately 250,000 Americans undergoing the procedure annually. While lumbar spinal fusion can be effective in reducing pain, it affects range of motion and may cause stress to the adjacent discs.
Increasingly private payers are covering the costs for the surgical implementation of Prodisc L. Nationally, Aetna, Kaiser Permanente and CIGNA cover the procedure, as well as Blue Cross Blue Shield plans in AR, NJ and MT. Combined, these payers provide health insurance to nearly 38 million people. This decision by CMS offers further evidence that it is an appropriate treatment for the right patients suffering from degenerative disc disease and severe low back pain.
Orsinger said this decision will provide further support to other insurers regarding the importance of Prodisc-L artificial disc replacement as an important treatment option for patients with degenerative disc disease that have not responded to other treatment.
Synthes: A leading medical device company
Synthes is a leading global medical device company. We develop, produce and market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.
For further information please contact
Peter Fehlmann, Investor Relations, Synthes, Inc.
Phone: +41 32 720 48 10 , Fax: +41 32 720 48 11
e-mail: ir.info@synthes.com