#SFHS2616325AFrance Adds PRODISC-C VIVO Cervical Disc Prosthesis to Reimbursement List
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This order adds the PRODISC-C VIVO cervical disc prosthesis from Centinel Spine to France’s reimbursable medical products list. It means the device can be covered under the social security reimbursement system when used for eligible adult patients with chronic, disabling cervical radiculopathy or myelopathy linked to degenerative cervical discs between C3 and C7. Hospitals, spine surgeons, and purchasing teams can now factor this device into reimbursed treatment pathways, but only within the listed indications and safeguards. The order also sets clinical limits, contraindications, surgeon training expectations, patient information duties, and post-surgery follow-up requirements.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Adds PRODISC-C VIVO cervical disc prosthesis to France’s reimbursable medical products list under code 3165747.
- Limits reimbursement to specified adult patients with chronic disabling cervical radiculopathy or myelopathy linked to degenerative discs between C3 and C7.
- Sets use conditions, including contraindications, trained surgical teams, patient information, and regular post-operative monitoring.
Obligations
What this law requires
Use the PRODISC-C VIVO cervical disc prosthesis for reimbursed care only in adult patients with chronic disabling radiculopathy and/or myelopathy linked to one or two mobile degenerative cervical discs between C3 and C7 that have resisted well-conducted conservative treatment for at least 6 months.
Do not use the PRODISC-C VIVO cervical disc prosthesis in patients with the listed contraindications: fractures, infections, tumors, spinal canal stenosis resulting from hypertrophic spondylosis, severe facet joint degeneration, increased segmental instability, or ossification of the posterior longitudinal ligament.
During the postoperative phase, physicians must properly inform the patient in addition to prescribing or supervising mobilization and muscle exercises.
After implantation, the cervical disc prosthesis must be checked periodically using appropriate techniques to detect early factors that could promote implant dysfunction, including loosening, dislocation, migration, or other serious complications.
The surgeon and surgical team must be familiar with the operative technique and with the range of implants and instruments to be used before performing the procedure.