Mulhouse, France-based FH Orthopedics developed the CP-ESP, an elastic spine prosthesis for cervical applications.
Here are six things to know:
1. The CP-ESP has received the CE Mark and is available in heights from 5mm to 7mm with three different footprints.
2. The company previously developed an elastic spine prosthesis for lumbar applications. The LP-ESP was one of the world's first monobloc lumbar disc replacements implanted and it received the CE Mark in 2004.
3. Using a minimally invasive anterior approach, the LP-ESP and CP-ESP aim to restore normal curvature and disc function for those suffering from degenerative disc disease. Additionally, the LP-ESP is indicated for lumbar discopathy that is resistant to medical treatment, lumbar discopathy disease after treatment of a herniated disc and radiculopathy by a recurrence of a disc hernia.
4. Neither the LP-ESP nor the CP-ESP are approved by the U.S. Food and Drug Administration as yet.
5. There has been a surge in devices intended to treat degenerative disc disease. Precision Spine recently received 510(k) clearance from the FDA and launched its VAULT-C Anterior Cervical Interbody Fusion Device. RTI Surgical also announced the full market launch of the Streamline OCT System earlier this year.
6. However, the cost-effectiveness of cervical degenerative disc disease is still under questions. A study published in Spine analyzed five studies on the topic and researchers found two studies showed cervical disc replacement might be more cost-effective than anterior cervical discectomy and fusion. Also, two studies comparing anterior and posterior surgical procedures for cervical spondylotic myelopathy show anterior surgery was more cost-effective.
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