Centinel Spine announced on October 14, via a press release, U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for 2-level indications for the prodisc® C Vivo and prodisc® C SK cervical total disc replacement (TDR) devices. Since receiving FDA approval for 1-level indications in July 2022, nearly 20,000 prodisc C Vivo & prodisc C SK spinal levels have been implanted in the U.S. by over 1,100 surgeons.
- A landmark IDE Clinical Study successfully demonstrated the safety and clinical effectiveness of prodisc C Vivo & prodisc C SK, achieving the highest overall composite clinical success rate at two-levels as compared to any other approved cervical total disc replacement (TDR) device.1
- The prodisc C Vivo & prodisc C SK Match-the-Disc™ System has now become the first and only cervical TDR system with two different devices approved for both one- and two-level use.
- Centinel Spine's prodisc technology is now the only TDR solution in the U.S. approved for one- and two-level use in both the cervical and lumbar spine.
1 The Study Success Rate reported is based on the Overall Success rate of the Primary Analysis Population in the SSED for each cervical total disc replacement device with two level indications.
"What sets the prodisc C Vivo & prodisc C SK system apart is the ability to match the implant to the patient anatomy for a more tailored approach to the procedure. We are excited to see the release of the expanded indications for this system."
-Dr. Jad Khalil, Orthopedic Spine Surgeon with Michigan Orthopaedic Surgeons, Southfield, MI
"I am thrilled to witness the culmination of our efforts in the prodisc C Vivo & prodisc C SK clinical trial for two-level indications, resulting in FDA approval. I am particularly enthusiastic about integrating the distinct endplate configurations of the prodisc devices into my clinical practice."
-Dr. Armen Khachatryan, Orthopedic Spine Surgeon with Michigan Orthopaedic Surgeons, Southfield, MI
Centinel Spine’s CEO, Steve Murray, stated, “This is a historic milestone for Centinel Spine and further advances treatment options for spine surgeons and their patients. This 2-level approval advances the concept of uniquely matching the disc to each level of the patient’s cervical spine and is a major step forward in total disc replacement.”