Centinel Spine®, LLC, (“the Company”) the leading global medical device company addressing cervical and lumbar spinal disease with the most clinically-proven total disc replacement (TDR) technology platform in the world (prodisc ®), today announced that more than 250,000 prodisc devices have been implanted worldwide.* The prodisc lumbar and cervical technologies will be highlighted by Centinel Spine at the upcoming 2023 annual EUROSPINE meeting and congress in Frankfurt, Germany (October 4-6, 2023). The prodisc technology portfolio now includes four cervical and two lumbar devices—5 approved by the FDA—and has been validated with a reported reoperation rate of less than 1%.**
French orthopedic spine surgeon Thierry Marnay, MD invented the first-generation prodisc lumbar technology as a motion-sparing alternative to interbody fusion and, in 1990, implanted the first prodisc device at the Clinique du Parc in Montpellier, France.
Speaking to this achievement, Dr. Marnay stated, “We are so pleased that after 35 years of dedicated work that 250,000 implantations with the prodisc technology have occurred. This milestone suggests that total disc replacement has successfully passed the minefields of the ‘experimental’ phase and proceeded into ‘gold standard’ territory. The quality and durability of the cervical and lumbar prodisc technology has been confirmed through time, studies, and publications. We are proud that the disc arthroplasty revolution has changed the lives of so many patients and we are thankful to all surgeons who contributed to its success.”
Dr. Jack Zigler, orthopedic surgeon with the Center for Disc Replacement, Texas Back Institute, Plano, Texas, played a key role in the IDE clinical trial of the prodisc lumbar technology as the Principal Investigator and, in 2001, became the first surgeon to perform a prodisc TDR surgery in the U.S. In 2006, the next generation prodisc L Lumbar Total Disc Replacement device was approved by the FDA for single-level use. Then, in 2020, Centinel Spine announced FDA approval of two-level indications for the prodisc L system—making it the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine.
According to Dr. Zigler, “It is awesome to consider that over 250,000 prodisc cervical and lumbar devices have been implanted since their earliest use. Thanks to the innovative foresight of the primary technology inventor, Dr. Thierry Marnay, and the teams of dedicated people who advanced the clinical use of prodisc over the past 30 years, we now have the broadest base of scientific evidence ever developed for any implant that we place in the human body. The prodisc technology has changed the lives of thousands of patients globally, and it has been the highlight of my career as a clinician and researcher to have had the opportunity to participate in the evolution and acceptance of artificial disc technology.”
The prodisc C cervical TDR technology was later co-developed by Dr. Marnay and spine surgeon Prof. Dr. Rudolph Bertagnoli, Chairman/CEO of Pro-Spine, Straubing, Germany. First implanted in Europe in 2002, the cervical prodisc design paralleled the lumbar design, incorporating prodisc CORE technology—the unique kinematic design of all prodisc implants, engineered to provide stability and controlled predictable motion.
On this occasion, Prof. Dr. Rudolf Bertagnoli reflects, “In the past 25 years, I have personally implanted over 10,000 prodisc implants since co-inventing the technology with Dr. Marnay. In my hands, for treating degenerative disc disease, this has become the gold standard and my preferred method. When fusing patients, I am taking away their body’s natural function—but by replacing their discs with mobile devices, I am giving them their function and, therefore, their life back. The prodisc technology has not only changed the way we treat degenerative disc disease, but it has also given thousands of people the chance to live life fully again.”
“The Centinel Spine team is inspired by the clear benefit the prodisc family of total disc replacements has had on patients around the world,” concluded Centinel Spine CEO Steve Murray. “While much has been accomplished thus far in the prodisc journey, we look forward to continued and accelerated innovation, reach, and impact with prodisc .”
Most recently, in Q4 2022, Centinel Spine launched the prodisc C Vivo and prodisc C SK system in the U.S., the only cervical TDR system that allows matching the disc to the needs of the patient and surgeon.
* Data on file.
** Based upon U.S. complaint handling units for prodisc since launch in 2006
