Toronto-based SDRI, Inc. says it has a new cervical disc with “revolutionary” geometry which will be distributed in Germany, Austria and Switzerland by Joimax GmbH.
Synergy Claims Its Cervical Disc Is World’s First
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The five-year exclusive distribution deal for SDRI’s Synergy disc was announced by SDRI on December 12, 2014.
Uniqueness Claim
The company claims its disc is the first and only artificial cervical disc to unite the needs for sagittal balance and motion, making it the only viable alternative to fusion in patients with pre-operative spine alignment issues. Company officials claim their implant is the world’s first cervical disc replacement that is designed specifically to “actively correct pre-operative deformity, prevent post-operative misalignment and provide optimal stability for multi-level procedures.” The company says the device incorporates a “revolutionary” geometry which offers multiple alignment corrections to give surgeons precise control of lordosis and sagittal balance.
Kemal Yucesoy, M.D., a neurosurgeon involved in a 2009 European pilot study of the device said, “The gold standard (cervical fusion) involves proper reconstruction of sagittal balance following decompression. Conventional disc replacements, however, do just the opposite; they restore range of motion but they have an unpredictable impact on sagittal balance. The Synergy Disc combines the best of both of these very successful treatments by restoring range of motion and normal sagittal balance to the patient. Restoring alignment of the spine is vital for long-term success of cervical disc replacements. Our long-term follow-up has demonstrated outstanding results.” He added that the disc will help to expand the indications for cervical arthroplasty.
The results of European pilot studies of the implant have recently been submitted for publication.
Devesh Menawat, SDRI’s CEO, said “We are very excited with the initial results from Germany, which have validated our pilot cases. We are eagerly anticipating the next follow-up periods and engaging in the next steps of our strategy designed to gain regulatory approval for our [disc] in the U.S.”
Joimax’s Founder, CEO and President Wolfgang Ries said patients suffering from alignment problems have no viable option today. “We have begun to commercialize the product in Germany and early feedback from surgeons is very positive.”
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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