Implanet a medical technology company focused on vertebral and knee implants, has begun a prospective and multicenter clinical study, designed to document the outcomes of the JAZZ Band in adult degenerative and adult deformity indications. As indicated in the March 14, 2016 news release, “Implanet has partnered with TFS International, a professional CRO (Contract Research Organization), to help ensure a scientifically robust study design and execution.”
IMPLANET Commences Multicenter Study
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“In addition to the partnership with TFS International, Implanet is finalizing agreements with eminent U.S. spine centers with strong expertise in complex adult degenerative surgery and a deep interest in developing innovative spinal implant technology platforms.”
Implanet CEO Ludovic Lastennet stated, “We are pleased to announce this important first step in the establishment of our prospective multicenter U.S. study, partnering with a highly reputable CRO to initiate and manage the project with the highest standards of quality and rigor. The JAZZ Band has tremendous potential as a tool for surgeons to augment spinal fusion in complex adult surgery. As the global leader in band based technologies, we are excited to take a leadership position in both rapidly expanding our product portfolio and documenting clinical and economic outcomes.”
Daniel Spasic, CEO of TFS International, added, “We are very pleased with Implanet’s decision to partner with TFS on this multicenter U.S. study. TFS will now, together with some of the most renowned medical centers in the country, work diligently to ensure the execution of a successful study and help to position Implanet as an innovator in complex spine surgeries.”
Lastennet told OTW, “Implanet is THE band company, offering the widest band range in the market, from 3.5mm up to 6.35mm, with development initiatives focused solely on expanding band based technologies in both the adult and pediatric markets.”
Asked about potential challenges, he stated, “Our challenge is to expose the market to the role the JAZZ Band can play in a variety of complex spinal fusion cases. Investing in multi-center, prospective clinical work is an important component of this process.”
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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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