Implanet, a Bordeaux, France-based medical technology company with a U.S. subsidiary in Boston, Massachusetts, has announced COFEPRIS regulatory approval of its spinal products and a distribution contract with Novovascular Technologies in Mexico.
Implanet Signs Mexico Distribution Agreement
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Secondary#implanet#COFEPRIS#novovasculartechnologies
COFEPRIS is the federal commission for protection against sanitary risk. It is a regulatory body of Mexico’s government dealing with medical devices.
COFEPRIS has approved Implanet’s JAZZ® spine product range. The JAZZ® implant is “intended to improve the treatment of spinal disorders requiring spinal fusion surgery.”
A global company, Implanet distributes its products in over 15 countries. The partnership with Novovascular Technologies enables Implanet to offer its spinal products in Mexico.
Implanet CEO Ludovic Lastennet spoke extensively about the distribution partnership. “The signing of this new distribution partnership, following the approval of our products by COFEPRIS, finally allows us to be present in Mexico, the largest market in Central America. Mexico has historical ties to the sublaminar fixation technique used by our JAZZ® platform.”
Lastennet continued, “The approval of our products in this geographical region thus represents a significant breakthrough and allows Implanet to expand its global distribution network, in keeping with its commercial and regulatory strategy.”
Based in Monterrey, Nuevo León, Mexico, Novovascular Technologies offers “innovative products” to health professionals. Per the agreement, Novovascular Technologies will have the commercial rights to JAZZ® spinal products in Mexico.
Novovascular Technologies General Manager Sergio Rangel commented, “Adding the JAZZ® platform to our range of products is perfectly in line with our strategy that aims to provide surgeons and their patients with innovative products recognized for their clinical value on a global level.”
Rangel continued, “We are delighted with this partnership with Implanet and look forward to starting marketing its products in early 2021.”
For OTW’s recent coverage of Implanet, see “Implanet Receives Extended CE Mark for Knee System” and “Implanet to Sell Madison Total Knee Implant.”
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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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