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Home/Spine/Implanet: CE Mark for JAZZ Band Passer
Spine

Implanet: CE Mark for JAZZ Band Passer

November 6, 2017 1 min read Premium comments

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Implanet: CE Mark for JAZZ Band Passer
JAZZ Band Passer / Courtesy of Implanet
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Let the European marketing begin…spine and knee company Implanet, based near Bordeaux, France, has announced the receipt of CE regulatory clearance to market the new JAZZ Passer, a product devoted to posterior fixation in spine surgery.

Ludovic Lastennet, CEO of Implanet, said in the October 19, 2017 news release. “This innovation will accelerate the adoption of JAZZ technology by new European surgeons. This highly dynamic market is driven by France and Germany, regions where we are active, notably in the high potential adult degenerative bone disorder segment. At the recent Eurospine conference in Dublin, we saw enthusiasm for our solution from health professionals and surgeons. We were able to show, during a thematic evening with more than 50 participants and throughout this conference, how easy to use our latest innovations are.”

Lastennet told OTW, “JAZZ Band Passer is a brand new product designed by our research and development team that had to pass all regulatory steps. Like all new orthopaedic implants, JAZZ Band Passer from Implanet was submitted both for FDA 510(k) approval and CE Marking at the same time. We received the 510(k) approval from FDA end of September and the CE Marking in mid-October.”

“JAZZ Band passer is composed of a new JAZZ Band specially designed to be used with our new range of JAZZ Passers. This new product has been designed on surgeons request, to ease the surgical gesture and provide to surgeons an instruments to pass the Band around the anatomy of the patient. We believe that this new design will help the conversion of new surgeons to our technology.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

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?

8
JT
James Thornton, MDSpine Fellow · HSS

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.

5
RP
R. PatelSports Medicine · Stanford

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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