CE mark and FDA clearance for Implanet’s new JAZZ diameters

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Implanet has obtained regulatory clearance from the US FDA (Food and Drug Administration) to market its 3.5mm, 4mm, 4.5mm and 6mm JAZZ rods in the USA and the CE mark in Europe, adding to the original 5.5mm diameter clearance.

This clearance addresses the treatment of adolescent scoliosis, the first clinical indication targeted by Implanet, as well as treatment of deformity and degenerative spinal disorders in adults. Combined with the CE mark obtained in April 2015, these clearances “allow JAZZ to now be a true technological platform – JAZZ Band”, says a company press release.

Ludovic Lastennet, chief executive officer of Implanet, says: “The implantation of more than 6,000 JAZZ devices in a single 5.5mm diameter version since its launch in late 2013 is an impressive achievement for the company.” He continues, “Our proprietary single-screw design provides optimal tensioning of the band, ensuring robust fixation, controlled by a simple and highly-efficient tensioning instrument. Multiple papers published in 2015 substantiate JAZZ’s clinical efficacy in the treatment of scoliosis, while an independent medico-economic study published in March confirmed the economic benefit of hybrid constructs consisting of screws and sublaminar implants. This economic advantage, combined with a comprehensive range of JAZZ implants, will enable us to achieve our objectives in a global environment where healthcare expenses are subject to more and more stringent controls.”

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