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Implanet receives FDA clearance and CE mark for new Jazz rods

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Implanet, a medical technology company specializing in vertebral and knee-surgery implants, recently announced it has obtained regulatory clearance from the FDA, as well as the CE mark in Europe, to market its 3.5-mm, 4-mm, 4.5-mm and 6-mm Jazz rods in the United States, adding to the original 5.5-mm diameter clearance obtained in late April, according to a company release.

The clearance addresses the treatment of adolescent scoliosis, the first clinical indication targeted by the company, but also the treatment of deformity and degenerative spinal disorders in adults.

“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, and an independent medico-economic study published in March confirmed the economic benefit of hybrid constructs consisting of screws and sublaminar implants,” Ludovic Lastennet, CEO of Implanet, said in the press release.
Reference: www.implanet.com.