IMPLANET (Paris: IMPL) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has obtained regulatory clearance from the FDA (Food and Drug Administration) to market its 3.5 mm, 4.0 mm, 4.5 mm and 6 mm JAZZ rods in the United States and the CE mark in Europe, adding to the original 5.5 mm diameter clearance.
A significant milestone in Implanet’s development strategy, this 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. Combined with the CE mark obtained in late April 2015, these clearances allow JAZZ to now be a true technological platform – JAZZ Band® – comprising the most comprehensive range of sublaminar implants on the market, providing surgeons rod diameter flexibility depending on the disorder being treated.
Ludovic Lastennet, CEO of Implanet, says: “The implantation of more than 6,000 JAZZ devices in a single 5.5 mm diameter version since its launch in late 2013 is an impressive achievement for the Company. Reaching this latest regulatory milestone will enable us to better serve our customers with a comprehensive product range and to accelerate our deployment, not only in the United States but across all global markets. 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.” 