Implanet Gets CE Mark and FDA OK for Expanded Line of Spinal Rods

Implanet, a French medical technology company specializing in vertebral and knee-surgery implants, today reports receiving U.S. Food and Drug Administration clearance to market its 3.5, 4, 4.5, and 6 millimeter (mm) Jazz rods, adding to the original 5.5 mm diameter clearance.

The company also reported receiving CE mark in Europe for the same implants.

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.

“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,” said Ludovic Lastennet, CEO of Implanet. “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.”

Based near Bordeaux, France, Implanet established a U.S. subsidiary in Boston, Mass., in 2013. The company employs 45 staff and recorded 2014 sales of 7.0 million euro (approximately $8.5 million).