The FDA 510k clearance and CE marking will allow the company to launch Jazz Frame across various markets. It is planned to be introduced in the first quarter of this year.
The implant is intended for the treatment of spinal pathologies needing vertebral fusion surgery. It is protected by four international patents for the
JAZZ Frame is a system of connectors, the last link in the JAZZ Band technological platform dedicated to the hybrid surgical technique.
Implanet CEO Ludovic Lastennet said: “We continue to strictly adhere to, and execute our business plan. The rapid marketing clearance in Europe and the United States is a real source of satisfaction, innovation that maximizes the clinical value of our technology.
“Optimized for implementation of the “frame” technique, we expect this implant to be rapidly adopted by our partner surgeons, pediatric and adult deformity specialists alike.”
Through the new implant, the company claims to give surgeons the possibility of working out and streamlining a worldwide strategy to bring down major deformities, thus making the most of long-term clinical outcomes.
Robert Debré Hospital APHP Professor Keyvan Mazda said: “Using the JAZZ Frame facilitates the restoration of both frontal and sagittal balance, thanks to the simultaneous reduction of both thoracic curves. This is most notable in the case of the most complex deformities where shoulder imbalance is common.”
Headquartered in Bordeaux, France, Implanet is a medical technology company with specialization in developing vertebral and knee-surgery implants.
