This study, co-authored by the Departments of Pediatric Orthopedic Surgery at the Robert Debré (Paris), La Timone (Marseille) and Purpan (Toulouse) hospitals in France, represents a key stage in the JAZZ system’s clinical validation and confirms both safety and efficacy in the treatment of hypokyphotic idiopathic scoliosis. The study followed a 35 patient consecutive series for an average of 34 months.
“These results confirm the efficacy of combining the posteromedial translation technique with rigid chrome-cobalt rods, enabling sagittal alignment to be restored in hypokyphotic patients suffering from idiopathic scoliosis”, said Prof. Brice Ilharreborde, M.D., Ph.D. “The use of JAZZ sublaminar bands should be considered for these patients to reduce complication rates and, in particular, the risk of intra-operative failure of the concave screws as a result of pulling from the bone. Furthermore, the reduced number of implants used to adequately treat these deformities allows the cost of surgery and the risk of medullary complication to be reduced.”
Ludovic Lastennet, CEO of Implanet, added: “The results of this major study confirm that the JAZZ implant offers surgeons a safe and efficient alternative to traditional techniques, with excellent clinical results documented an average of 34 months postoperatively, in patients suffering from complex hypokyphotic thoracic scoliosis.”
Although many surgeons still advocate using constructs consisting entirely of screws for this type of patient, the results of this study show that the JAZZ system should be a recommended front line treatment, in particular when treating hypokyphotic pathologies.
Founded in 2007, IMPLANET manufactures implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the U.S. Food and Drug Administration in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2015 sales of 6.7 million euros.
Based near Bordeaux in France, IMPLANET established a U.S. subsidiary in Boston, Mass., in 2013. IMPLANET is listed on Compartment C of the Euronext regulated market in Paris.