Following U.S. Food and Drug Administration (FDA) 510(k) clearance in March 2019, the first JAZZ Cap procedures have been successfully completed by fellowship trained orthopedic spine surgeon Chi Lim, M.D., in Spartanburg, S.C.
JAZZ Cap is a unique and complete proprietary solution for securing screws in poor quality bone—a factor in 10 percent to 30 percent of vertebral fusion cases in adult patients.2
Lim, of Carolina Orthopaedic & Neurosurgical Associates, said, “I have been using Implanet’s Jazz Band implants with excellent results in complex adult deformity indications. The arrival of JAZZ Cap as part of the Implanet band range is a major breakthrough in securing and protecting screws in poor quality bone. This new implant was easy to use during the first surgeries and has provided encouraging early post-operative clinical results. We will now follow these patients to confirm the long term outcomes. In my opinion, JAZZ Cap will quickly become an essential implant for spine surgeons.”
Ludovic Lastennet, Implanet’s CEO, commented: “I am excited to have personally attended Dr. Lim’s initial Jazz Cap procedures. The successful completion of these first surgeries represent a significant step for the development of our company, opening a unique opportunity in the U.S. degenerative spine market. We anticipate JAZZ Cap will become a significant alternative to cement augmented pedicle screws. Full market release of the technology is scheduled for September, with a global presentation at the North American Spine Society Annual Meeting in Chicago.”
Founded in 2007, Implanet is a medical technology company that manufactures implants for orthopedic surgery. Its flagship product, the Jazz latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Implanet’s orthopedic platform, which is based on perfect control over the traceability of its products, provides it with a proven ability to promote this innovation. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the FDA and the CE mark. Implanet employs 38 staff and recorded 2018 sales of 6.7 million euros. Based near Bordeaux in France, Implanet established a U.S. subsidiary in Boston in 2013. Implanet is listed on Euronext Growth market in Paris.
1 Sources: i-Data 2010; D. K. Chin et al. Osteoporos Int (2007) 18:1219–1224; Company; 2015 Health Advances study
2 Source: 2015 Health Advances study