Naviswiss U.S. announced the first successful U.S. surgery with its hand-held hip navigation system following FDA 510(k) clearance in 2Q20.
Indicated for primary and revision hip replacement procedures, the system uses proprietary tracking technology with 95% smaller trackers to provide real-time measurements down to the degree for anteversion, inclination, leg length and offset. The open platform works with all major hip implants and approaches.
Naviswiss plans to expand usage in New York and throughout the U.S. in 2020 with a fee-per-use model rather than requiring a hospital or ASC to purchase the system. It is easily transported between O.R.s, supporting multiple procedures. The system also documents final implantation parameters that allow surgeons and patients to review the final surgical results.
Last month, the company announced completion of 1,000 navigated total hip replacement cases worldwide.