Naviswiss Wins FDA Clearance for its Miniature Hip Navigation

Naviswiss AG, a medical technology company based in Brugg, Switzerland, has received U.S. Food and Drug Administration (FDA) clearance for its new navigation technology for hip replacement surgery. The clearance includes primary hip replacement and revision hip replacement surgery. The system can be used with a variety of surgical approaches and most implants on the market.
 
The U.S. market looks particularly good for Naviswiss with 498,000 total hip replacements forecasted by 2021. This is an increase of 34 percent and that growth will continue with 652,000 procedures predicted by 2025. While computer assisted total knee replacement (TKA) is quite common, most hips in the United States are still done using only mechanical alignment guides. In late 2019, Naviswiss named Daniel Moore to head U.S. efforts as chief commercial officer and opened its U.S. headquarters in the RINO neighborhood of Denver. With the recent FDA approval, Naviswiss is offering its products in all U.S. markets, looking to build upon its previous business in Europe, Australia, and Asia.
 
Moore commented, “There has been a need in the U.S. for a simple, cost-effective solution for navigated hip replacements. Where technology has been quite common in knee replacements in recent years, there has still been a technology gap in hip replacements. This is largely due to the complexity and cost of previous technologies. We can now offer a simple, imageless solution to patients and healthcare providers, with the potential of reducing the rate of revisions as well as reducing radiation exposure.”
 
The Naviswiss team has a deep history with orthopedic navigation, particularly with CEO Jan Stifter, who has been involved in computer assisted surgery for more than 20 years and held leadership positions with Smith+Nephew and Plus Orthopedics.
 
“We are extremely excited to provide our core products to the U.S. market. The Naviswiss system is unique in both form and function. Rather than using off-the-shelf tracking components like most other navigation systems, we developed our core technology to be smaller, lighter and more accurate,” Stifter explained. “In doing so we reduced the cost of a computer assisted hip and empowered surgeons to have more information about the specific patient anatomy.”
 
Naviswiss has implemented a “fee per use” business model, providing technology for a low per case cost, eliminating the need for large investments from its customers. With its “open platform,” supporting all implant vendors, Naviswiss is currently signing up distributors in support of U.S. interest