Monday, November 28, 2022

Naviswiss Receives FDA Clearance for Its Miniature Hip Navigation

Expanding Across Markets in the U.S.A.

June 18, 2020

Naviswiss AG, Denver, Colorado-based and with headquarters in Brugg, Switzerland, announced they received FDA Clearance on June 10, 2020, for their new navigation technology for hip replacement surgery.

Naviswiss adds the clearance includes primary hip replacement and revision hip replacement surgery used in a variety of surgical approaches and compatible with most implants on the market. 

The U.S. market estimates 498,000 Total Hip Replacements (THA) to be completed in 2020 with predictions of continued growth to 652,000 by 2025, as reported by The National Center for Biotechnology Information. Less than 20% of all THA’s currently use computer navigation for implant alignment.

The company provides miniaturized surgical navigation systems to aid orthopedic surgeons in accurately positioning acetabular implants. The navigated hip application is image-free and provides the surgeon with cup alignment, leg length, and offset. The hip application includes a single tray of surgical instruments and supports minimally invasive surgery from a variety of surgical approaches.

In late 2019, Naviswiss named Daniel Moore to head U.S. efforts as their Chief Commercial Officer and opened its U.S. Headquarters in Denver. Now with FDA clearance, they are offering their products in all U.S. Markets, looking to build upon their previous business in Europe, Australia, and Asia.

“The Naviswiss hand-held system is a simple, cost-effective solution for navigated hip replacements,” stated Dan Moore, Chief Commercial Officer. “There is a technology gap in hip replacements, largely due to the complexity and cost of previous technologies, and we have solved for it. Naviswiss can now offer a simple, imageless solution to patients and healthcare providers, with the potential of reducing the rate of revisions and radiation exposure.”

“We are extremely excited to be launching in the U.S. The Naviswiss system is unique in both form and function. We developed our core technology to be smaller, lighter, and more accurate than current solutions,” CEO Jan Stifter explained. “In turn, 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 significant investments from its customers. With their open platform, supporting all implant vendors, Naviswiss is currently signing up distributors in the U.S.

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