FDA Clears ARVIS Augmented Reality System

Insight Medical Systems has gained 510(k) clearance from the U.S. Food and Drug Administration for its flagship product, ARVIS (Augmented Reality Visualization and Information System). This is the first wearable surgical navigation system to be cleared for both hip and knee arthroplasty. ARVIS combines tracking cameras with both a 3D display and handsfree interface in an integrated eyepiece for total joint arthroplasty. Unlike other augmented reality (AR) platforms, ARVIS is the first system with proprietary hardware designed to assist arthroplasty surgeons in enhancing component positioning precision to improve joint arthroplasty outcomes.
 
“Developing our own hardware allowed us to make a system that’s optimized for arthroplasty surgeons and to avoid the compromises that come with adapting off the shelf augmented reality glasses,” said Jonathan Nielsen, vice president of R&D at Insight.
 
“This is an important milestone for Insight. We are excited to move forward with commercializing ARVIS with our partner DJO and to bring the benefits of augmented reality to hip and knee surgeons without the typical cost and complexity,” Insight CEO Nick van der Walt said.
 
In March, DJO announced a strategic investment in Insight Medical Systems to support its commitment to the growing computer-assisted surgery market. ARVIS complements DJO’s ASC 360 solutions and adds to its full range of implant solutions, surgical tools, and digital care solutions that uniquely span the continuum of care, well positioning DJO as a leader in the rapidly expanding ASC setting.
 
“DJO has been partnering with the orthopaedic surgeon community to understand their technology needs across all anatomies and in all settings in which they operate,” said Louis Vogt, president and general manager of DJO Surgical. “The Insight team has developed an impressive 3D AR technology that tracks the surgeon’s viewpoint and delivers navigation and patient-specific information right at the surgical site in a highly efficient and seamless workflow. ARVIS complements DJO’s ASC 360 solutions and adds to our full range of implant technologies, surgical tools and digital care solutions that uniquely span the continuum of care.”
 
For ease of use, the ARVIS system is compatible with existing surgical helmets, and a single tray of trackable instruments eliminates the need for disposables. Insight leveraged DJO’s sales channel and launched ARVIS in the second half of this year. The EMPOWR Partial, Primary and Complex Primary Knee and Hip implant systems are compatible. The EMPOWR portfolio is the culmination of research, clinical legacy and material technologies that have resulted in hip and knee products that help restore healthy kinematics and provide surgical efficiencies optimized for today’s health care environment. Driven by premium, intelligently designed single-tray instrumentation, these implant systems have up to a 50 percent reduction in storage and sterilization costs compared to similar products on the market.¹ 
 
Reference 
¹ Based on calculation of no. of trays compared to DePuy Pinnacle and Zimmer Biomet G7. https://www.ajog.org/article/S0002-9378(16)30358-1/pdf for cost of sterilization https://www.corailpinnacle.net/sites/default/files/2018-10/DSEMJRC05181044%20PINNACLE%20Surgical%20Technique.pdf https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/hip/2336.2-GLBL-en_G7%20Surgical%20Technique.pdf
Based on calculation of no. of trays compared to Oxford Uni Knee.
https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/knee/oxford-partial-knee-microplasty-instrumentation-surgical-technique.pdf