OEM News

Surgical Planning Associates Wins FDA Nod for HipInsight 2.0

The mixed-reality surgical guidance system now features a newly-patented way of overlaying digital content onto the patient.

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By: Sam Brusco

Associate Editor

Surgical Planning Associates (SPA) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new HipInsight 2.0 mixed-reality guidance system for hip replacement.
 
The system now features a newly-patented way of overlaying digital content onto the patient, which the company said makes the surgical workflow more wide-ranging, seamless, and applicable to any surgical technique. Typically, surgeons have to perform a 3D procedure based on 2D X-ray planning and, often, intraoperative assess the X-ray.
 
HipInsight puts 3D information onto mixed-reality display eyeglasses so surgeons can have more intuitive knowledge and don’t have to remove their eyes from the patient.
 
The new tech can also generate “future X-rays” to the show the desired surgical result. These can be shown on the mixed-reality device to project onto intraoperative X-rays so a live comparison can be seen mid-surgery.
 
The system can also rapidly assess leg length and hip width change.
 
“Every patient’s anatomy and hip arthritis is unique,” said Matt Miller, MD, of Stanford Orthopedic Surgery, who performs surgeries at El Camino Health, Los Gatos, Calif. “HipInsight allows a customized 3D model that helps a surgeon plan for and execute a more perfect reconstruction for each individual patient.”
 
SPA has an exclusive, multi-year, co-marketing agreement for HipInsight with Zimmer Biomet.
 
Zimmer Biomet’s marketing VP, Steve Vankoski, said, “Our companies have been able to work synergistically through our exclusive collaboration to successfully support clinical use of this fast evolving, transformative technology.”
 
The HipInsight system, according to SPA, is the only patient-specific mixed-reality system, now with enhanced features to support the essential steps of both primary and complex revision arthroplasty. HipInsight gives surgeons “x-ray vision” to see detailed sequential 3D information in and around the hip joint.

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