Healthcare Industry News: FDA
News Release - August 13, 2024
Surgical Planning Associates Receives FDA Clearance for New HipInsight System(R) 2.0 Mixed-Reality System for Hip Arthroplasty
BOSTON, Aug. 13, 2024 -- (Healthcare Sales & Marketing Network) -- Surgical Planning Associates (SPA) today announced it has received FDA 510(k) clearance for the new HipInsight® 2.0 mixed-reality guidance system for hip arthroplasty.The HipInsight system is the only patient-specific mixed-reality system, now with enhanced features to support the essential steps of both primary and complex revision arthroplasty. The HipInsight system gives surgeons "x-ray vision" to see detailed sequential three-dimensional information in and around the patient's hip joint.
The system now enables a newly patented method of overlaying the powerful digital content onto the patient making workflow more wide-ranging, seamless, and applicable to any surgical technique. Traditionally, surgeons must perform a three-dimensional procedure based on two-dimensional X-ray planning and often intraoperative X-ray assessment. The HipInsight system puts three-dimensional information onto mixed-reality display eyeglass lenses so surgeons have more intuitive knowledge and don't have to take their eyes off of the patient.
If surgeons do want to use X-rays in surgery, the new technology also has the capability of generating "future X-rays" in advance that show the desired surgical result. These future X-rays can be displayed on the mixed-reality device to project onto actual intraoperative X-rays so that the surgeon can see a live comparison during surgery. The system also has new capability for rapid assessment of leg length and hip width change.
"Every patient's anatomy and hip arthritis is unique," said Matt Miller, M.D., 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."
Dr. Kevin Park of Houston Methodist added, "HipInsight System 2.0 advances the already amazing capabilities of the original system. The new functionality supports the surgeon for even the most complex primary and revision surgery challenges that we encounter."
ZimmerBiomet's Marketing Vice President, Steve Vankoski, noted, "Our companies have been able to work synergistically through our exclusive collaboration to successfully support clinical use of this fast evolving, transformative technology."
About Surgical Planning Associates
Surgical Planning Associates, Inc. (SPA) is an ISO 13485:2016 certified medical technology company that specializes in the development of innovative, cost-effective preoperative planning and navigation solutions for use in joint arthroplasty. A pioneer in the fields of surgical planning and computer-assisted joint reconstruction, SPA is privately held and based in Boston.
About the Zimmer Biomet Relationship
Surgical Planning Associates and Zimmer Biomet Holdings have an exclusive, multi-year co-marketing agreement for the HipInsight System.
For more information about HipInsight System®, visit www.hipinsight.com
Source: Surgical Planning Associates
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