POLARIS AR receives US Food and Drug Administration approval for STELLAR Knee

MIAMI, Nov. 3, 2023 /PRNewswire/ — POLARIS^AR is pleased to announce today that their STELLAR knee has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). STELLAR Knee is the first approval for POLARIS^ARa company focused on creating a new category in surgical guidance in Mixed Reality.

POLARIS^AR and STELLAR Knee are building the intersection of physical surgery and virtual surgical guidance, creating a unique digital operating room environment. This digital OR environment uses Mixed Reality displays to provide surgeons with real-time access to intraoperative anatomical data used to measure, plan and guide total knee arthroplasty procedures. Using a unique combination of proprietary optical tracking algorithms and spatial computing software, STELLAR Knee measures and records clinically meaningful hard and soft tissue anatomical data, enabling sub-millimetric intraoperative planning and providing precise resection accuracy and guidance.

“This is an important moment for orthopedic surgery,” said Dr. John Cooper, associate professor of orthopedic surgery, Columbia University Irving Medical Center. “Before STELLAR Knee, I had to rely on the inaccuracy of conventional instruments, or on complex technologies such as robotics to improve surgical precision. While these technologies provide important data that can be used to personalize surgery for each patient, they require a large footprint in my OR and a significant financial commitment from my institution. Now I can wear an unobtrusive digital assistant that provides real-time measurements and calculations I can trust, validating surgical decisions.”

With no footprint in the operating room other than a Mixed Reality headset that acts as a three-dimensional spatial computing tool, STELLAR Knee dynamically acquires patient-specific anatomical data and digitizes that information into holographic displays. By capturing the surgeon’s field of view, STELLAR Knee creates a real-time digital data exchange between the surgeon and the technology that supports clinical decisions. Surgeons have full interactive capabilities with the highly customizable and intuitive user interface, allowing them to make quick assessments and micro-adjustments to the surgical plan.

With minimal physical installation, a simple integration process and competitive pricing compared to traditional surgical guidance systems, STELLAR Knee has the ability to shift the standard of care. The STELLAR Knee workflow is open and available for use in all total knee replacement implant systems. POLARIS^AR and STELLAR Knee are creating a new category in surgical guidance software that leverages the latest visual display technology.

“One of the most important aspects of new technology entering the operating room is the impact it makes and the footprint it requires,” said Dr. Francis Gonzales, professor of orthopedic surgery, University of California, San Diego. “Technological progress does not always correlate with improvements within the OR. STELLAR Knee is an exception. Because it has no footprint outside the headset, no computers or stalls, it does exactly what it was designed to do: it allows me to focus on what matters most: the operation, and to have confidence in the decisions I make. take.”

“Our software has the power to usher in the next generation of surgical advancements,” said Paul Mikus, Chief Executive Officer of POLARIS^AR. “This is a new day for orthopedics and surgery as a whole, as the promise of Augmented Reality is now being fulfilled. STELLAR Knee is pioneering a new class of surgical software that leverages best-in-class spatial computing and optimizes operating room workflow. STELLAR Knee not only impacts the surgeon and the patient, but also empowers healthcare providers to change the standard of care.”

For more information about POLARIS, visit the link below^AR and STELLAR Knee, and to connect to a sales or POLARIS^AR team representative: https://www.thinkpolaris.com/

ABOUT POLARIS^AR

POLARIS^AR is a Miami-based startup whose mission is to develop a new class of Mixed Reality surgical technology. Their goal is to optimize intraoperative workflows and improve patient outcomes using advanced, three-dimensional spatial computing algorithms – going beyond traditional navigation, patient-specific instrumentation, robotics and first-generation augmented reality.

The US Food and Drug Administration has approved STELLAR Knee in 2023. The company was founded in 2020 and is headquartered in Miami, Florida.

For more information about POLARIS^ARvisit: https://www.thinkpolaris.com/

For any further information please contact:
Media
Ethan Metelenis
Ethan.Metelenis@precisionvh.com
917.882.9038

SOURCE PolarisAR