Global medical technology leader Zimmer Biomet (NYSE and SIX: ZBH) and Canadian medical data startup Canary Medical received de novo clearance and market authorization from the US Food and Drug Administration (FDA) for a tibial extension for Persona IQ, the world’s first “smart” knee implant. The Persona IQ system is the first and only smart knee with FDA clearance for total knee replacement surgery.
The tibial device is based on Canary’s proprietary implantable canturio te tibial extension sensor technology and serves as an add-on to Zimmer’s personalized knee implant called Persona The Personalized Knee.
Combining Zimmer’s personalized, custom-crafted Persona knee implant with Canary’s canturio te technology allowed the two companies to craft the Persona IQ smart knee, which collects and evaluates gait measures to allow continuous monitoring of patients after surgical implantation of the device.
The Persona IQ’s intelligence comes from Canary’s canturio te gait-tracking sensor technology. The implantable Canturio TE sensor records gait metrics like range of motion, walking speed and step count and wirelessly transmits this information to Zimmer Biomet’s cloud-based data-tracking platform. Surgeons can access the data to monitor post-surgery recovery in real-time. This allows for better post-op evaluations compared to self-reported metrics to measure progress.
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Zimmer Biomet’s Persona line of personalized implants are designed to be customized to each patient’s anatomy. The Persona knee system features anatomically accurate implants that can be adjusted at fine increments of one mm to two mm, allowing for custom fitting of the implant into a patient’s original bone structures.
“Persona IQ reflects our shared belief that automatic, reliable and accurate data collection and analysis represents the future of orthopedic care,” said Dr. William Hunter, CEO of Canary Medical in a joint press release with Zimmer Biomet. “The launch of Persona IQ marks the start of an exciting, ongoing partnership with Zimmer Biomet designed to innovate smart implant technologies that help joint replacement patients regain and maintain their mobility with confidence.”
Persona IQ can be linked to other devices in Zimmer’s ZBEdge Connected Intelligence Suite platform, such as the mymobility with Apple Watch remote digital care management platform, which connects to iPhones and Apple Watches. The platform has clinical intelligence software that enables health care teams to track and analyze data over time. For example, data collected from sensors in the Persona IQ system can be analyzed to identify progress and long-term trends. The sensor-collected post-op data can be compared to pre-op gait metrics to evaluate progress.
The platform also contains educational modules, exercise tutorials and telehealth visits among other features that are delivered directly to patients through mymobility.
“Following a recent expansion of our partnership with Canary Medical, we now expect that Persona IQ will be the first in a broader portfolio of smart implant technologies in various orthopedic surgery applications,” said Bryan Hanson, chairman, president and CEO of Zimmer Biomet.
The FDA clearance of the Persona IQ system comes shortly after Zimmer Biomet snapped up 510(k) clearance for Rosa Hip, its robotic surgery system for direct anterior hip replacements. Rosa Hip is also hosted on the ZBEdge platform and is designed to collect data before, during and after a hip replacement procedure to evaluate progress in recovery.
“Persona IQ reflects our shared belief that automatic, reliable and accurate data collection and analysis represents the future of orthopedic care,” said Dr. Hunter. “The launch of Persona IQ marks the start of an exciting, ongoing partnership with Zimmer Biomet designed to innovate smart implant technologies that help joint replacement patients regain and maintain their mobility with confidence.”
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