Zimmer Biomet (NYSE:ZBH) and Canary Medical announced today that the FDA granted de novo classification for Persona IQ.
The de novo grant and marketing authorization comes for the tibial extension for Persona IQ, which the companies tout as the first and only smart knee implant cleared by the FDA for total knee replacement surgery. (Canary Medical CEO Dr. Bill Hunter described the highly anticipated technology to MassDevice and Medical Design & Outsourcing earlier this year.)
According to a news release, Persona IQ combines Zimmer Biomet’s Persona personalized knee implant with Canary Medical’s proprietary implantable Canturio TE (tibial extension) sensor technology designed to measure and determine a range of motion, step count, walking speed and other gait metrics.
Zimmer Biomet’s remote care management platform that includes MyMobility with Apple Watch and other components of the ZBEdge connected intelligence suite will work together with Persona IQ, which the companies will make available to healthcare providers in the coming months.
Once implanted in the knee, Persona IQ records and wirelessly transmits a wide range of gait data to a patient’s personal base station at home before data are then securely delivered to a cloud-based platform for surgeons to assess post-surgery recovery progress.
“We are excited to introduce Persona IQ, the world’s first and only smart knee implant, which offers a wealth of objective data to monitor patients’ post-operative progress,” Zimmer Biomet president & CEO Bryan Hanson said in the release. “As the newest component of ZBEdge, Persona IQ advances our vision of creating a seamlessly connected suite of digital health and robotic technologies to deliver objective data to clinicians throughout the surgical journey. 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.”
Canary’s Canturio TE, licensed by Zimmer Biomet through an exclusive partnership agreement, uses the same material and technology found in cardiac devices like pacemakers. The platform has a battery lifespan of up to 10 years, so patients do not need to charge the device, while it collects data passively so as to not rely on patient compliance.
“After almost a decade of development and designation by FDA as a breakthrough device, we’re proud that our Canary Canturio TE technology has enabled Zimmer Biomet to debut the world’s first smart knee implant. Persona IQ reflects our shared belief that automatic, reliable and accurate data collection and analysis represents the future of orthopedic care,” Canary Medical’s Hunter said. “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.”