Zimmer Biomet and Canary Medical have secured de novo classification grant and authorisation from the US Food and Drug Administration (FDA) for the Persona IQ smart knee implant.
The approval has been granted for tibial extension of the Persona IQ to facilitate total knee replacement surgery.
Persona IQ integrates Zimmer Biomet’s Persona knee implant with Canary Medical’s canturio te tibial extension sensor technology, which measures and determines range of motion, step count, walking speed and other gait metrics.
The smart implant is designed to work together with Zimmer Biomet’s remote care management platform called mymobility with Apple Watch and other components of the ZBEdge Connected Intelligence Suite.
Canary Medical CEO William 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.”
Upon the surgical implantation in the knee, Persona IQ begins to record and wirelessly transmit a range of gait data to a patient’s personal base station at home. Later, the data will be securely delivered to a cloud-based platform.
Surgeons will have the flexibility to evaluate post-surgery recovery progress by comparing pre-operative mobility metrics captured by mymobility with post-operative gait metrics collected by Persona IQ.
To provide surgeons with objective data to offer enhanced patient care, the data from Persona IQ is incorporated with pre-, intra- and post-operative data collected by the ZBEdge Connected Intelligence Suite and analysed by OrthoIntel Orthopedic Intelligence Platform.
Zimmer Biomet chairman, president and CEO Bryan Hanson said: “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.”
The canturio te tibial extension sensor technology was licenced by Zimmer Biomet via an exclusive partnership agreement with Canary Medical for the development of smart orthopaedic implants to facilitate remote monitoring and tracking of patient recovery metrics.
Recently, Zimmer Biomet secured FDA 510(k) clearance for the ROSA Hip System for robotically-assisted direct anterior total hip replacement.
