The US Food and Drug Administration (FDA) has awarded a De Novo classification grant and authorisation to Zimmer Biomet and Canary Medical to market the tibial extension for Persona IQ for total knee replacement surgery.
The first-ever smart knee in the world to receive FDA clearance, Persona IQ merges Zimmer’s established knee implant, Persona The Personalized Knee, with Canary’s implantable canturio te tibial extension sensor technology.
The canturio te technology can assess and determine range of motion, step count and walking speed, as well as various other gait metrics.
Furthermore, Persona IQ will work with various other components from Zimmer’s ZBEdge Connected Intelligence Suite, including the mymobility with Apple Watch remote care management platform.
Once surgically positioned in the knee, Persona IQ records and wirelessly sends a broad range of gait data to the personal base station at the patient’s home.
The data is sent to a Cloud-based platform, where surgeons can monitor post-surgery recovery progress by analysing pre-operative mobility metrics, obtained by mymobility, with post-operative gait metrics captured by Persona IQ.
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Furthermore, the data from Persona IQ will be seamlessly merged with pre-, intra- and post-operative data obtained by the ZBEdge Connected Intelligence Suite and evaluated by the OrthoIntel Orthopedic Intelligence Platform to offer objective data to surgeons as an add on to patient care.
Canary Medical CEO William Hunter said: “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.
“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.”
Zimmer licensed the CANARY canturio te technology in an exclusive collaboration agreement with Canary Medical for the creation of smart orthopaedic implants to remotely monitor and track patient recovery metrics.
Last December, Zimmer Biomet acquired Vance Street Capital portfolio company A&E Medical, which manufactures sternal closure devices, for a total of $250m.