Abstract
PROBLEM
Since the COVID-19 pandemic of 2020, there has been a marked rise in the use of telemedicine to evaluate patients following total knee arthroplasty (TKA). Telemedicine is helpful to maintain patient contact, but it cannot provide objective functional TKA data. External monitoring devices can be used, but in the past have had mixed results due to patient compliance and data continuity, particularly for monitoring over numerous years. This novel stem is a translational product with an embedded sensor that can remotely monitor patient activity following TKA
SOLUTION
The Canturio™ TE∗ System (Canary Medical) functions structurally as a tibial extension for the Persona® cemented tibial plate (Zimmer Biomet). The stem is instrumented with internal motion sensors (3-D accelerometer and gyroscope) and telemetry that collects and transmits kinematic data. Raw data is converted by analytics into clinically relevant gait metrics using a proprietary algorithm. The Canturio™ TE∗ will monitor the patient's gait daily for the first year and then with lower frequency thereafter to conserve battery power enabling the potential for 20 years of longitudinal data collection and analysis. A base station in the OR activates the device and links the stem and data to the patient. A base station in the patient's home collects and uploads data to the Cloud Based Canary Data Management Platform (Canary Medical). The Canary Cloud is structured as an FDA regulated and HIPPA-compliant database with cybersecurity protocols integrated into the architecture. A third base station is an accessory used in the health care professional's office to perform an on-demand gait analysis of a patient. A dashboard allows the health care professional and patient to monitor objective data of the patient's activity and progress post treatment.
MARKET
The early target market for this device includes total joint surgeons who are early adopters of technology and currently utilize technology in their practice. The kinematic data provided by the Canturio™ TE∗ System will enable clinicians to augment patient care by reviewing their objective gait metrics. In the future, this data has the potential to be integrated with other Zimmer Biomet technologies, such as the Rosa™ Knee robotic platform, mymobility™, and sensored devices like iAssist™, to provide the surgeon with a complete pre-surgical functional assessment, intraoperative data, and post-operative functional data
PRODUCT
Persona IQ will be the combination of the proven Persona personalized total knee system with the Canary Medical Canturio™ TE∗.
TIMING AND FUNDING
The Canturio™ TE is currently under De Novo FDA review for market clearance; it is not yet available for commercial distribution. The plan is to launch the product in 2021 pending regulatory De Novo grant. This effort is a partnership between Zimmer Biomet and Canary Medical.
∗ The Canturio™ - TE is currently under De Novo FDA review for market clearance; it is not yet available for commercial distribution.
