Dive Brief:
- FDA on Monday granted De Novo marketing authorization to Zimmer Biomet and Canary Medical's "smart knee" implant for total knee replacement. The device, called Persona IQ, combines Zimmer's Persona knee with Canary's implantable sensor technology to measure a patient's range of motion, step count, walking speed and other metrics.
- Zimmer CEO Bryan Hanson touted the development as the first product in a broader portfolio of smart implants combining digital health and robotic technologies that the orthopaedics device leader plans to offer through an expanded partnership agreement with data analytics-focused Canary.
- SVB Leerink analysts, in a note to clients Monday, called the new product an exciting advancement and potential source of differentiation that should help Zimmer re-accelerate U.S. knee growth into the years ahead. However, they said Persona IQ won't likely be a meaningful revenue contributor before 2022.
Dive Insight:
Zimmer and its longtime rival Stryker are racing to develop smart implant technologies for orthopaedics applications that will collect data with the aim of informing patient care and recovery.
Stryker earlier this year bought OrthoSensor, which makes sensors for use in total joint replacement procedures. Zimmer and Stryker executives both have said the data gathered through implant technologies eventually could be used to help predict surgical outcomes.
Zimmer's Hanson has told analysts that more than 70% of the company's innovation money is now invested in the areas of data informatics and robotics, in a big shift for the device maker. Zimmer has seen quick adoption of its Rosa robotic system, while Stryker has become a leader in the orthopaedic robotic market with its Mako system, which can be used for total and partial knee replacements and total hip replacements.
Persona IQ, Zimmer's smart knee, will collect data to monitor patients' post-operative progress, the company said. Zimmer is licensing the FDA breakthrough device-designated Canary technology for the implant.
Whereas orthopaedic surgeons have traditionally relied on patient information obtained in follow-up visits to assess the quality and pace of knee replacement surgery, the new technology will allow remote monitoring and give doctors objective data to aid in the patient's recovery.
Persona IQ will work with Zimmer's remote care management platform, mymobility with Apple Watch, and other components of the ZBEdge Connected Intelligence Suite.
The device records and wirelessly transmits the data to a patient's personal base station at home. The information is then delivered to a cloud-based platform where surgeons can assess progress and compare it to the patient's pre-operative mobility metrics.
"In addition, providing patients with access to their own mobility data will allow them the opportunity to be engaged in their recovery in a new way," Peter Sculco, orthopaedic surgeon at Hospital for Special Surgery in New York, said in Zimmer's press release.
SVB Leerink analysts said interest in use of data collection and analytics in orthopaedic procedures is increasing as a way of improving outcomes as well as surgical methods. "Sensor-based technologies appear to be at the forefront of this mission, and ZBH/Canary will be the first implantable smart device for total knee replacement to hit the U.S. market," the analysts wrote.
While the analysts expect the device to be available in the third or fourth quarter, they noted that Persona IQ won't likely be a meaningful revenue contributor before 2022. Looking forward, the analysts contend other orthopaedic surgery and joint replacement applications for the smart implant technology could include hip, trauma and extremities.
The De Novo authorization is Zimmer's third new product nod this year. The company gained 510(k) clearances for partial knee replacement and total hip replacement procedures for its Rosa robotics system earlier this year.
