Zimmer Biomet, Canary Medical Win FDA De Novo For First Smart Knee Implant
NEWS PROVIDED BY Medtech Insight, Marion Webb
Zimmer Biomet and Canary Medical’s FDA de novo clearance of the Persona IQ total knee implant intensifies Zimmer Biomet’s focus on data collection and analytics across continuum of care to improve outcomes and surgery methods, an analyst wrote.
Zimmer Biomet Holdings, Inc. and its partner Canary Medical announced on 30 August that the US Food and Drug Administration cleared a de novo application for their Persona IQ implant, the first implantable smart device for total knee replacement that uses sensor-based technology to provide real-world post-surgical patient data for the care team and patients.
“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,” said Bryan Hanson, Zimmer Biomet’s CEO. “Following our 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.”
“Following our 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.” – Bryan Hanson
The news comes one day before the kick-off of the biggest annual meeting of the orthopedic community, the American Academy of Orthopedics Surgery conference held from 31 August to 4 September at the San Diego Convention Center in downtown San Diego.
Wells Fargo analyst Larry Biegelsen in his analyst note from today called the FDA clearance a “watershed moment for orthopedics.”
“Persona IQ is the world’s first smart orthopedic implant and we believe that its clearance reflects a watershed moment in medical devices,” Biegelsen wrote. “We would expect smart implant technology to be broadly adopted by players in the orthopedic space, but noted that Zimmer Biomet has an important first-mover advantage with Persona IQ.”
“Persona IQ is the world’s first smart orthopedic implant and we believe that its clearance reflects a watershed moment in medical devices. We would expect smart implant technology to be broadly adopted by players in the orthopedic space.” – Larry Biegelsen
Stryker Corporation and Johnson & Johnson (Pty) Ltd, which market the Mako and Velys robotic-assisted solutions, respectively, plan to participate in this space as well. Stryker acquired OrthoSensor, Inc. in January of this year and Johnson & Johnson told Wells Fargo “they spent the last three years developing smart sensor/implant capability in-house with first applications in trauma,” Biegelsen said.
In an interview with Medtech Insight, Sharrolyn Josse, worldwide president of Velys Digital Surgery and Capital at J&J’s DePuy Synthes unit, also stressed the company’s investment in digital technologies includes robotics as well as aggregating data to track trends and provide insights to surgeons. The Velys received FDA clearance for implanting the Attune knee system this January and the company is rolling it out now. (Also see “Exec Chat: J&J DePuy Synthes’ Sharrolyn Josse Outlines Strategy For VELYS Digital Surgery” – Medtech Insight, 12 Jul, 2021.)
In a 30 August note, SVB Leerink analyst Richard Newitter called the Persona IQ clearance an “exciting new product advancement and potential source of differentiation for the company’s evolving knee franchise/digital surgery platform.”
In this final part of a three-part series on the “Future of Surgery” we highlight perspectives of a highly skilled orthopedic robotic surgeon on where we are today in robotic surgery and where we are going, introduce innovative surgical robotics companies, and discuss medtechs’ rising role in robotic surgery.
“There is intensifying interest/emphasis on data collection and analytics across the continuum of care in orthopedics broadly (pre-op, intra-op and post-op) in order to improve outcomes and surgery methods,” Newitter explained. “Sensor-based technologies appear to be at the forefront of this mission and Zimmer Biomet/Canary Medical will be the first implantable smart device (for total knee replacement) to hit the US market … putting Zimmer Biomet ahead of the curve or near-to-intermediate term in this emerging new technology area and it increases our confidence in Zimmer Biomet’s potential to re-accelerate US knee growth into the quarters/years ahead.”
Persona IQ combines Zimmer Biomet’s Persona knee system with Canary Medical’s proprietary implantable canturio te tibial extensor sensor technology that records and wirelessly transmits post-operative gait metrics, such as steps taking and walking speed, to patient’s personal base station at home. The data can be accessed by surgeons via the Cloud.
Persona IQ works with Zimmer Biomet’s remote monitoring platform, which includes the mymobility app with Apple Watch and other parts of the ZBEdge Connected Intelligence Suite. The sensor is powered by a battery that lasts up to 10 years, so patients don’t need to charge the device.
The implant passively collect data and does “not rely on daily patient compliance to ensure information is captured by Persona IQ,” Newitter pointed out.
Surgeons can assess the post-surgery recovery process by comparing pre-operative mobility metrics captured by mymobility with post-operative gait metrics collected by Persona IQ, the companies said. Ultimately, the data from Persona IQ will be seamlessly integrated with pre-, intra- and post-operative data collected by the Intelligence Suite to provide surgeons with objective data as a supplement to patient care.
Newitter does not expect Persona IQ to be a likely meaningful revenue contributor before 2022, but said it has significant revenue contribution potential in 2022 and beyond through recurring incremental remote implant monitoring revenue sources and potentially enhanced implant power pricing.
“Our understanding is that Persona IQ data qualifies as a remote patient monitoring service, which is CMS (Centers for Medicare and Medicaid Services)-compliant and has established reimbursement,” Newitter wrote, adding that this would allow clients to collect additional reimbursement when using Persona IQ both through remote monitoring codes.”
Zimmer Biomet may also be able to collect ad-on payment for the implant sensor itself.
The real value will be in the “outcome prediction capabilities,” such as identifying undetectable items like infection and implant loosening before they occur, which will require more data and additional regulatory approvals, he noted.
He expects the smart implant will be available to health care professionals and patients in the coming months following a “very gradual rollout.”