Zimmer Biomet Holdings, Inc. is the first out of the FDA gate with an August 30, 2021, announcement of the “world’s first and only” smart knee implant to receive FDA De Novo classification grant and authorization to market the Persona IQ, for total knee replacement surgery.
The “smart” comes from combining Zimmer Biomet’s Persona knee with Canary Medical’s proprietary implantable canturio™ te tibial extension sensor technology that, “monitors implant function to inform surgeons and patients of post-surgery progress.”
Implanted Sensors
Here’s how it works—the implants are fitted with a sensor that transmits information (wirelessly) to a cloud server through a base station in the patient’s home. Information such as range of motion, step count, walking speed, etc., is then aggregated and analyzed to give the patient and their surgeon a snapshot of recovery progress. The company says surgeons can assess post-surgery recovery progress by comparing pre-operative mobility metrics captured by mymobility®, with post-operative gait metrics collected by Persona IQ.
Typically, surgeons have had to rely on patients to report on their progress during infrequent in-person follow-up visits.
CEO Hanson: Hip and Shoulder Coming
Zimmer Biomet thinks it’s such a big deal that the FDA clearance of Persona IQ was announced by its Chairman, President and CEO Bryan Hanson. He said this newest component of ZBEdge advances the company’s vision of “creating a seamlessly connected suite of digital health and robotic technologies to deliver objective data to clinicians throughout the surgical journey. Following a 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.”
Hanson announced the relationship with British Columbia-based Canary Medical, creator the Canary Health Implantable Reporting Processor (CHIRP) inside the Persona-IQ, during the company’s 2021 first quarter earnings call with analysts. “I can tell you that they’re (surgeons) interested in being able to capture data from inside the body. And this is unique, they’ve not been able to do this before.”
“It’s going to be for hip, it’s going to be for shoulder, there’s going to be a whole pipeline of technologies that will launch.”
Peter Sculco, M.D., orthopedic surgeon at Hospital for Special Surgery in New York, said smart implants like Persona IQ, can “actively monitor patient recovery and rely on real-world, objective data to supplement patient care. 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.”
William Hunter, M.D., MSC and CEO of Canary Medical said the Persona IQ, “represents the future of orthopedic care.”
Wall Street: “Next Major Breakthrough in Orthopedics”
Some on Wall Street agree. This past January we wrote about Stryker Corporation’s acquisition of Florida-based OrthoSensor, Inc., a developer of “intelligent” implants and devices. At the time, Larry Biegelsen and his team of analysts at Wells Fargo wrote that the Stryker acquisition “validates our call that smart implants represent the next major breakthrough in orthopedics.”
On August 30, 2021, Biegelsen wrote Persona IQ is “the world’s first smart orthopedic implant and we believe that its clearance reflects a watershed moment in medical devices.”
Biegelsen noted that Stryker, with the OrthoSensor acquisition and Johnson & Johnson have shown their intention to participate in this space. He wrote that Johnson & Johnson has told Wells Fargo that it has spent the last three years developing smart sensor/implant capability in-house with first applications in trauma.
But Zimmer Biomet is the first out of the FDA gate.
Ortho “Pacemaker”
The company announcement says the Canary canturio te uses the same material and technology found in implanted cardiac devices such as pacemakers. Patients don’t have to charge the device as the sensor battery has a 10-year lifespan.
Furthermore, the company says because the technology is implanted, data is collected passively and does not rely on daily patient compliance.
It’s worth noting that this announcement came one day before Zimmer Biomet announced four data presentations on mymobility with Apple Watch. The technology touts a remote care management platform to help healthcare professionals support and guide patients during their preparation for and recovery from orthopedic procedures. So now, if someone asks how your knee replacement is doing, you look at your watch.
Indications
According to the company, “the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient’s total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment post-surgery.”
“The device is indicated for use in patients undergoing a cemented TKA procedure that are [sic] normally indicated for at least a 58 mm sized tibial stem extension.”
“The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.”
The company says Persona IQ will be available to healthcare professionals and patients in the coming months.
