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FDA Clears Zimmer Biomet's Smart Knee Implant

Image courtesy of Zimmer Biomet Persona IQ smart knee implant
The Persona IQ implant was recently identified by MD+DI as one of the most anticipated new medical devices expected to hit the market by the end of the year.

The lines between traditional medtech and digital healthcare continue to blur, and a perfect example of this trend is Zimmer Biomet's Persona IQ smart knee implant, which is now FDA cleared. According to the company, the device is considered the first "smart" knee implant on the market for total knee replacement surgery.

The device was also recently identified by MD+DI as one of the 10 Most Anticipated New Medical Devices expected to reach the U.S. market by the end of the year.

Warsaw, IN-based Zimmer Biomet partnered with Vancouver, British Columbia-based Canary Medical, a medical data company, on the technology. The Persona IQ combines Zimmer Biomet's Persona knee implant  with Canary Medical's implantable canturio te tibial extension sensor technology that measures and determines range of motion, step count, walking speed, and other gait metrics. Persona IQ will work together with Zimmer Biomet's remote care management platform, my mobility with Apple Watch, as well as other components of the company's ZBEdge Connected Intelligence Suite.

Bryan Hanson, chairman, president, and CEO of Zimmer Biomet, said that as the newest component of ZBEdge, the Persona IQ smart knee implant 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 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. Persona IQ reflects our shared belief that automatic, reliable and accurate data collection and analysis represents the future of orthopedic care," said Canary Medical CEO William L. Hunter, MD. "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."

Peter Sculco, MD, an orthopedic surgeon at Hospital for Special Surgery in New York, explained that historically, surgeons have relied on patient-reported metrics during intermittent post-op visits to assess the quality and pace of recovery from knee replacement surgery.

"Now, with physiological tools to support remote monitoring technologies like mymobility, and smart implants like Persona IQ, we can actively monitor patient recovery and rely on real-world, objective data to supplement patient care," Sculco said. "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."

Once surgically implanted in the knee, Persona IQ records and wirelessly transmits a wide range of gait data to a patient's personal base station at home. The data are then securely delivered to a cloud-based platform. 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. Ultimately, the data from Persona IQ will be seamlessly integrated with pre-, intra- and post-operative data collected by the ZBEdge Connected Intelligence Suite and analyzed by OrthoIntel Orthopedic Intelligence Platform to provide surgeons with objective data as a supplement to patient care.

As the first smart knee implant on the market, prospective patients might have questions about the biocompatibility of the sensor in their new knee, and if it needs to be charged. The company noted that the sensor developed by Canary uses the same material and technology found in implanted cardiac devices such as pacemakers. The sensor is powered by a battery with a lifespan of up to 10 years, so patients will not need to charge the device. In addition, as an implanted technology, data is collected passively and does not rely on daily patient compliance to ensure information is captured by Persona IQ, the company said.

Zimmer Biomet plans to roll out the Persona IQ to the market in the coming months.

 

 

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