FDA clears J&J's robotic surgery system for total knee replacements

Johnson & Johnson’s DePuy Synthes division has received FDA clearance for its robotic-assisted orthopedic surgical platform for total knee replacements.

The Velys digital joint reconstruction system—also used for hip and shoulder procedures—is designed to work with the company’s Attune knee implant. Alongside advanced planning capabilities, the system helps the surgeon make precise cuts into bone and position the replacement joint accurately relative to the knee’s surrounding muscles, tendons and ligaments.

“Globally, previous generation robotics have only penetrated key orthopaedic segments between 5-10% of the market,” said Aldo Denti, group chairman of the DePuy Synthes franchise. “A significant opportunity for combined robotic and digital surgery technology exists.”

The Velys solution was designed from technology J&J acquired through its 2018 buyout of French developer Orthotaxy. The system mounts onto an operating room table and links to joint assessment data to help correctly balance the implant and verify its position.

RELATED: Johnson & Johnson to take over Verb Surgical, its robotics venture with Verily

DePuy previously partnered with Zebra Medical Vision to co-develop programs that create 3D joint models from 2D X-ray images to provide surgical planning without the need for a more expensive MRI or CT scan. 

Over time, J&J plans to integrate new technologies into the platform such as sensors, apps and patient selection tools, spanning orthopedic care from preop planning to postop rehabilitation.

“With the addition of the Velys Robotic Assisted Solution to our Velys Digital Surgery Platform, we are continuing our vision to be the most personalized and connected orthopaedics company,” Denti said. 

RELATED: Auris shows off data from first-in-human study of its robotic lung biopsy platform

Elsewhere in J&J’s medical device sphere, Ethicon and Auris Health published additional results from the Monarch lung bronchoscopy robot gathered from a first study in live human participants. 

The Monarch system uses an articulated tube to navigate the passages through the airway and the lungs to reach nodules suspected of harboring lung cancer. Guided using a video game controller, it delivers a biopsy needle and retrieves samples for analysis.

The BENEFIT trial was previously presented as a late-breaking study at the annual meeting of the American College of Chest Physicians in late 2019, demonstrating that it could reach target lung lesions in 52 of 54 patients. Pneumothorax occurred in two patients, with one case requiring the placement of a tube to drain air or fluid from the chest.

The latest publication—featured in the college’s official journal CHEST—included an exploratory analysis placing the study’s overall diagnostic yield at 74.1%. In addition, a yield of 70% was achieved in lung nodules located outside of the patient’s airway, compared to reported yields of 30% to 40% when using non-robotic technology.

“Physicians in the study, using our first-generation Monarch software, were able to localize and diagnose the most difficult-to-reach nodules at a higher rate than was previously possible,” said Eric Davidson, president of flexible robotics at Auris Health, which J&J acquired in 2019 for $5.8 billion. “Since then, we have continued to improve the platform, delivering a higher level of accuracy and ease of use.”

Auris is also evaluating the system’s safety and diagnostic yield through the TARGET clinical study, which plans to enroll a total of 1,200 participants across 30 sites and deliver results in 2024.