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Compliance In Focus
Posted by John Lehmann on Tue, May 28, 2019

How Robotic Surgery Is Transforming Orthopedics

Since the FDA approved the first robotic surgery system in 2000, robotic surgery has been extending its reach to a variety of specialty areas, including orthopedics.

robotic-surgery

Five of the world’s 10 largest orthopedic device companies have introduced or acquired robot-assisted surgical platforms within the past year. These systems show great promise to increase precision, reduce recovery time and reduce readmissions.

However, they also raise some important concerns.

Here’s a closer look at how robotic surgery is being used in orthopedics, its outcomes so far and the regulatory outlook.

Key Players In Robotic Surgery

The da Vinci Surgical System, manufactured by Intuitive Surgical, was the first robot-assisted surgery platform to earn FDA approval and was initially used for laparoscopic gallbladder and reflux disease surgery. Since then, it has been used in more than 6 million procedures, ranging from general surgery to cardiac, gynecology and urology surgeries.

Since then, a number of other medical device companies have developed robot-assisted surgery platforms. Here are five companies leading the way with advancements in the orthopedic industry.

1. Zimmer Biomet - Robotic-Assisted Knee and Spinal Surgery Platforms

Zimmer Biomet recently won FDA clearance for the ROSA ONE Spine, a surgical navigation system that helps surgeons perform minimally invasive and complex spine procedures. The system includes a workflow to help surgeons focus on patient outcomes and dynamic tracking functionality that allows it to move with the patient without needing to be attached to the patient or the table.

This system expands the functionality of robotic systems previously approved for brain and knee surgeries, making Zimmer the first company in the world to offer all three procedures on one platform. The ROSA knee platform includes 3D pre-operative planning tools and real-time data on tissue and bone anatomy during procedures, according to a news release. This can improve bone cut accuracy and result in a more precise range of motion analysis, which can help knee replacements feel more natural.

2. Medtronic - The Mazor X Stealth Robotic-Assisted Spinal Surgical Platform

Medtronic purchased Mazor Robotics and its robotic-assisted surgery platform for $1.7 billion at the end of 2018. The Mazor X Stealth won FDA clearance in November and is just beginning to launch in the United States.

The technology uses software to plan a spinal procedure, helping surgeons visualize everything down to the trajectory of each screw. During the surgery, a robotic arm guides implants and surgical instruments. Real-time imaging helps surgeons ensure the procedure is being carried out properly.

3. Smith & Nephew - Software for Its Hand-Held Robotic Surgical System

Known as a global leader in knee implants, Smith & Nephew already has a hand-held robotic surgical system on the market. It recently introduced new software for that system, known as the Navio 7.0. This software includes a new intuitive interface, expanded surgical preferences and a streamlined workflow, according to a news release. These updates, expected to be released later this year, will potentially reduce surgery time. Smith & Nephew is also working on a new, improved robotics platform that’s expected to incorporate augmented reality, stand-alone robotic arms and machine learning technologies.

4. Johnson & Johnson - Robotic-Assisted Surgery Platform in Development

Johnson & Johnson recently acquired Orthotaxy, a French robotic-assisted surgery company. It’s now working to expand that technology from total- and partial-knee replacements into other orthopedic surgeries, according to a recent Mass Device article.

The goal is to improve outcomes and add value by making orthopedic procedures more personalized to individual patients.

5. Stryker - Robot-Assisted Knee and Hip Surgery System

Stryker is already the world’s largest orthopedic device company, with $13.6 billion in revenue in 2018, according to Medical Design & Outsourcing.

This year, it expects double-digit percentage growth in its Mako systems for robot-assisted knee and hip surgery. The Mako robot-assisted system develops a 3D model of the joint, which surgeons use to evaluate bone structure, joint alignment and surrounding tissue. It provides real-time range-of-motion data during surgery and uses a robotic arm to remove the bone and cartilage from the knee and place the implant.

In lab and clinical trials, the Mako platform has been shown to:

  • Improve surgical precision
  • Protect soft tissue and ligaments
  • Reduce pain and improve patient satisfaction six months after surgery (compared to a conventional joint replacement)

Benefits of Robotic Surgery

Although robotic surgery is still relatively new for many applications, recent clinical data has demonstrated several benefits, including:

  • Improved accuracy of joint or screw placements
  • Reduced length of hospital stay due to the minimally invasive nature of surgeries (Nearly three days less on average, compared to open surgery)
  • Fewer revision surgeries and reduced readmissions
  • Significant cost savings (a conservative estimate of $608,546 per year for a center performing 557 thoracolumbar surgeries)
  • Shorter operating time (by an average of 3.4 minutes)
  • Reduced pain and scarring
  • Reduced radiation exposure
  • Lower infection rates 

While the initial capital investment of robotic surgery systems is significant (a single da Vinci Robot ranges from $1.5 to $2 million) the improved outcomes, cost savings and potential for greater patient volume can help to justify the cost.

Regulatory Concerns Related to Robotic Surgery

Robot-assisted surgery may not be appropriate for every application.

For instance, the FDA recently warned against using it for mastectomies and other cancer surgeries, citing safety risks that outweigh potential benefits.

Additionally, a 2016 review of all types of robotic surgery over a 14-year period found a number of adverse events reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE), including:

  • 144 deaths
  • 1,391 injuries
  • 8,061 device malfunctions, including burnt or broken pieces of instruments, electrical arcing and having to interrupt surgery to restart the system

There are also concerns that surgeons are not being properly trained to use robotic surgery systems. A recent documentary highlighted concerns about the use of the da Vinci Robot.

In the documentary, Intuitive Surgical’s attorney Richard Friedman told the FDA it planned to issue training requirements as part of the sale of the machine to hospitals. But shortly after the FDA gave permission to market, Intuitive scaled back all of the training requirements.

Several women interviewed in the film said they experienced pelvic organ prolapses after having routine hysterectomies with the da Vinci robot.

The FDA does not regulate the practice of medicine and therefore does not supervise or provide accreditation for physician training, nor does it oversee training and education related to legally marketed medical devices. Instead, training development and implementation is the responsibility of the manufacturer, physicians, and healthcare facilities.

Robotic surgery shows great promise to transform orthopedics and many other areas, contributing to better outcomes and potential cost-savings for hospitals. However, more clinical trials and post-market data collection are needed to ensure the benefits outweigh the risks.

The IMARC team has extensive experience overseeing clinical trials for orthopedic devices, and we’ll be keeping a close eye on robotic-assisted applications in the coming years.

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Topics: medical device trends

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