Robotic surgery has many uses, but FDA is concerned about training

Issue: May 2019

Click here to read our Cover Story, Robotics open the door for high-risk kidney transplants

The special use of robotic surgery by Enrico Benedetti, MD, for performing kidney transplants is one example of how these instruments are used in health care. Many specialties, including orthopedics, obstetrics/gynecology and oncology are using the devices to perform minimally invasive surgical procedures. According to the website Analytics Insight, the following are the seven largest manufacturers of robotics for medical applications:

1. Intuitive Surgical — Analytics Insight calls Intuitive Surgical the “global leader” in robotic-assisted surgery, well known for its Da Vinci Surgical System. The robotic system has been the subject of more than 7,000 peer-reviewed publications and studies and is used worldwide.

2. Hansen Medical — The Silicon Valley-based company focuses on medical robot systems for cardiac and vascular surgeries and sells the Magellan and Sensei X robotics system.

3. Medrobotics — The company has launched the Flex Robotics System to aid surgeons in their operations, with a focus on accessing anatomical locations that were previously difficult or impossible to reach.

4. Verb Surgical — Manufacturer is focused on building a digital surgery platform using artificial intelligence and data analytics.

5. Microbot Medical — Micro-robotics medical technologies are this company’s forte, along with a specialization in research, design and development of new technologies for surgeries.

6. Titan Medical — The company is developing the SPORT Surgical systems to cover abdominal, gynecological and urologic areas.

7. CyberKnife System — This company offers a fully robotic radiation delivery system to treat cancerous and non-cancerous tumors.

Several hundred papers have been published on the value of robotics in the medical arena since the first robotic surgery in 1985; The Journal of Robotics Surgery recently listed the 100 most-cited manuscripts, most of which featured urological surgery.

“The 100 most-cited manuscripts reflect the progression of robotic surgery from a basic instrument-holding platform to today’s articulated instruments with 3-D technology. From feasibility studies to multicenter trials, this analysis demonstrates how robotic-assisted surgery has gained acceptance in urological, colorectal, general, cardiothoracic, orthopedic, maxillofacial [surgeries] and neurosurgery,” the authors wrote. According to the NIH’s Cancer Institute, almost 80% of prostate removal surgeries in the United States are now being done with robotic equipment. Other conditions seeing a rise in successful robotic surgeries include lung diseases, upper- and middle-back (thoracic) conditions, hysterectomies and bariatric surgeries to treat obesity.

The industry is not without controversy. In February, the FDA released a safety communication about using robotically assisted surgery for performing mastectomies and other cancer-related surgeries.

“ ... It is important for health care providers and patients to understand that the safety and effectiveness of using robotically assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established,” the FDA wrote in the safety alert. “There is limited, preliminary evidence that the use of robotically assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival ... the FDA encourages health care providers who use robotically assisted surgical devices to have specialized training and practice in their use.” – by Mark E. Neumann

References:
Connelly TM, et al. J Robot Surg. 2019; doi:10.1007/s11701-019-00956-9.
www.analyticsinsight.net/top-7-healthcare-robotics-companies/
www.fda.gov/medicaldevices/safety/alertsandnotices/ucm632142.htm
www.healthnewsreview.org