U.S. Food and Drug Administration kept busy approving surgical robots from various market competitors

Davis, Mountain View, Santa Barbara 17 October 2001Computer Motion has received regulatory clearance granted by the Food and Drug Administration (FDA) for the SOCRATES Robotic Telecollaboration System. In reviewing SOCRATES, the FDA created a new classification of medical devices, titled "Robotic Telemedicine Device". SOCRATES is the first and only device in this classification to be approved by the FDA for clinical use. The FDA already recently cleared the da Vinci Ultrasonic Shears for use within Intuitive Surgical's current endoscopic indications, including urological, general, thoracic, and gynecological surgery. In turn, Integrated Surgical Systems plans to seek FDA clearance to market the ROBODOC System in the United States. ROBODOC has been applied to perform more than 9000 joint replacement procedures in Europe and Japan.

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Computer Motion expects the SOCRATES system to be used in co-ordination with the company's system of products to create exciting new training and mentoring opportunities for surgeons in a wide variety of disciplines. Dr. Peter Schulam, chief of the Division of Endourology and Laparoscopic Surgery in the Department of Urology at the University of California Los Angeles (UCLA) Medical Center commented: "Inadequate mentoring following educational courses has dampened the dissemination of laparoscopic surgery. Socrates may greatly impact surgical training and education by providing global access to specialists. Tele-surgical mentoring may be both cost and time effective for the surgeon."

Dr. Schulam continued: "The potential benefits to the patient include expanded availability to novel surgical procedures and decreased likelihood of complications. Socrates will offer support to surgeons during the learning curve of new procedures, thereby providing a safer environment to the patients during this transition." SOCRATES allows a surgeon at a remote location to connect to an operating room and share video and audio, use a telestrator to annotate anatomy or surgical directions, as well as to control HERMES networked devices, like the AESOP-HR endoscopic camera positioner. Surgeons can share diagnostic and treatment recommendations, indicate best practices techniques for specific cases, and collaborate effectively.

Yulun Wang, Ph.D., founder and chief technical officer of Computer Motion, said: "Our commitment to advancing the adoption of less-invasive surgical procedures necessarily requires providing effective training solutions. SOCRATES is the first of many initiatives in telemedicine the company intends to pursue. In the future, we envision extended networks connecting mentors and training surgeons at facilities around the world." The company plays a crucial role in transitioning the surgical community from current open procedures to increasingly demanded endoscopic procedures.

Computer Motion's competitor Intuitive Surgical Inc. has made available the da Vinci Ultrasonic Shears. The product was featured at the recent American College of Surgeons Conference in New Orleans. The Ultrasonic Shears is a result of the collaboration between Intuitive Surgical Inc. and Olympus Optical Company Ltd. This instrument is the medical industry's first robotic, fully integrated ultrasonic device, which allows surgeons to perform cutting and coagulation applications.

"We could not be more delighted with the output of our first co-development initiative with Olympus Optical. The da Vinci Ultrasonic Shears will immediately expand the da Vinci system's clinical capabilities, most significantly in the field of General Surgery, while reducing costs for our customers. It represents the progress that can be made when two industry partners focus on one surgical solution", stated Lonnie Smith, President and CEO of Intuitive Surgical Inc. "The endoscopic surgical equipment manufacturers are both targeting minimally invasive surgery in the future. We are optimal partners to promote advanced robotic endoscopic surgery. The latest results of the co-development project have brought the realisation of patient-friendly 21st century endoscopic surgery one step closer", added Sumio Gotoh, head of Surgical Business Unit, Olympus Optical Company Ltd., Tokyo.

The instrument is designed to be multi-use and is powered by the Olympus SonoSurg generator. This provides surgeons using the da Vinci System with the added control of both coagulation and cutting. Dr. Santiago Horgan, Director of Minimally Invasive Surgery at the University of Illinois at Chicago, stated: "There is no question in my mind that the da Vinci Ultrasonic Shears provides significant clinical capability and control during both routine and advanced surgical procedures. In the advanced procedures where I have used it, it has enhanced the procedure tremendously."

As the third expert in image-directed, semi-autonomous robotic products for surgical applications, Integrated Surgical Systems Inc. successfully completed the first ROBODOC Surgical Assistant System hip replacement surgery at its second clinical trial site, the University of Arkansas Medical Sciences. The United States clinical trials, which require a total of 188 subjects at three sites, began in December 2000.

Since that time, 35 successful procedures have been performed at Sutter General Hospital in Sacramento, California. While the company hoped that clinical trials at the University of Arkansas would begin in early 2001, the Internal Review Board (IRB) approval process took longer than anticipated. The addition of the third clinical trial site is also dependent upon IRB approval, but the company hopes that all clinical trial surgeries can be completed by mid-2002.

At the conclusion of the clinical trials, the company will seek FDA clearance to market the ROBODOC System in the United States. The ROBODOC Surgical Assistant System is a robotic system designed for both hip and knee replacement surgery. NeuroMate, the company's neurosurgery system, is the first robotic technology based system for use in stereotactic brain surgery.

For more news and details on the latest achievements of the three surgical robot competitors, you can consult the following VMW articles:


Leslie Versweyveld

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