Buffalo General Hospital/Kaleida Health becomes third site for FDA mandated clinical trials with ROBODOC

Davis 03 December 2002Integrated Surgical Systems Inc. (ISS), a pioneer in medical robotics and specialised in image-directed, semi-autonomous robotic products for surgical applications, has reached an agreement with Buffalo General Hospital/Kaleida Health and Dr. Kenneth Krackow for their participation as the third clinical site in the United States Food and Drug Administration (FDA) mandated Total Hip Arthroplasty (THA) procedure for the ROBODOC System.

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Commenting on this agreement, Ramesh Trivedi, President and CEO of ISS, stated: "This is a very important step in our plan to complete the clinical trials as thoroughly and as rapidly as possible. To date, a total of 89 patients have either already undergone the surgeries or are waiting to be operated as a part of the current clinical studies. With other clinical sites on the West Coast, in the Southwest, we were looking for a highly reputable site on the East Coast."

"Dr. Krackow's familiarity with the ROBODOC system goes back several years. He played a key role in helping ISS develop the Total Knee Arthroplasty (TKA) procedure for the ROBODOC system, which has been commercially available outside of the USA since 2000. His reputation as the premier orthopaedic surgeon throughout the world, combined with his keen interest in the robotics technology, made him the ideal choice. We are very honoured that Dr. Krackow has agreed to participate in this study."

"Ever since I collaborated with ISS in advising and guiding them through the development of the ROBODOC TKA procedure, I have been very intrigued and impressed with the robotics technology and its potential in the orthopaedic surgeries. Participation in the clinical trials seemed like an excellent way to further involve myself, my staff, and the institution with this technology", commented Dr. Krackow.

Integrated Surgical Systems designs, manufactures, sells, and services image- directed, computer-controlled robotic products for use in orthopaedic and neurosurgical procedures. The ROBODOC Surgical Assistant System is a robotic system for hip and knee replacement surgery. NeuroMate, the neurosurgery system, is the first robotic technology-based system for use in stereotactic brain surgery. More news on ROBODOC is available in the VMW May 2002 article Computer Motion and Integrated Surgical Systems take initiative for stronger market integration of surgery robots.


Leslie Versweyveld

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