INTEGRATED SURGICAL SYSTEMS GRANTED FDA CLEARANCE FOR FRAMELESS TECHNOLOGY FOR THE NEUROMATE SYSTEM
News July 2, 08:00 Eastern Time
DAVIS, Calif., Jul 2, 1999 /PRNewswire via COMTEX/ -- Integrated Surgical Systems, Inc. (ISS) (Nasdaq: RDOC; EASDAQ), a pioneer in medical robotics and the world leader in image-directed, semi-autonomous robotic products for surgical applications, announces it has gained US FDA Clearance to use its proprietary frameless technology with the NeuroMate(TM) System.
The NeuroMate(TM) System, ISS' neurosurgery system, is the first robotic technology for use in stereotactic brain surgery. It consists of a robotic arm assembly and a PC-based positioning system. This system's operating software and open architecture interfaces to most popular planning stations.
Currently, stereotactic procedures are routinely performed using antiquated frame and arc devices developed at the turn of the century. These frames are extremely painful, limit surgeon's access to the patients brainand takes more expensive operating room time.
Comparing ISS' frameless technology with the current frame system, Professor Alim Benabid, world renowned Neurosurgeon at the University of Grenoble stated, "Our ability to offer an equally accurate, but a less invasive solution that not only increases patient comfort but reduces the operating room time, is a significant advantage over currently accepted techniques. This results in a truly win-win situation for the hospital, patient andsurgeon."
The frameless system was extensively tested at the University of Grenoble in France, as well as the Rothschild Foundation in Paris and the Walton Center in Liverpool, England.
"We invested heavily to develop this proprietary technology, much likethe DigiMatch Pinless technology for orthopedic surgery. The introduction of the frameless application module represents a major step forward in further advancing robotics technology to the neurosurgery field," said Dr. Ramesh Trivedi, President and CEO of Integrated Surgical Systems, Inc. "We know that it will be positively received by neurosurgeons through out the world."
ISS has currently installed 11 NeuroMate systems worldwide, including U.S., France and Japan, which have supported neurosurgical procedures onmore than 1,800 patients, to date.
The Company Integrated Surgical Systems, Inc. develops, manufactures, markets and services computer-controlled, image-directed robotic products for surgical applications. ISS also produces the ROBODOC(R) Surgical Assistant System (ROBODOC), which is designed for orthopedic applications. The ROBODOC System has been used to perform precise total hip replacement surgeries on morethan 4,700 patients worldwide. ROBODOC is currently being marketed in Europe, Asia and the Middle East.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including the timely development and market acceptance of new products and upgrades to existing products, the impact of competitive products and pricing, and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission (SEC).
Note: ROBODOC(R) is registered trademark of Integrated Surgical Systems, Inc. NeuroMate(TM) is a trademark of Integrated Surgical Systems, S.A.
SOURCE Integrated Surgical Systems, Inc.
(C) 1999 PR Newswire. All rights reserved.
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CONTACT: Ramesh C. Trivedi, Ph.D., President & CEO, Mark Winn,
Chief
Financial Officer, of Integrated Surgical Systems,
530-792-2600; or general
information, Tracy McCarty, analysts, Kate Rajeck, or
media, Scott Marx, all
of the Financial Relations Board, 415-986-1591
(RDOC)
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