Integrated Surgical Systems Announces First Successful DigiMatch (Pinless) HipSurgery in the USA
DAVIS, Calif., Dec. 19 /PRNewswire/ -- Integrated Surgical Systems, Inc. (ISS) (Nasdaq: RDOC), a pioneer in medical robotics and the world leader in image-directed, semi-autonomous robotic products for surgical applications, announced that the first successful DigiMatch (Pinless) Total Hip Replacement (THR) surgery with its ROBODOC(R) Surgical Assistant System (ROBODOC) was performed today.
(Photo: newscom.com )
The surgery was performed by William Bargar M.D. at Sutter General Hospital in Sacramento, California. "Based on my experience as the principal investigator in the clinical studies for the pinbased system, this new DigiMatch (Pinless) Procedure appears to be simple but equally accurate. Not having to use the pins as the fiduciary markers allows us to eliminate the need for a separate surgery to place the pins and reduces the overall surgical time," commented Dr. Bargar. Professor Dr. Borner, the Medical Director of BGU Clinical in Frankfurt, Germany, was present during the surgery and provided clinical support in the landmark Pinless THR surgery. Prof. Dr. Borner has performed over 3,000 ROBODOC hip and knee surgeries since 1994 and he is known worldwide as the leader for robotic joint replacement surgeries.
Dr. Ramesh C. Trivedi, President & CEO of Integrated Surgical Systems added, "We are delighted to finally start the clinical trials for the DigiMatch (Pinless) ROBODOC System in the USA. It has been in routine use in Europe since September of 1998. There both the patients and surgeons prefer this pinless technology since it does away with any pre-operative surgery to place the pins and patients recover sooner. It also eliminates the occasional post operative knee pain experienced by the patient. In addition, it reduces the cost of the entire procedure."
The other two sites are scheduled to join Sutter Medical Center in clinical trials in the next few weeks. All the sites will use the VerSys line of cementless hip prosthesis made by Zimmer, Inc. a subsidiary of Bristol-Myers Squibb (NYSE: BMY). The clinical study, requiring a total of 160 patients is expected to take five months to complete. Following the multicenter clinical trials, U.S. surgeons and Integrated Surgical Systems expect to obtain FDA approval by the end of 2001.
The Products:
ROBODOC is the robotic surgery system of ISS that is used for total joint arthoplasties. ROBODOC consists of a robotic arm assembly and a PC-based 3-D planning station called ORTHODOC(R). ISS has installed 37 ROBODOC systems worldwide.
The ISS neurosurgery product, NeuroMate(TM), is the first robotic technology based system for use in stereotactic brain surgery. NeuroMate consists of a robotic arm assembly and a PC-based planning system. NeuroMate also interfaces with other popular planning stations offered by third-party vendors. ISS has installed 16 NeuroMate systems in the U.S., Europe, and Japan.
The Company:
Integrated Surgical Systems, Inc. develops, manufactures, markets and services computer-controlled, image-directed robotic products for surgical applications. ISS produces the ROBODOC Surgical Assistant System (ROBODOC), which is designed for orthopedic applications. The ROBODOC System has been used to perform successful total hip replacement surgeries on more than 7,300 patients worldwide. ROBODOC is currently being marketed in Europe and the Middle East. NeuroMate(TM), an ISS neurosurgery product, is the first robotic technology for use in stereotactic brain surgery and it has supported to date over 3,000 neurosurgical procedures.
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 a registered trademark of Integrated Surgical Systems, Inc. NeuroMate(TM) is a trademark of Integrated Surgical Systems, S.A. |
