Computer Motion ZEUS Robotic Surgical System Receives FDA Regulatory Clearance.

Business Editors & Health/Medical Writers

SANTA BARBARA, Calif.--(BW HealthWire)--Oct. 9, 2001

Food and Drug Administration (FDA) Clears ZEUS(R) System for Use With

a Variety of Instruments for Laparoscopic and Thoracic Surgery 

Computer Motion, Inc. (Nasdaq:RBOT), the world's leading developer of surgical robotic systems, today announced regulatory clearance granted by the Food and Drug Administration (FDA) for the ZEUS(R) Robotic Surgical System. The FDA decision clears U.S. surgeons to use a variety of instruments to perform a wide range of robotically assisted laparoscopic and thoracic procedures. The system is intended to assist in the accurate control of blunt dissectors, retractors, atraumatic graspers and stabilizers during laparoscopic and thoracoscopic surgery.

Dr. E. Carmack Holmes, Chairman of the Department of Surgery at UCLA Medical Center, said, "Robotic surgery is going to take us places we have never been able to go inside the human body, and allow us to help patients in new and exciting ways." He continued, "The ZEUS FDA clearance is certainly good news for our surgeons, and even better news for our patients."

The FDA decision also clears the way for the company to market the ZEUS System for sale in the U.S. To date the company has 25 ZEUS Systems placed at procedure development and clinical development sites in the U.S. and 24 ZEUS Systems at facilities abroad.

Robert W. Duggan, Chairman and Chief Executive Officer of Computer Motion, said, "We believe that surgeons in the U.S. will take advantage of this new clearance to rapidly advance a new era of patient-friendly surgery." Mr. Duggan continued, "This FDA regulatory clearance for the fundamental ZEUS platform is one of the most significant events in the history of Computer Motion. I am very confident our regulatory team is setting the stage for additional important ZEUS clearances."

The ZEUS Robotic Surgical System is designed to make endoscopic procedures easier to perform and safer for the patients. The system is intended to enable increased levels of endoscopic precision, dexterity and surgeon ergonomic comfort. The system has been used in a variety of procedures ranging from simple excisional surgeries including gall bladder removal, to complex reconstructive surgeries like endoscopic beating heart coronary artery bypass.

Yulun Wang, Ph.D., Founder and Chief Technical Officer of Computer Motion, stated, "Our surgeon partners continue to drive our research and development efforts to provide the safest and most reliable products available in the market today. We wish to acknowledge the efforts of all these individuals and institutions -- it is through the dedication and commitment of these medical professionals that we are able to remain on the vanguard of this new and important field."

Computer Motion is a high-tech medical device company evolving surgical practices to enhance patient lives. The company develops, manufactures and markets proprietary computer-enhanced and robotic surgical systems, which enhance surgeons' capabilities, improve outcomes and reduce costs.

Computer Motion plays a significant role in transitioning the surgical community from current open procedures to increasingly demanded endoscopic procedures. Computer Motion's products include the ZEUS(R) robotic system for new minimally invasive microsurgical procedures, such as endoscopic beating heart bypass surgery, and the HERMES(TM) Control Center, a centralized system that enables the surgeon to voice control a network of "smart" medical devices.

The AESOP Robotic Endoscope Positioner is the first FDA-cleared surgical robot, and the ZEUS(R) Robotic Surgical System is CE-Marked for commercial sale in the European Community. Computer Motion has completed an FDA-approved Phase 1 Investigational Device Exemption (IDE) coronary bypass study and has initiated an IDE mitral valve surgery, general laparoscopic and thoracic studies with the ZEUS system. Also, the company has begun the second phase of its tubal reanastomosis study. The company's Web site is www.ComputerMotion.com.

This press release contains forward-looking statements concerning the company's business and products. Actual results may differ materially depending on a number of risk factors, including the risks of competition and competing technologies, duration or suspension of clinical studies, regulatory clearances and approvals, and physician, hospital and payor acceptance of the company's products. These factors and other risks inherent in the company's business are described from time to time in the company's Securities and Exchange Commission filings, including its Annual Report on Form 10-K. The company undertakes no obligation to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof to reflect the occurrence of unanticipated events.