Computer Motion Announces FDA Approval to Begin a Multi-Center Cardiac Bypass Study; FDA Regulatory Strategy to Span Five Major Surgical Disciplines.

Business Editors

SANTA BARBARA, Calif.--(BUSINESS WIRE)--Sept. 21, 2000

Computer Motion, Inc. (Nasdaq:RBOT), the pioneer and leader in medical robotics, today announced its new United States Food and Drug Administration (FDA) regulatory clearance strategy for the ZEUS(TM) Robotic Surgical System.

The company is aggressively pursuing parallel approval pathways in both general laparoscopic and cardiac surgery under the 510(k) premarket notification process.

Computer Motion has several clinical studies underway or awaiting FDA Investigational Device Exemption (IDE) approval across five major surgical fields:

- Coronary Artery Bypass Surgery

- Thoracoscopic Surgery

- Cardiovascular Surgery

- General Laparoscopic Surgery, and

- Gynecologic Surgery.

"The object of broad-based clinical studies is to demonstrate that the ZEUS System can safely and effectively perform endoscopic surgery with enhanced patient outcomes," said Richard DeRisio, Vice President, Clinical, Regulatory and Quality Affairs of Computer Motion.

"Our responsibility to our clinical partners, shareholders, employees and future patients is to make sure that our FDA submissions for clinical study approval and 510(k) notification meet or exceed FDA's requirements and expectations for sound and sufficient engineering and clinical data. With this approach, we believe that we will achieve first-pass approval and clearance of our submissions by the FDA," Mr. DeRisio added.

In January 2000, Computer Motion completed a ZEUS System feasibility study for coronary artery bypass grafting (CABG) on 32 patients at three United States cardiac centers, which was the first U.S. study of its kind. The FDA has now approved a multi-center, randomized, controlled CABG trial at 12 ZEUS sites. This is the only FDA-approved multi-center robotic cardiac study in the United States.

Computer Motion anticipates filing a 510(k) submission in the second quarter of 2001 with an approval in the third quarter of 2001.

To further the cardiac regulatory pathway, Computer Motion began a ZEUS System feasibility study on mitral valve repair and replacement in April 2000 at the New York University Medical Center. This trial was also the first of its kind on the United States. Computer Motion will file for a study expansion upon completion of the feasibility phase, which is expected in the fourth quarter of 2000.

The company has also submitted an IDE application to the FDA requesting approval to conduct a clinical trial on harvesting the internal mammary artery, a portion of a standard heart bypass graft procedure. Computer Motion anticipates submitting a 510(k) application for non-intracardiac thoracoscopic clearance in the first quarter of 2001, following the completion of the clinical trial.

In parallel, Computer Motion has been very active in its laparoscopic regulatory strategy. FDA has granted Computer Motion IDE approval for a general surgery study on laparoscopic cholecystectomy (a procedure to remove the gall bladder) and laparoscopic Nissen fundoplication (a procedure to correct acid reflux disease).

The company is projecting 510(k) submission early in the first quarter of 2001. Computer Motion also plans to continue its clinical study on endoscopic tubal reanastomosis (a procedure to reconnect fallopian tubes that have been ligated). FDA has already granted approval to perform 20 additional patients.

In 1998, 10 such procedures were performed. Nine of the patients who participated in this initial study pursued pregnancy. In that initial group, there were six pregnancies reported by the end of the one-year follow-up period.

"We see clinical studies as more than an FDA requirement for clearance of robotic surgical devices. It is an opportunity for Computer Motion to partner with leading academic institutions and medical centers to evolve the ZEUS clinical procedures developed in the United States, Europe, Canada and Asia into validated, standard and reliable robotic surgical methods using the ZEUS System. We believe this evolving global body of clinical experience will assist surgeons in the safe and effective use of our robotic surgery devices in the pursuit of enhanced patient outcomes and decreased healthcare costs," stated Mr. DeRisio.

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

To date, the Computer Motion family of products has safely assisted more than 100,000 minimally invasive procedures across a broad range of surgical disciplines.

Computer Motion's products include the voice-controlled AESOP(R) endoscope positioning system; the HERMES(TM) Control Center, a centralized system which enables the surgeon to voice control a network of "smart" medical devices; and the ZEUS Robotic Surgical System for new minimally invasive microsurgery procedures, such as endoscopic, beating heart bypass surgery.

The ZEUS System is CE-Marked for commercial sale in the European Community and is co-marketed by Computer Motion and Medtronic (NYSE:MDT). 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.