First Complete Computer-enhanced Mitral Valve Repair Performed in the United States.

Business/Health Editors

MOUNTAIN VIEW, Calif.--(BW HealthWire)--May 10, 2000

FDA Clinical Studies Begin at East Carolina University using the

da Vinci(tm) Surgical System for Minimally Invasive

Intra-Cardiac Procedures

Today, Intuitive Surgical, Inc., a leader in computer-enhanced surgical systems, announced that the surgical team from Brody School of Medicine, East Carolina University/Pitt Memorial Hospital, Greenville, North Carolina, successfully performed an entire mitral valve repair solely using the Company's da Vinci(tm) Surgical System.

Dr. W. Randolph Chitwood, Jr., Dr. Wiley Nifong, Dr. Joseph Elbeery, and the cardiac surgical team from East Carolina University used the da Vinci(tm) Surgical System to perform the mitral valve repair on a 69-year old female patient as part of an Investigational Device Exemption (IDE) clinical study approved by the United States Food and Drug Administration (FDA).

The patient had a posterior middle scallop (P2) prolapse with severe mitral regurgitation and ruptured chords. The total mitral valve repair was completed by resecting the prolapsing segment of the posterior leaflet, closing the cleft, and then inserting a 28mm Cosgrove(tm) Annuloplasty band. The surgeons used 4.0 Cardionyl(tm) suture for the valve repair and 2.0 Ti-Cron(tm) suture for the annular compression and closure suture and ring placement. Their cardiopulmonary bypass (CPB) method used femoral artery inflow and bicaval venous drainage using the femoral and internal jugular veins.

The entire procedure was performed using the da Vinci(tm) Surgical System. Four tiny incisions were made: two 1-cm ports for insertion of the EndoWrist(tm) Instruments (valve forceps, large needleholder, and micro round scissors); one 5-cm right mini-thorocotomy incision, to facilitate suture management and delivery of the ring and endoscope, and one 5-mm port for insertion of the Chitwood(tm) Transthoracic Aortic Cross Clamp.

"I was able to see a whole new operation using the da Vinci(tm) Surgical System," commented Dr. W. Randolph Chitwood, Jr., Professor and Chairman, Department of Surgery, East Carolina University. "While sitting at the console, I was literally immersed inside the patient's left atrium of the heart with an incredible view of the operative field. Not only were my eyes inside the heart, but my hands and wrists had full intra-cardiac articulation due to the micro-electronic wrists at the tips of the instruments."

"This technology allowed me to tie knots and reshape the valve with greater precision than I have experienced with conventional minimally invasive cardiac surgery," proclaimed Chitwood.

"We are very encouraged by the results of our first case. I believe this System will enable the surgeon to perform a better procedure due to the increased visualization and enhanced precision, and the patient will benefit by getting back to normal activities with less pain and trauma associated with the operation."

Chitwood continued: "This case is the first in a series of ten mitral valve repairs that our center will perform for the FDA. We will be testing the feasibility of the System to begin a multi-center trial."

"I am proud of my mother and thrilled that she participated in this trial," proclaimed orthopedic surgeon Ron Benfield, son of the patient. "I routinely use minimally invasive surgery (MIS) in my practice and I am happy to see that computer-enhanced surgery is improving MIS techniques."

About the da Vinci(tm) Surgical System

The da Vinci(tm) Surgical System consists of a surgeon's console, a patient-side cart, a high performance vision system and our proprietary instruments. By placing computer-enhanced technology between the surgeon and patient, we believe that our system enables surgeons to perform better surgery in a manner never before experienced. The da Vinci(tm) Surgical System seamlessly translates the surgeon's natural hand movements on instrument controls at a console into corresponding micro-movements of instruments positioned inside the patient through small puncture incisions, or ports. Our da Vinci(tm) Surgical System is the only commercially available technology that can provide the surgeon with the intuitive control, range of motion, fine tissue manipulation capability and 3-D visualization characteristic of open surgery, while simultaneously allowing the surgeon to work through small ports of minimally invasive surgery.

The statements contained in this release may be deemed to contain "forward-looking statements." Such statements are indicated by words or phrases such as "anticipate," "estimate," "projects," "believes," "intends," "expects" and similar words and phrases. Actual results may differ materially from those expressed or implied in any forward-looking statement as a result of certain risks and uncertainties, including, without limitation, competition and market acceptance of the Company's products, ability to obtain regulatory approvals and third-party reimbursement, ability to raise additional capital and other risks and uncertainties detailed in the Company's Securities and Exchange Commission filings. Prospective investors are cautioned not to place undue reliance on such forward-looking statements.

Note to Editors: Intuitive(tm), da Vinci(tm), EndoWrist(tm) and InSite(tm) are trademarks of Intuitive Surgical, Inc.