Intuitive Surgical's da Vinci System Used to Perform First Ever Totally Endoscopic Heart Bypass Procedure in the United States

January 17, 2002 at 5:44 PM EST
MOUNTAIN VIEW, Calif., Jan 17, 2002 (BUSINESS WIRE) -- Intuitive Surgical, Inc. (Nasdaq:ISRG), the industry leader in operative robotic surgery, announced today that a team of cardiac surgeons led by Dr. Michael Argenziano from New York-Presbyterian Hospital's Columbia Presbyterian Medical Center has completed the first ever closed-chest, totally endoscopic coronary artery bypass (TECAB) surgery in the United States. This TECAB procedure, which was performed on Tuesday using the da Vinci Surgical System from start to finish, begins Intuitive's Food and Drug Administration (FDA) TECAB clinical study that will involve several major medical centers in the United States.

Heart disease is the leading cause of death in the United States and coronary artery bypass grafting or "CABG" is the most commonly performed heart operation. Approximately 375,000 bypass surgeries are performed each year in the United States. Traditionally, heart bypass surgeries require a large 8- to 10-inch incision through the chest wall. In contrast, TECAB procedures using the da Vinci System require only three or four pencil-sized holes -- or "ports" -- made between the ribs. Through these ports, two robotic "arms" and a camera system gain exposure to the heart, allowing the surgeon to perform surgery without opening the chest.

This highly reproducible mode of totally endoscopic bypass with the da Vinci System offers several potential clinical benefits to patients. For example, studies show that patients who have minimally invasive operations may be able to leave the hospital days earlier than patients recovering from conventional cardiac surgery. Dr. Michael Argenziano, Director of Robotic Cardiac Surgery at Columbia Presbyterian Medical Center said, "The three-dimensional visualization and precise, intuitive instrument control allowed us to perform a coronary bypass operation exactly as we do in conventional cases, except without an incision. It is this ability of the da Vinci System to literally transport the surgeons hands and eyes inside the chest that make it a revolutionary technology in cardiac surgery."

Although this is the first closed-chest, totally endoscopic bypass procedure ever performed in the United States, the da Vinci System has already been used to perform over 200 TECABs at multiple sites throughout Europe. "To be able to offer this same benefit to American patients and surgeons is very rewarding. We are thrilled to be part of a team that is delivering totally endoscopic solutions to the cardiac care patient group," stated Lonnie Smith, President & CEO of Intuitive Surgical, Inc.

Intuitive Surgical is also conducting two other FDA-sanctioned cardiac clinical studies. "We are already well into our 10-site clinical study for Mitral Valve Repair with the da Vinci System, and our study for Atrial Septal Defect closure is progressing well. The results thus far appear quite promising," commented Mr. Smith.

    About the da Vinci Surgical System:
First cleared by the FDA in 1997 for assisting surgery, and in July 2000 for actual surgery, the da Vinci Surgical System is still the only operative robotic surgery system cleared by the FDA to perform surgery. FDA clearances so far include use in laparoscopic, thoracoscopic, and radical prostatectomy surgeries. The da Vinci System, however, is not yet cleared for any type of cardiac surgery in the United States. The System consists of a surgeon's viewing and control console having an integrated, high-performance InSite 3-D vision system, a patient-side cart consisting of three robotic arms that position and precisely maneuver endoscopic instruments and an endoscope, and a variety of articulating EndoWrist Instruments. By integrating computer-enhanced technology with surgeons' technical skills, Intuitive believes that its System enables surgeons to perform better surgery in a manner never before experienced. The da Vinci Surgical System seamlessly and directly translates the surgeon's natural hand, wrist and finger movements on instrument controls at the surgeon's console outside the patient's body into corresponding micro-movements of the instrument tips positioned inside the patient through small puncture incisions, or ports.

The statements contained in this release may be deemed to contain "forward-looking statements." Such statements are indicated by words or phrases such as "anticipates," "estimates," "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: da Vinci(TM), EndoWrist(TM), InSite(TM), Intuitive(R) and Intuitive Surgical(R) are trademarks of Intuitive Surgical, Inc.

CONTACT: Intuitive Surgical, Inc. Lyndel Thompson, 650/237-7112