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Computer Motion Announces First Minimally Invasive Robotic Heart Valve Surgery in the United States.


Business Editors & Medical/High Tech Writers

TORONTO--(BUSINESS WIRE)--May 1, 2000

The ZEUS(TM) Robotic Surgical System is approved for

a new FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 clinical study on minimally invasive

mitral valve procedures

At the 80th Annual Meeting of the American Association of Thoracic Surgery, Computer Motion, Inc. (Nasdaq:RBOT RBOT Rotating Bomb Oxidation Test ), the leader in medical robotics, and New York University New York University, mainly in New York City; coeducational; chartered 1831, opened 1832 as the Univ. of the City of New York, renamed 1896. It comprises 13 schools and colleges, maintaining 4 main centers (including the Medical Center) in the city, as well as the  Medical Center, the leader in minimally invasive heart surgery techniques, announced today the successful completion of the first minimally invasive robotic heart valve surgery in the United States. Stephen Colvin, MD, Chief of Cardiothoracic Surgery, and Eugene A. Grossi, MD, Director of Cardiac Surgical Research, of New York University School of Medicine used the Computer Motion ZEUS(TM) Robotic Surgical System to perform a minimally invasive mitral valve repair Mitral valve repair is a cardiac surgery procedure performed by cardiac surgeons to treat stenosis (narrowing) or regurgitation (leakage) of the mitral valve. The mitral valve is the "inflow valve" for the left side of the heart.  on a 50-year-old male as part of a United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 approved Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  (IDE) Phase I clinical study.

The ZEUS System assisted Drs. Colvin and Grossi in performing the minimally invasive procedure Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an  through a mini-thoracotomy (a 6-cm incision) in the patient's chest. As a result, the typical patient pain and trauma associated with a conventional approach to a valve repair is avoided. The evening after surgery, the patient reported little pain and was mobile and comfortable. The surgeons added, "The post-operative transesophageal echocardiogram ech·o·car·di·o·gram
n.
A visual record produced by echocardiography.


Echocardiogram
A non-invasive ultrasound test that shows an image of the inside of the heart.
 (TEE) revealed that the mitral valve is no longer leaking, and we expect the patient to be discharged in a few days."

Coupling its expertise in computer-enhanced systems with its vast clinical experience of more than 100,000 surgical procedures with medical robots, Computer Motion has developed the ZEUS Robotic Surgical System to overcome existing clinical constraints and to meet market demand for a more patient-friendly approach to surgery. While seated at the ZEUS workstation a few feet away from the patient, the surgeon controls three robotic arms on the operating table, which become his or her eyes and hands for the minimally invasive surgery minimally invasive surgery Laparoscopic surgery, see there. See Laparoscopic cholecystectomy. . While viewing a video monitor to see the operative site, the surgeon manipulates conventional minimally invasive instrument handles at the workstation, as the ZEUS System translates these movements with scaled-down precision to the instrument tips at the operative site. The surgeon also has the ability to move the endoscope endoscope, any instrument used to look inside the body. Usually consisting of a fiber-optic tube attached to a viewing device, endoscopes are used to explore and biopsy such areas as the colon and the bronchi of the lungs.  (a slender optical tube which is passed into the patient's body to see the operative site) using simple voice commands to directly control the visualization during a procedure.

"The ZEUS System enables a new level in visualization and ergonomics for the surgeon," stated Dr. Grossi. "With robotic visualization, I can now work from an operative field of view with 10 to 15 times magnification--a significant increase over the standard surgical loops, which only provide 3 to 4 times magnification. The ZEUS System allows me to ergonomically voice control the endoscope and surgical instruments in real-time from a workstation instead of standing throughout a long and complex procedure where my arms are not well supported. Also, the ZEUS System computer interface has the ability to filter out human hand tremor to provide me with more exact needle placement, which is critical to the success of heart surgery," added Dr. Grossi.

Dr. Colvin expressed cautious optimism for the use of the ZEUS System for heart valve surgery. "These are exciting times for surgeons as we begin to incorporate this phenomenal technology into our practice of minimally invasive cardiac surgery minimally invasive cardiac surgery Interventional cardiology Any of a number of techniques–MIDCAB, off-pump coronary-artery bypass, minimally invasive valve surgery, port-access coronary surgery, and port-access valve surgery–increasingly being used to . We used to think our eyes and hands limited us. Now, we have the technology to go beyond the limits of human performance."

"The New York University Medical Center is world-renowned in minimally invasive heart valve surgery," said Robert W. Duggan, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Computer Motion. "Over the past year, they have already integrated our AESOP Aesop (ē`səp, ē`sŏp), legendary Greek fabulist. According to Herodotus, he was a slave who lived in Samos in the 6th cent. B.C. and eventually was freed by his master. (R) technology into their surgical practice and have used it to teach minimally invasive surgical techniques via teleconference, which made their recent evolution to robotic cardiac surgery with the ZEUS System both rapid and successful. We are excited to be working with New York University Medical Center to pioneer this new procedure and to lead the advancement of minimally invasive surgery."

Added Mr. Duggan, "We are pursuing parallel clinical trails covering both cardiovascular and general laparoscopic surgery. Our objective is to demonstrate the safety and effectiveness of the ZEUS System for a wide range of surgeries." To date, Computer Motion has completed Phase I trials for the use of the ZEUS System in a cardiac bypass procedure and an endoscopic tubal Tubal (t`bəl), in the Bible, son of Japheth.  reanastomosis procedure, in which fallopian tubes that have previously been ligated ("tied") to prevent pregnancy are reconnected.

Computer Motion, the world leader in medical robotics, is creating the cornerstone technologies and products for the Intelligent Operating Room(TM). The company develops, manufactures and markets proprietary computer-enhanced and robotic surgical systems, which enhance surgeons' capabilities, improve outcomes and reduce costs. In addition to the ZEUS Robotic Surgical System, Computer Motion's products include the voice-controlled AESOP(R) endoscope positioning system and the HERMES(TM) Control Center, a centralized system which enables the surgeon to voice control a network of "smart" medical devices. ZEUS is CE-Marked for commercial sale in the European Community. Computer Motion and Medtronic (NYSE NYSE

See: New York Stock Exchange
:MDT MDT
abbr.
Mountain Daylight Time


MDT (in the US and Canada) Mountain Daylight Time

MDT n abbr (US) (= mountain daylight time) →
) are co-marketing ZEUS. 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.
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:May 1, 2000
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