Source: Intuitive Surgical, Inc.
SUNNYVALE, Calif., Dec. 12, 2011 (GLOBE NEWSWIRE) -- Intuitive Surgical, Inc. (Nasdaq:ISRG), the global leader in minimally invasive robotic-assisted surgery, today announced that it received FDA clearance to market its Single-Site Instrumentation for laparoscopic cholecystectomy procedures, the surgical removal of the gall bladder.
Single-Site Instrumentation provides da Vinci Si customers with a technology that enables cholecystectomy via a single incision, while providing the benefits of traditional multi-port da Vinci Surgery— enhanced surgical precision, control and stability and 3D HD visualization.
The Single-Site suite of instruments and accessories consists of the Single-Site Port, specialized curved cannulae and 5mm semi-rigid instruments, which are compatible with any da Vinci Si Surgical System. The design of the instruments and the da Vinci System's Remote Center Technology are intended to reduce instrument crowding and external collisions typically associated with hand-held, laparoscopic single-incision devices.
Gary Guthart, CEO, Intuitive Surgical Inc., stated, "We are pleased with this clearance for our Single-Site instruments for use in laparoscopic cholecystectomy using the da Vinci System. We plan to immediately initiate a controlled rollout of these products in the US, while continuing our rollout in Europe. As we learn more about our customers' needs within single-incision surgery, we anticipate future submissions to the US FDA and other global regulatory agencies related to expansion of the cleared indications for use, as well as additional Single-Site instruments."
All da Vinci Si Surgical Systems are compatible with Single-Site™ Technology. The standard da Vinci and the da Vinci S Systems are not compatible with Single-Site Technology.
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, California, is the global technology leader in robotic-assisted, minimally invasive surgery (MIS). Intuitive Surgical develops, manufactures and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The company's mission is to extend the benefits of minimally invasive surgery to the broadest possible base of patients. Intuitive Surgical -- Taking surgery beyond the limits of the human hand.™
About the da Vinci Surgical System
The da Vinci Surgical System is a breakthrough surgical platform designed to enable complex surgery using a minimally invasive approach. The da Vinci Surgical System consists of an ergonomic surgeon console or consoles, a patient-side cart with three or four interactive robotic arms, a high-performance vision system and proprietary EndoWrist instruments. Powered by state-of-the-art robotic and computer technology, the da Vinci Surgical System is designed to scale, filter and seamlessly translate the surgeon's hand movements into more precise movements of the EndoWrist instruments. The net result is an intuitive interface with breakthrough surgical capabilities. By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, the da Vinci Surgical System makes it possible for more surgeons to perform minimally invasive procedures involving complex dissection or reconstruction. This ultimately has the potential to raise the standard of care for complex surgeries, translating into numerous potential patient benefits, including less pain, a shorter recovery and quicker return to normal daily activities.
Intuitive®, Intuitive Surgical®, da Vinci®, da Vinci® S™, da Vinci® S™ HD Surgical System, da Vinci® Si™, da Vinci® Si-e™, EndoWrist®, Single-Site™, DVSTAT® and InSite® are trademarks or registered trademarks of Intuitive Surgical, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are necessarily estimates reflecting the best judgment of our management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. Risks and uncertainties associated with adoption of Single Site Instrumentation for Cholecystectomy procedures is subject to patient demand and surgeon adoption which cannot be predicted; and, use of Single Site Instrumentation for procedures other than Cholecystectomy will be subject to our ability to obtain future FDA clearances. In addition, forward-looking statements should be considered in light of other various important factors, including, but not limited to: The impact of global and regional economic conditions and related credit markets and related impact on health care spending; health care reform legislation in the United States and its implications on hospital spending, reimbursement and fees which will be levied on certain medical device revenues; timing and success of product development and market acceptance of developed products; procedure counts; regulatory approvals, clearances and restrictions; guidelines and recommendations in the health care and patient communities; intellectual property positions and litigation; competition in the medical device industry and in the specific markets of surgery in which Intuitive Surgical operates; unanticipated manufacturing disruptions; delays in regulatory approvals of new manufacturing facilities or the inability to meet demand for products; and the results of the year-end audit and other risk factors under the heading ``Risk Factors'' in our report on Form 10-K for the year ended December 31, 2010, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. Statements concerning forecasts, revenue growth, procedure growth, future financial results, and statements using words such as "estimate," "project,'' "plan,'' "intend,'' "expect,'' "anticipate,'' "believe,'' "targeted" and similar expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
While clinical studies support the effectiveness of the da Vinci Surgical System when used in minimally invasive surgery, individual results may vary. There are no guarantees of outcome. All surgeries involve the risk of major complications. Before you decide on surgery, discuss treatment options with your doctor. Understanding the risks of each treatment can help you make the best decision for your individual situation. Surgery with the da Vinci Surgical System may not be appropriate for every individual; it may not be applicable to your condition. Always ask your doctor about all treatment options, as well as their risks and benefits. Only your doctor can determine whether da Vinci Surgery is appropriate for your situation. The clinical information and opinions, including any inaccuracies expressed in this material by patients or doctors about da Vinci Surgery, are not necessarily those of Intuitive Surgical, Inc. and should not be considered as substitute for medical advice provided by your doctor. © 2011 Intuitive Surgical. All rights reserved. PN 875786 Rev A 12/11
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