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Intuitive Surgical Perspective on da Vinci® Surgery Safety, Clinical Data and Marketing

For more than 15 years, Intuitive Surgical has focused on improving surgical outcomes through advanced technology. Our products have allowed more than 1.5 million patients to receive the benefits of minimally invasive, robotic-assisted surgery.

Proven Safety & Efficacy of da Vinci Surgery
The most appropriate way to evaluate safety and efficacy of any surgical approach is through clinical data, and the clinical literature (peer-reviewed publications written by surgeons) for robotic-assisted surgery is extensive.

Recent clinical literature includes several studies that use national databases to evaluate thousands of patient's surgical outcomes. These studies compare da Vinci Surgery to non-robotic-assisted approaches for specific procedures, such as prostatectomy (removal of the prostate) and hysterectomy (removal of the uterus).

For prostatectomy, two of the larger studies1,2 demonstrate that da Vinci Prostatectomy is safer than the prior standard of open surgery across a large number of patients. Complications, death, blood loss, and length of hospital stay are all substantially better for da Vinci Prostatectomy by a statistically significant margin.

For hysterectomy, two representative studies3,4 show that da Vinci Hysterectomy is as safe as laparoscopy and also reduces the length of hospital stays.

Today, da Vinci Surgery is clearly displacing traditional open surgery and the complications and costs associated with it.

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Comprehensive Marketing & Patient Education
We believe in educating hospitals, surgeons, and patients about the existence of da Vinci Surgery, its use and potential benefits, and the risks and alternatives. Intuitive is an industry leader in providing a fair and appropriate discussion of these points in our marketing and promotional materials.

Selection of a treatment approach requires a detailed dialogue between a surgeon and a patient about the patient's specific conditions and the surgeon's experience with all types of surgery. Although we believe that marketing plays a role in educating patients and surgeons about surgical options, the ultimate decision must always be made by the patient and surgeon through their personal consultation.

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The links below lead to material relevant to media professionals, including a da Vinci® Surgery electronic press kit, da Vinci Surgery video, Intuitive Surgical press releases, media coverage of the company, the da Vinci System and popular media coverage of da Vinci Surgery at hospitals worldwide.

If you have a media related inquiry,  please contact the corporate communications team at corpcomm@intusurg.com.

Or you may call the corporate communications media line at 408-523-7337 and someone will return your call promptly.  From outside the United States, please call +41.21.821.20.00. The media line is staffed from 6am PT - 6pm PT. (9am ET - 9pm ET)

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For non-media related questions, please contact our corporate headquarters.


1 Liu et. al., "Perioperative Outcomes for Laparoscopic and Robotic Compared with Open Prostatectomy Using the National Surgical Quality Improvement Program (NSQIP) Database", European Urology (2013), doi:10.1016/j.eurouro.2013.03.080
2 Kowalczyk et. al., "Temporal National Trends of Minimally Invasive and Retropubic Radical Prostatectomy Outcomes from2003 to 2007: Results from the 100% Medicare Sample", European Urology (2011), doi:10:1016/j.eurouro.2011.12.020
3 Lau et. al. "Outcomes and Cost Comparisons After Introducing a Robotics Program for Endometrial Cancer Surgery", Obstetrics & Gynecology (2012), DOI: 10.1097/AOG.ob013e31824c0956
4 Wright et. al. "Robotically Assisted vs Laparoscopic Hysterectomy Among Women With Benign Gynecologic Disease", JAMA 2013;309(7):689-698
5 MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.

Note: Press releases and published articles are provided for informational purposes only. Material contained in these publications does not imply that specific clinical uses are safe and effective nor do they imply regulatory clearance unless specifically stated. Please see our FDA Clearance page for a description of clinical uses for which the da Vinci® Surgical System has been cleared for use in the United States.

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All surgery presents risk, including da Vinci® Surgery and other minimally invasive procedures.  Serious complications may occur in any surgery, up to and including death. Examples of serious or life-threatening complications which may require hospitalization include injury to tissues or organs, bleeding, infection or internal scarring that can cause long-lasting dysfunction or pain. Temporary pain or nerve injury has been linked to the inverted position often used during abdominal and pelvic surgery. Risks of surgery also include potential for equipment failure and human error. Risks specific to minimally invasive surgery may include: A long operation and time under anesthesia, conversion to another technique or the need for additional or larger incisions.  If your surgeon needs to convert the procedure, it could mean a long operative time with additional time under anesthesia and increased complications. Temporary pain or discomfort may result from pneumoperitoneum, the presence of air or gas in the abdominal cavity used by surgeons in minimally invasive surgery. Research suggests that there could be an increased risk of incision-site hernia with single-incision surgery. Results, including cosmetic results, may vary.  Patients who bleed easily, who have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci® Surgery. For more complete information on surgical risks, safety, and indications for use, please refer to http://www.davincisurgery.com/safety/. Patients should talk to their doctors about their surgical experience and to decide if da Vinci Surgery is right for them. Other options may be available. Intuitive Surgical reviews clinical literature from the highest level of evidence available to provide benefit and risk information about use of the da Vinci Surgical System in specific representative procedures. We encourage patients and physicians to review all available information on surgical options and treatment in order to make an informed decision. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed.

© 2014 Intuitive Surgical. All rights reserved. All product names are trademarks or registered trademarks of their respective holders.