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Frequently Asked Questions

What is robotic-assisted surgery?
What are da Vinci® Surgical Systems and who are they made by?
What types of procedures are da Vinci Surgical Systems approved for?
How is surgery performed with a da Vinci Surgical System and is it different than laparoscopy?
How common is robotic-assisted minimally invasive surgery?
Where is the da Vinci Surgical System being used now?
Why are the systems called da Vinci?
Is robotic-assisted surgery safe?
How are surgeons trained in robotic-assisted surgery?
Is the operating surgeon in the room? Can they operate remotely?
What is the da Vinci Firefly technology and how does it work?
Is future competition a concern for Intuitive Surgical?
What is Intuitive Surgical’s view on the future of robotic-assisted surgery?

 

Q. What is robotic-assisted surgery?

A. Robotic-assisted surgery is a form of minimally-invasive surgery (MIS) that is performed through small incisions. During a da Vinci robotic-assisted surgical procedure, the surgeon sits at a console while viewing a high-definition, 3D image of the patient’s target anatomy. The surgeon’s hand, wrist and finger movements made at the console (outside of the surgical field) are translated into precise, real-time movement of surgical instruments attached to three or four robotic arms.

Robotic-assisted surgery allows surgeons to perform many types of complex procedures with more precision, flexibility and control than is possible with conventional techniques.

Q. What are da Vinci Surgical Systems and who are they made by?

Made by Intuitive Surgical Inc. in Sunnyvale, California, da Vinci Xi® Surgical Systems are advanced robotic-assisted surgical platforms designed to expand a surgeon’s operating capabilities and offer a state-of-the-art minimally invasive option for patients. To date, Intuitive Surgical has launched four robotic-assisted surgical system models, including the latest model, the da Vinci Xi® System.1

By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, da Vinci Surgical Systems make it possible for skilled surgeons to perform minimally invasive procedures involving complex dissection or reconstruction.

Q. What types of procedures are da Vinci Surgical Systems approved for?

A. In 2000, the da Vinci Surgical System became the first robotic-assisted surgical system cleared by the FDA for general laparoscopic surgery.

Since the year 2000, da Vinci Surgical Systems have been used for more than 3 million minimally invasive procedures in surgical specialties, including:

  • Urology (prostate, bladder and kidney cancer),
  • Gynecology (benign and cancerous hysterectomy; myomectomy),
  • General surgery (colorectal; ventral and inguinal hernia repair),
  • Thoracic surgery (lobectomy; mediastinal mass,
  • Cardiac surgery (mitral valve repair; pulmonary resections).

More detailed information on surgical specialties is available at: http://davincisurgery.com

Q. How is surgery performed with a da Vinci Surgical System and is it different than laparoscopy?

Both traditional laparoscopy and robotic-assisted surgery are forms of minimally-invasive surgery.

In traditional laparoscopic surgery, the surgeon performs the procedure holding rigid instruments and views the surgical area through an endoscopic camera that is projected onto a monitor. In use, the tools move in the opposite direction of the surgeon's hands due to the pivot point design. The tools used in traditional laparoscopy have four degrees of movement.

With da Vinci Surgical Systems, the surgeon sits at a Surgeon Console while viewing a high-definition, 3D image of the target anatomy. The surgeon's fingers grasp the master controls with their hands and wrists naturally positioned relative to their body.

Three or four robotic arms, which hold an endoscope (camera) and surgical instruments, carry out the surgeon's commands. The System seamlessly translates the surgeon's hand, wrist and finger movements into precise, real-time movement of the surgical instruments positioned inside the patient’s body. These instruments can bend and rotate far greater than both traditional lap instruments and the human wrist. Every surgical maneuver is under the direct control of the surgeon.

During a surgical procedure, the da Vinci Vision System displays high-definition, 3D imagery to the surgeon via the Surgeon Console and to the operating room staff via the Vision Cart.

Q. How common is robotic-assisted minimally invasive surgery?

Since 2000, da Vinci Surgical Systems have been used in more than 3 million minimally invasive procedures performed world-wide.

In urology, for example, the use of da Vinci technology brought the rate of open prostatectomies down from 95% in 2003 to 12% in just 10 years, with robotic-assisted surgery accounting for 87% of these procedures in 2013.2

Q: Where is the da Vinci Surgical System being used now?

A. da Vinci Surgical Systems are in use in:

  • 64 countries worldwide
  • All 50 U.S. States
  • All top-ranked U.S. hospitals for cancer, urology, gynecology or gastroenterology, including: Memorial Sloan Kettering Cancer Center, University of Texas-M.D. Anderson Cancer Center, Mayo Clinic hospitals, Johns Hopkins Hospital and the Cleveland Clinic Hospital.

Q. Why are the systems called da Vinci?

A. The name “da Vinci” pays homage to Leonardo da Vinci, the 15th century inventor, painter, philosopher and Renaissance man. Leonardo da Vinci is widely known for advancing the study of human anatomy. He was also intrigued by mechanics and automation, which eventually led to the design of the first known robot, "Leonardo's Robot," which was likely made around the year 1495.

Q: Is robotic-assisted surgery safe?

A: Robotic-assisted surgery is an important surgical treatment option that is safe and offers many potential benefits for patients, surgeons and hospitals when used appropriately and with proper training.

The breadth of literature regarding da Vinci Surgery is extensive. More than 10,000 peer-reviewed studies and reports examining the use of the da Vinci Surgical System in various procedures have been published. Within this body of evidence, many benefits of robotic-assisted surgery for patients have been demonstrated including: less blood loss, fewer complications, shorter hospital stays, smaller incisions for minimal scarring, and faster recovery and return to daily life.3-10

Q. How are surgeons trained in robotic-assisted surgery?

A. Intuitive Surgical, the United States Food and Drug Administration, hospitals and professional medical societies all have a role in training. While Intuitive Surgical has developed a world-class program that supports surgeons in developing the knowledge and skills needed to use da Vinci technology safely and efficiently, individual hospitals are responsible for directing the training requirements and credentialing of the robotic-assisted surgeons who receive privileges at their facilities.

Q. Is the operating surgeon in the room? Can they operate remotely?

A. The surgeon performing the procedure is located at a console in the operating room in close proximity to the patient and surgical support staff. The da Vinci Surgical Systems could theoretically be used to operate over long distances. However, optimizing the system for remote or telesurgery applications is not a focus of the company's product design and development efforts.

Q. What is the da Vinci Firefly technology and how does it work?

A.Intuitive Surgical’s Firefly Fluorescence Imaging enables surgeons to switch between standard, visible light and near-infrared imaging during MIS procedures. When a surgeon uses Firefly imaging in conjunction with an injectable fluorescent dye, tissue with blood flow is highlighted in a green color and tissue without blood flow appears gray in the surgeon's view, helping to identify target anatomy.

Q. Is future competition a concern for Intuitive Surgical?

Competition only confirms that robotic-assisted surgery continues to grow to the point that other companies can no longer sit on the sidelines. Robotic-assisted surgery will continue to flourish around the globe and competitors have been expected.

With over 20 years of experience in the field, Intuitive Surgical has grown to have a deep understanding of robotic-assisted surgical technology and surgeon needs, and has developed a critical ecosystem. This begins with our robotic platforms and includes a broad instrument product line, imaging solutions, training programs and technology, clinical validation, field clinical support, field technical support, and program optimization. Surgeons, hospitals, and patients benefit from the large community of users within Intuitive Surgical’s robotic-assisted surgical ecosystem, which drives economic value for hospital programs and can deliver improved surgical outcomes.

Q. What is Intuitive Surgical’s view on the future of robotic-assisted surgery?

A. As the clinical issues and advancement opportunities evolve, so too will our thinking about innovation and how to solve problems. Select areas of emphasis include:

  • Imaging systems, like Intuitive Surgical’s Firefly Fluorescence Imaging System, to enable and enhance real-time visual assessment of vessels, blood flow and tissue.
  • Developing and improving systems that are even less invasive to the body during entry such as those that use natural orifices in the body and technologies that are more precise and smart in interacting with tissue.
  • Advancing capabilities to give real-time feedback to surgeons and staff in the operating room.

1. Not all da Vinci Surgical Systems are available in all markets.
2. Inpatient data: Nationwide Inpatient Sample (NIS), Healthcare Cost and Utilization Project (HCUP), Agency for Healthcare Research and Quality.
3. Pilecki, M., et al. (2014). “National Multi-Institutional Comparison of 30-Day Postoperative Complication and Readmission Rates Between Open Retropubic Radical Prostatectomy and Robot-Assisted Laparoscopic Prostatectomy Using NSQIP.” Journal of Endourology. pp. 430–436.
4. Lau, S., et al. (2012). “Outcomes and cost comparisons after introducing a robotics program for endometrial cancer surgery.” Obstetrics and Gynecology. 119(4): 717-724.
5. Paley, P. J., et al. (2011). “Surgical outcomes in gynecologic oncology in the era of robotics: Analysis of first 1000 cases.” American Journal of Obstetrics and Gynecology 204(6): 551.e551-551.e559.
6. Kang, J., et al. (2012). “The impact of robotic surgery for mid and low rectal cancer: A case-matched analysis of 3-arm comparison--open, laparoscopic, and robotic surgery.” Annals of Surgery.
7. Trinh QD, et al. “Perioperative outcomes of robot-assisted radical prostatectomy compared with open radical prostatectomy: results from the nationwide inpatient sample.” Eur Urol. 2012 Apr; 61(4):679-85.
8. Tewari A, et al. “Positive Surgical Margin and Perioperative Complication Rates of Primary Surgical Treatments for Prostate Cancer: A Systematic Review and Meta-Analysis Comparing Retropubic, Laparoscopic, and Robotic Prostatectomy.” Eur Urol. 2012 Feb 24.
9. Khalifeh A, et al. “Comparative Outcomes and Assessment of Trifecta in 500 Robotic and Laparoscopic Partial Nephrectomies: A Single Surgeon Experience.” J Urol. 2012 Oct 16. pii: S0022-5347(12)05220-2. doi: 10.1016/j.juro.2012.10.021.
10. Tollefson, MK et al. (2011). “Robotic-assisted Radical Prostatectomy Decreases the Incidence and Morbidity of Surgical Site Infections.” Urology, 78(4):827-831.

Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain. Risks of surgery also include the potential for equipment failure and/or human error. Individual surgical results may vary.

Risks specific to minimally invasive surgery, including da Vinci Surgery, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; temporary pain/discomfort from the use of air or gas in the procedure; a longer operation and time under anesthesia and conversion to another surgical technique. If your doctor needs to convert the surgery to another surgical technique, this could result in a longer operative time, additional time under anesthesia, additional or larger incisions and/or increased complications.

Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci® Surgery. Patients should talk to their doctor to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. For Important Safety Information, including surgical risks, indications, and considerations and contraindications for use, please also refer to http://www.intuitivesurgical.com/safety. Unless otherwise noted, all people depicted are models.

Product names are trademarks or registered trademarks of their respective holders.

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