Intuitive Surgical Announces U.S. Clearance for da Vinci Xi Single-Site Instruments and Accessories

March 16, 2016 at 8:33 AM EDT
Leading second generation robotic technology enables surgeons to operate through single incision, resulting in virtually scarless surgery

SUNNYVALE, Calif., March 16, 2016 (GLOBE NEWSWIRE) -- Intuitive Surgical, Inc. (Nasdaq:ISRG), the global leader in robotic-assisted minimally invasive surgery, today announced that the United States Food and Drug Administration has provided 510(k) clearance for the company’s da Vinci® Xi®  Single-Site instruments and accessories.

Intuitive Surgical’s Single-Site technology enables surgeons to operate through a single incision in the patient’s umbilicus during cholecystectomy, benign hysterectomy and salpingo-oophorectomy procedures.

“The da Vinci Xi was designed to seamlessly integrate advanced and future technologies and we are extremely pleased to further expand our line of product offerings with the clearance of Single-Site instruments and accessories,” said Sal Brogna, Executive Vice President, Product Operations, Intuitive Surgical. “Single-Site technology adds great versatility to the da Vinci Xi by enabling both single port and multi-port surgery on a single system.”

Since receiving FDA clearance in 2011, Single-Site technology for the da Vinci SiSurgical System has become the most prominent robotic-assisted single-port platform on the market. The da Vinci Xi Surgical System improves upon this platform with new technology, access, and functionality, including:

  • Improved Vision: The da Vinci Xi 8 mm endoscope provides the surgeon a brighter, higher resolution view of the surgical field with integrated Firefly® fluorescence imaging to highlight specific tissues such as vessels and bile ducts.
  • Easier Setup: A single-fin attachment system makes docking easier and faster with added Single-Site features like guided setup to improve OR team usability.
  • Great Patient Access:  The boom-mounted architecture of the da Vinci Xi Surgical System improves access around the patient with redesigned arms to provide greater range of motion.

The Single-Site product is immediately available for order, with rollout occurring in Q1 of 2016.

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, Calif., is the global leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci® Surgical System.

About the da Vinci Surgical System

There are several models of the da Vinci Surgical System. The da Vinci Surgical Systems are designed to help surgeons perform minimally invasive surgery. da Vinci Systems are not programmed to perform surgery on their own. Instead, the procedure is performed entirely by a surgeon who controls the system. da Vinci Systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

Important Safety Information

Serious complications may occur in any surgery, including da Vinci Surgery, up to and including death. Risks include, but are not limited to, injury to tissues and organs and conversion to other surgical techniques. 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. Individual surgical results may vary. Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci Surgery. Patients should talk to their doctors 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. Please also refer to for Important Safety Information.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding regulatory clearances to market the da Vinci Xi System around the world. 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. These forward-looking statements should, therefore, be considered in light of various important factors, including those under the heading "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2015, 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 using words such as "estimates," "projects," "believes," "anticipates," "plans," "expects," "intends," "may," "will," "could," "should," "would," "targeted" and similar words and 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, except as required by law.

© 2016 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.

CONTACT: Intuitive Surgical, Inc. (Nasdaq:ISRG)
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