Intuitive Surgical Receives FDA Clearance for Latest da Vinci® Robotic-Assisted Surgical System

SUNNYVALE, Calif., May 30, 2017 -- Intuitive Surgical, a global technology leader in robotic-assisted, minimally invasive surgery, announced today that its new da Vinci X Surgical System received FDA clearance in the United States. The da Vinci X System will provide surgeons and hospitals with access to some of the most advanced robotic-assisted surgery technology at a lower cost. FDA clearance of the da Vinci X System follows CE Mark, which was announced in April.

The da Vinci X Surgical System from Intuitive Surgical

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/a5827d84-70f1-49ee-9aed-7fae5c0ecca2

The launch of the da Vinci X System underscores Intuitive’s commitment to meeting customers’ needs with a strong value-oriented portfolio and an array of financing options.

“This new system enables access to Intuitive’s leading and proven robotic-assisted surgical technology at a lower price point,” said Dr. Gary Guthart, CEO of Intuitive Surgical. “Customers around the globe have different needs from a clinical, cost and technology perspective; Intuitive’s goal is to meet those needs by providing a range of products and solutions: the da Vinci X System helps us continue to do so.”

The da Vinci X System offers surgeons and hospitals access to Intuitive’s portfolio of advanced, innovative robotic-assisted surgical technologies – and its full ecosystem of programs, support, services, and solutions – at a lower price.  The System uses the same vision cart and surgeon console that are found on our flagship product, the da Vinci Xi^® System, enabling our customers the option of adding advanced capabilities, and providing a pathway for upgrading should they choose to do so as their practice and needs grow.

The da Vinci X System enables optimized, focused-quadrant surgery including procedures like prostatectomy, partial nephrectomy, benign hysterectomy and sacrocolpopexy, among others. The System features flexible port placement and 3D digital optics, while incorporating the same advanced instruments and accessories as Intuitive’s flagship system. The new system drives operational efficiencies through set-up technology that uses voice and laser guidance, drape design that simplifies surgery prep, and a lightweight, fully integrated endoscope.

“The da Vinci X System is a value-oriented option for hospitals that are just starting their robotic-assisted surgical program and for our existing customers who want to expand their existing robotics programs,” said Henry Charlton, Senior Vice President of U.S. Sales.  “As customers’ needs grow, the da Vinci X System can grow with them.  The da Vinci X System enables our customers to take immediate advantage of Intuitive’s full ecosystem of support and services.”

The da Vinci X System will be available for sale in the U.S. later this year.

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, Calif., is a global technology 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.

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 X 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, 2016, 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.

PN1037898-US Rev A 5/2017

Global Public Affairs
Intuitive Surgical
Email: [email protected]
U.S. Tel: +1 408.523.7337