Study Results: Robotic-Assisted Benign Hysterectomy Yields Better Results in Clinical Outcomes

SUNNYVALE, Calif., Feb. 29, 2016 -- Intuitive Surgical, Inc. (Nasdaq:ISRG) today announced the published results from a new study¹ titled, “Multicenter analysis comparing robotic, open, laparoscopic and vaginal hysterectomies performed by high volume surgeons for benign indication.”  When evaluating comparable surgeon experience, the study found that women undergoing benign hysterectomies by robotic-assisted surgeons using da Vinci® Surgical Systems had better outcomes and experienced fewer complications compared to conventional abdominal, vaginal and laparoscopic hysterectomies outcomes.²

The study, which was published in the International Journal of Gynecology and Obstetrics, and led by Peter Lim, M.D. at Renown Regional Medical Center in Reno, Nevada, analyzed over 32,000 benign hysterectomy cases and compared the outcomes of high-volume surgeons across the four surgical approaches.  The study compared 30-day outcomes from robotic-assisted hysterectomies performed by high-volume surgeons (≥60 procedures) with data from high-volume surgeons obtained from the Premier Perspective database for abdominal, vaginal, and laparoscopic hysterectomies. The data evaluated included: 2,300 robotic-assisted, 9,745 abdominal, 8,121 vaginal and 11,952 laparoscopic hysterectomies.

“It’s long been clear that minimally invasive hysterectomy can help reduce complications and speed recovery.  But past studies comparing open and minimally invasive approaches compared less experienced robotic-assisted surgeons with colleagues in other approaches,” said Peter Lim, M.D., FACOG, The Center of Hope, Renown Regional Medical Center, Nevada.  “This study is designed to compare only the outcomes of similarly experienced surgeons, regardless of surgical approach, which provides a much more accurate picture of comparative effectiveness.”

The study found subjects undergoing robotic assisted procedures with Intuitive Surgical’s da Vinci robotic surgical systems experienced significantly fewer intraoperative complications than patients who underwent abdominal or vaginal procedures and fewer than those who had a laparoscopic procedure.  These better outcomes were observed despite the increased complexity of patients in the robotic-assisted group.   

“Women in the robotic-assisted group had higher rates of obesity, adhesions and large uterus, suggesting that the robotic technology actually enables surgeons to perform surgery on more complex cases,” said Lim.  “This study gives women and the surgeons who care for them important insights to inform their decision making.”

“This study provides compelling and valuable evidence on the advantages of robotic-assisted benign hysterectomy,” said Myriam Curet, M.D., Senior Vice President, Chief Medical Officer at Intuitive Surgical.  “For women undergoing these procedures, the benefits of robotic-assisted surgery shown in this study carry real and tangible results for their recovery and return to everyday life.”

¹ Intuitive Surgical Inc. provided funding for independent research and editorial support.

² Lim PC, Crane JT, English EJ, Farnam RW, Garza DM, Winter ML, Rozeboom JL. Multicenter analysis comparing robotic, open, laparoscopic, and vaginal hysterectomies performed by high-volume surgeons for benign indications. International Journal of Gynecology and Obstetrics. 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 www.daVinciSurgery.com/Safety 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. 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.

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