Intuitive Surgical Receives FDA Clearance for Gynecological Laparoscopic Procedures
SUNNYVALE, CA, Apr 26, 2005 (MARKET WIRE via COMTEX) -- Intuitive Surgical, Inc. (NASDAQ: ISRG), the global leader in robotic-assisted, minimally invasive surgery, today announced that FDA clearance has been granted for use of the da Vinci(R) Surgical System to perform gynecological laparoscopic procedures.
The clearance allows U.S. surgeons to use the da Vinci System in procedures such as hysterectomy (removal of the uterus) and myomectomy (removal of uterine fibroids). These procedures are usually performed through large abdominal incisions resulting in significant postoperative convalescence, pain, blood loss and scarring. With the use of the da Vinci System, patients may benefit from a faster recovery time, a shorter hospital stay, less pain, less scarring and a quicker return to normal activities.
Commenting on the clearance, Lonnie Smith, President and CEO of Intuitive Surgical, said, "We are pleased with the FDA's most recent clearance for the da Vinci Surgical System. This is a significant first step towards our goal of standardizing a broad range of minimally invasive gynecological procedures." Smith cautioned, "We consider this an early-stage opportunity. Developing this market will require working closely with key surgeons to establish teachable and repeatable clinical pathways for other surgeons to follow."
Javier F. Magrina, M.D., Chair, Department of Obstetrics & Gynecology, Mayo Clinic -- Scottsdale, observed that the da Vinci System will have a positive impact in the area of women's health. "Robotic surgery is an upgraded form of minimally invasive surgery and is associated with major patient benefits. The robotic operation is more precise than conventional surgery and it allows a patient to return to normal activities much more quickly. We have also noted a reduced use of pain medications after robotic surgery, indicating less tissue trauma. Robotic surgery is especially useful in performing hysterectomies, removing fibroids for uterine preservation, correcting vaginal prolapse, and for the treatment of gynecologic cancers."
Arnold Advincula, M.D., Director of the Chronic Pelvic Pain Program at the University of Michigan, a National Center of Excellence in Women's Health, agreed that patients would benefit from this advanced surgical approach. "In our surgical series of over 45 myomectomies published in the November 2004 issue of the Journal of the American Association of Gynecologic Laparoscopy, patients successfully underwent uterine-preserving surgery and recovered much faster. Patients are leaving the hospital the same day of surgery," Advincula said. "The robotic technique will enable more surgeons to offer a minimally invasive approach to their patients," he added.
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. (NASDAQ: ISRG) is the global leader in robotic-assisted, minimally invasive surgery (MIS). The Company's da Vinci(R) Surgical System offers physicians superior visualization, enhanced dexterity, greater precision and ergonomic comfort for the optimal performance of MIS. In addition to surgery for the treatment of prostate cancer, the da Vinci System can be used in general gynecological and urological procedures, minimally invasive cardiac procedures and in complex abdominal surgery. Intuitive Surgical has nearly 300 da Vinci Systems installed in hospitals worldwide. More information is available at www.intuitivesurgical.com and www.davinciprostatectomy.com.
Intuitive Surgical -- Taking surgical precision beyond the limits of the human hand(TM)
About the da Vinci(R) Surgical System
The da Vinci Surgical System is the world's only robotic surgical platform designed to enable physicians to perform complex procedures through a series of 1-2 cm incisions. The da Vinci System offers superior visualization, enhanced dexterity, greater precision and ergonomic comfort for the optimal performance of minimally invasive surgery. The da Vinci System consists of an ergonomically designed surgeon's console, which is linked to a patient-side surgical cart featuring four robotic arms that position and maneuver the System's proprietary EndoWrist(R) Instruments and 3D camera. A. The da Vinci System scales, filters and seamlessly translates the surgeon's hand movements into precise movements of the EndoWrist instruments. By allowing physicians to perform complex surgery in a manner never before experienced, Intuitive Surgical believes that the da Vinci System is driving new standards in patient care.
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 the following: timing and success of product development and market acceptance of developed products; regulatory approvals, clearances and restrictions; guidelines and recommendations in the health care and patient communities; intellectual property positions and litigation; competition in the medical device industry and in the specific markets of surgery in which Intuitive Surgical operates; and unanticipated manufacturing disruptions, delays in regulatory approvals of new manufacturing facilities or the inability to meet demand for products. Words such as "estimate," "project," "plan," "intend," "expect," "anticipate," "believe" and similar 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 to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
Intuitive(R), da Vinci(R), InSite(R) and EndoWrist(R) are registered trademarks of Intuitive Surgical, Inc. www.intuitivesurgical.com
Intuitive Surgical, Inc
SOURCE: Intuitive Surgical, Inc.