Intuitive Surgical receives FDA clearance for gynaecological laparoscopic procedures

Sunnyvale 26 April 2005FDA clearance has been granted for use of Intuitive Surgical Inc.'s da Vinci Surgical System to perform gynaecological laparoscopic procedures. The clearance allows United States surgeons to use the da Vinci System in procedures such as hysterectomy or removal of the uterus and myomectomy or 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, stated: "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 gynaecological procedures." Lonnie 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 & Gynaecology, Mayo Clinic in 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 gynaecologic cancers."

Arnold Advincula, M.D., Director of the Chronic Pelvic Pain Programme 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", Dr. Advincula stated. "The robotic technique will enable more surgeons to offer a minimally invasive approach to their patients", he added.

The da Vinci Surgical System is a 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 Instruments and 3D camera. 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.

Intuitive Surgical Inc. is a global expert in robotic-assisted, minimally invasive surgery (MIS). The company's da Vinci 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 gynaecological 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 da Vinci news can be found in the VMW April 2005 article Iowa baby to receive life-saving robotic surgery by University of Iowa doctors using da Vinci.

Leslie Versweyveld

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