Intuitive Surgical, headquartered in Calif, has received CE Mark for its new da Vinci X Surgical System.
From press release:
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.
Intuitive Surgical, a global technology leader in robotic-assisted, minimally invasive surgery, announced today that its new da Vinci X Surgical System received CE Mark approval in Europe. 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.
The launch of the da Vinci X System underscores Intuitive’s commitment to meeting customers’ needs with a strong value-oriented portfolio of cost-appropriate technologies and an array of financing options.
“Over the past 21 years, Intuitive Surgical pioneered robotic-assisted surgery and we continue to lead the way in developing and bringing to market innovative technologies, outcomes-focused products and value-oriented solutions,” said Dr. Gary Guthart, CEO of Intuitive Surgical. “Our surgeon, hospital and healthcare customers around the world told us that robotic-assisted surgery matters for their programs and their patients while underscoring the importance of providing choice from a clinical, technological and cost standpoint. The da Vinci X product offering provides a lower-cost solution to meet the needs of customers who want a choice in price points, while offering access to many of our recent innovations.”
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 consoles 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 for procedures like prostatectomy, partial nephrectomy, hernia repair, benign hysterectomy and sacrocolpopexy, among others. The System features flexible port placement and state-of-the-art 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, highly capable offering that meets – and responds to – our customers’ economic and clinical needs,” said Damien Desmedt, General Manager of Intuitive Surgical in the United Kingdom, Ireland, and Nordic countries. “In the countries we serve around the globe, we know that customers have different needs and wants, and we strive to provide an array of choices to meet their needs today and in the future. The da Vinci X System helps us to continue to do this.”
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.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures, thoracoscopically-assisted cardiotomy procedures, and trans-oral otolaryngology surgical procedures restricted to benign tumors and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures. The System can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The System is indicated for adult and pediatric use (except for trans-oral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment.
The da Vinci X Surgical System is a class 2b CE 0543 marked medical device under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc. Refer to the Instructions For Use before use.
Source: GLOBE NEWSWIRE press release
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