FDA Clears Integrated Table Motion For da Vinci Surgical System
Companies to deliver operating room table engineered to move in sync with da Vinci Xi Surgical System
Sunnyvale, CA – Intuitive Surgical, Inc. (NASDAQ: ISRG) and Trumpf Medical, a division of Hill-Rom Holdings, Inc. (NYSE: HRC), today announced that the Food and Drug Administration has cleared Intuitive Surgical’s 510 (k) to offer Integrated Table Motion for the da Vinci Xi Surgical System in the United States.
Integrated Table Motion seamlessly combines the da Vinci Xi, Intuitive Surgical’s latest robotic-assisted surgical system, and Trumpf Medical’s advanced operating table, the TruSystem® 7000dV, to allow surgeons and anesthesiologists the ability to make a comprehensive range of table adjustments easily and efficiently during a surgical procedure.
In a first-of-its-kind product offering, Integrated Table Motion delivers surgical teams the real-time ability to reposition the operating table with the surgical robotic arms docked. This surgical advancement addresses the need for operating room efficiency by maximizing access, exposure and reach during a robotic-assisted surgical procedure.
Integrated Table Motion also gives operating room (OR) teams, while conducting robot-assisted surgery, the ability to leverage the TruSystem 7000dv operating table’s capabilities to:
- Optimally position the table so that gravity exposes anatomy during multi-quadrant da Vinci System procedures;
- Maximize reach and access to target anatomy – enabling surgeons to interact with tissue at an ideal working angle; and
- Reposition the table during the procedure to enhance anesthesiologists’ care of the patient.
“Integrated Table Motion is another significant advancement in our effort to deliver a first-rate product and service ecosystem to help surgeons navigate complex procedures,” says Myriam Curet, Senior Vice President and Chief Medical Officer, Intuitive Surgical. “This product allows surgeons to maximize reach and access throughout the surgical process, enabling more efficient interaction with tissue and target anatomy.”
The da Vinci Surgical System and TruSystem® 7000dV table are synchronized in movement — the table’s positioning is relayed to the da Vinci Surgical System and is met with an intuitive adjustment of its instrument arms, boom and endoscope to maintain consistent orientation to the patient’s anatomy. Intuitive Surgical and Trumpf Medical spent five years working together to make the integration of the two systems possible.
“Our collaboration demonstrates the true power of partnership,” says Dirk Ehlers, President of Hill-Rom Surgical Solutions. “When innovative, focused companies like Intuitive Surgical and Trumpf Medical come together to bring highly advanced medical technologies together in a true spirit of cooperation, good things can happen for patients and their caregivers. We are proud of this new, enabling capability in minimally invasive surgery.”
Over the next several months, Integrated Table Motion will be available for sale in the United States and introduced to hospitals around the country.
“Managing any complex surgical procedure requires intricate coordination and orchestration. Adding Integrated Table Motion to our surgical system will be a tremendous leap forward in helping our team streamline and simplify our workflow during surgery,” said Jill Hauswirth, RN, Director of Surgical Services for Crouse Hospital, New York. “I am proud that our hospital will be one of the first to implement the Integrated Table Motion system and look forward to the response from our physicians.”
Integrated Table Motion for the da Vinci Xi Surgical System launched in Europe after receiving CE marking in June 2015. Intuitive Surgical and Trumpf Medical are seeking further clearances to market Integrated Table Motion around the world.
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.
About Hill-Rom Holdings, Inc.
Hill-Rom is a leading global medical technology company with approximately 10,000 employees worldwide. We partner with health care providers in more than 100 countries by focusing on patient care solutions that improve clinical and economic outcomes in five core areas: Advancing Mobility, Wound Care and Prevention, Clinical Workflow, Surgical Safety and Efficiency, and Respiratory Health. Around the world, Hill-Rom’s people, products, and programs work towards one mission: Enhancing outcomes for patients and their caregivers.
About Trumpf Medical
Trumpf Medical, a division of Hill-Rom Holdings, Inc., develops and produces modern medical equipment for the OR, intensive care unit, and associated clinical areas, providing hospital staff with the best possible support in delivering efficient and safe care to their patients. Its product range includes flexible and modular OR tables, special purpose furnishings for OR settings and the intensive care unit, as well as innovative OR lighting technologies and camera systems.
TruSystem is a registered trademark of Trumpf GmbH + Co. KG
Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy 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. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
da Vinci Table Motion is intended to allow the surgical staff to reposition the patient by adjusting the table without undocking the da Vinci Xi Surgical System (Model IS4000) during urologic surgical procedures, general laparoscopic surgical procedures, and gynecologic laparoscopic surgical procedures. It is designed to be used with a compatible operating room OR table.
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 doctor 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.
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 Xi 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, 2014 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.
SOURCE: Intuitive Surgical
