Intuitive Surgical Announces U.S. Clearance for da Vinci Xi EndoWrist Stapler 30 Instruments and Reloads
Availability of the Stapler 30 for the da Vinci Xi Surgical System expands the company’s EndoWrist Stapler portfolio through the offering of new curved and straight tip instruments and four reloads. With General Surgery, Thoracic, Gynecologic and Urologic surgery indications, the Stapler 30 Curved-Tip instrument provides enhanced placement and visualization around tenuous vasculature. The Stapler 30 instruments and reloads — ranging from gray (0.75mm closed) to green (2.0mm closed) — provide a robust offering of 30mm stapling options for the da Vinci Xi Surgical System.
“Combined with the da Vinci Xi Surgical System’s 3DHD vision, access, and surgeon control and autonomy, the EndoWrist Stapler 30 naturally expands the da
The da Vinci Xi Surgical System design enables control of stapling from the surgeon console, creating a more direct relationship between clinical decision-making and instrument action. Other features include:
- Surgeon Control and
Autonomy: Places control of the stapler directly in the hands of the surgeon. Positioning, grip, clamp and fire are fully controlled by the surgeon through the da Vincisurgeon console.
- Fully Wristed Articulation: The EndoWrist Stapler has the greatest side-to-side articulation currently available, with a range of 108° total side-to-side. The EndoWrist Stapler articulates through a range of 54° total up-and-down, providing a fully-wristed cone of articulation.
- SmartClamp Feedback: Reduces the guesswork associated with conventional, handheld stapling by detecting whether the jaws can adequately close on the target tissue for the given staple height.
The Stapler 30 product is immediately available for order, with rollout occurring in Q1 of 2016.
About the da
There are several models of the da
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.
The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
Important Safety Information
Serious complications may occur in any surgery, including da
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
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