Intuitive Surgical (ISRG) Reports 510(k) Clearance for da Vinci Xi EndoWrist Stapler 30 Instruments, Reloads

March 14, 2016 8:34 AM EDT

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Intuitive Surgical, Inc. (Nasdaq: ISRG), the global leader in robotic-assisted minimally invasive surgery, today announced that the United States Food and Drug Administration has provided 510(k) clearance for the company’s da Vinci® Xi™ EndoWrist Stapler 30 (30mm) 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 Vinci stapling portfolio,” said Sal Brogna, Executive Vice President, Product Operations, Intuitive Surgical. “This clearance further underscores the progress we’ve made in developing a broad suite of tools and resources for surgeons spanning several specialties, including thoracic and general surgery.”

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 Vinci surgeon 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.

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