Intuitive Surgical wins FDA 510(k) clearance for new EndoWrist stapler

by Brad Perriello for MassDevice

Intuitive Surgical (NSDQ:ISRG) said today that the FDA cleared a new EndoWrist stapler for its next-generation da Vinci Xi root-assisted surgery device.

The 510(k) clearance for the EndoWrist 30 device covers straight and curved-tip staplers and 30mm reloads, the Sunnyvale, Calif.-based company said.

“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,” operations EVP Sal Brogna said in prepared remarks. “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.”

Intuitive said it plans to begin the EndoWrist Stapler 30 rollout this month.

ISRG shares have gained 3.0% since Feb. 29, when the company touted results from a study evaluating robotic-assisted hysterectomies, showing lower complication rates for procedures using the da Vinci device compared with open and laparoscopic surgeries. The stock closed March 11 at $580.45, up 1.2% on the day.

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