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Intuitive Wins FDA Nod for 1st Stapler Designed for Single-Port Robotic Surgery

Intuitive’s SureForm 45 stapler is available for thoracic, colorectal, and urology procedures.

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By: Sam Brusco

Associate Editor

The da Vinci SP (single-port) surgical robotic system. Photo: Intuitive.

Intuitive has received U.S. Food and Drug Administration (FDA) clearance for its fully wristed SP (single-port) SureForm 25 stapler for use with its da Vinci SP in thoracic, colorectal, and urologic procedures.

The SP SureForm 45 features the company’s SmartFire technology, which continuously monitors tissue compression before and during fitting. The real-time optimization helps enhance staple line integrity and reduce risk of tissue damage across varying thicknesses.

da Vinci SP allows surgeons to perform procedures with innovative approaches that help promote faster recovery and reduce post-op pain. The approaches are made possible by control of up to three wristed instruments and an HD 3D camera.

The instruments (including the SureForm 45 stapler) and camera enter through a single access point and triangulate inside the body. This helps remove external instrument collisions that can happen in small surgical workspaces.

“Being able to use a SureForm 45 stapler in single-port robotic surgery helps provide surgeons with more control of their procedures from the da Vinci surgeon console, without the need to rely on an assistant to fire a stapler,” said Intuitive chief medical officer Myriam Curet, MD. “This kind of control can help save valuable operating time.”

da Vinci SP is approved for a variety of surgical procedures in Europe, Japan, Korea, and Taiwan. In the U.S., the FDA has cleared the da Vinci SP surgical system for urology, transoral otolaryngology, colorectal, and thoracic procedures.

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