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Intuitive Receives FDA Clearance for SP SureForm 45 Stapler for Use with da Vinci SP Surgical System

Intuitive has announced that the U.S. Food and Drug Administration (FDA) has cleared its fully wristed SP SureForm 45 stapler for use with the da Vinci SP surgical system in thoracic, colorectal, and urologic procedures.

Similar to its multiport counterparts, the SP SureForm 45 incorporates SmartFire technology, which continuously monitors tissue compression before and during firing. This real-time feedback optimizes performance, helping surgeons maintain staple line integrity and minimize tissue damage across varying tissue thicknesses.

“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. This kind of control can help save valuable operating time,” said Intuitive Chief Medical Officer Myriam Curet, M.D.

The da Vinci SP system utilizes robotic-assisted technology, empowering surgeons to perform procedures with advanced techniques that can lead to quicker patient recovery and less postoperative pain. These techniques are enabled by the system’s ability to control up to three wristed instruments and an HD 3D camera through a single port, allowing for internal triangulation and reducing the risk of external instrument collisions in tight surgical spaces.

The da Vinci SP system is authorized for a wide range of procedures in Europe, Japan, Korea, and Taiwan. In the United States, the FDA has approved its use in urology, transoral otolaryngology, colorectal, and thoracic surgeries. The SP SureForm 45 stapler is specifically cleared for thoracic, colorectal, and urologic applications in the U.S., but not for transoral otolaryngology.

The da Vinci SP is part of Intuitive’s broader portfolio of surgical systems, which includes the multiport da Vinci Xi, X, and the newly introduced fifth-generation da Vinci 5 systems.


Source: Intuitive Surgical, Inc.

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