Intuitive Surgical Expands Single-Port Capabilities with FDA-Cleared Stapler

Intuitive Surgical has announced FDA clearance for its SP Sureform 45 stapler, specifically designed for use with the da Vinci SP single-port robotic surgery system. The stapler, the first of its kind for single-port robotic procedures, incorporates Smartfire technology from Intuitive’s multi-port platforms to optimize tissue compression and improve staple line integrity.

This clearance marks a pivotal moment for Intuitive’s single-port strategy, enabling broader commercial efforts across FDA-approved indications, including thoracoscopic and colorectal surgeries. The da Vinci SP system, first introduced in 2018, uses a single incision to access narrow surgical spaces, complementing Intuitive’s existing multi-port robots.

By the end of 2023, 273 da Vinci SP systems had been installed. The stapler’s approval is expected to accelerate adoption of the SP platform, with thoracic, colorectal, and urology procedures now covered. Meanwhile, competitors like Vicarious Surgical continue development in the single-port space, though face delays in clinical progress.

22-04-2025