Medical Science
Intuitive Surgical Gains FDA Approval for Stapler in Single-Port Robotic Surgery
2025-04-11

In a recent announcement, Intuitive Surgical revealed that the U.S. Food and Drug Administration (FDA) has approved a specialized stapling device designed exclusively for its single-port robotic surgery system. This development is set to expand the capabilities of minimally invasive surgeries by reducing tissue damage risks. CFO Jamie Samath emphasized that this approval would initiate broader commercial efforts for the single-port system across two newly authorized surgical indications.

A Breakthrough in Single-Port Robotic Surgery

Since 2018, Intuitive Surgical has been progressively integrating its da Vinci SP single-port surgical robot into medical practice. By the end of last year, they had successfully installed 273 systems worldwide. Unlike traditional multi-port robots, the da Vinci SP accesses the body through a single incision, enabling surgeons to navigate narrow anatomical spaces with greater precision. The FDA granted clearance for this device’s use in general thoracoscopic procedures in July and subsequently added colorectal surgeries in November.

This advancement hinges on the SP Sureform 45 stapler, equipped with Smartfire technology. Smartfire enhances staple line integrity by monitoring tissue compression both before and during the stapling process, thereby minimizing the risk of tissue damage. Intuitive Surgical waited until this week to publicly announce the FDA's approval, signifying their readiness to drive adoption of the da Vinci SP system in thoracic, colorectal, and urology procedures.

From a competitive standpoint, other companies are also venturing into the single-port market. Vicarious Surgical, for instance, is developing a similar robot for abdominal procedures but has faced delays due to supply chain challenges.

Implications for the Future of Robotic Surgery

As a journalist covering advancements in medical technology, this milestone by Intuitive Surgical highlights the rapid evolution in robotic-assisted surgeries. It underscores the importance of innovation in enhancing patient safety and expanding surgical possibilities. While the potential impact on market penetration remains uncertain, especially compared to existing multi-port systems, the integration of advanced features like Smartfire technology positions Intuitive at the forefront of this burgeoning field. For readers, this news signifies a promising step towards more efficient and safer surgical interventions, setting a benchmark for future developments in medical robotics.

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