Intuitive Surgical Advances Single-Port Robotic Surgery with FDA Clearance for New Stapler

Intuitive Surgical, a leader in robotic-assisted minimally invasive surgery, has received FDA clearance for its SP SureForm 45 stapler, designed specifically for use with the company's da Vinci SP single-port robotic surgery system. This clearance marks a significant milestone in single-port robotic surgery, potentially expanding the application of this advanced technique across multiple surgical specialties.

FDA Clearance and Device Capabilities

The SP SureForm 45 stapler, cleared by the FDA in March 2025, is the first stapler designed for single-port robotic surgery. It has been authorized for use in thoracic, colorectal, and urologic procedures. The device incorporates Intuitive's Smartfire technology, which monitors tissue compression before and during staple firing to enhance staple line integrity and reduce the risk of tissue damage.

Dr. Myriam Curet, Chief Medical Officer at Intuitive, emphasized the benefits of the new stapler: "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."

Expanding Applications for Single-Port Surgery

The clearance of the SP SureForm 45 stapler is expected to trigger broader commercial efforts for the da Vinci SP system in recently authorized indications. Intuitive CFO Jamie Samath had previously indicated that the stapler was key to unlocking the full potential of single-port procedures, particularly in thoracic and colorectal surgeries.

The da Vinci SP system, which Intuitive began commercializing in 2018, allows surgeons to perform procedures through a single incision. By the end of 2024, 273 da Vinci SP systems had been installed globally. The system is designed to complement Intuitive's multi-port robots by enabling access to narrow workspaces.

Competitive Landscape and Future Outlook

While Intuitive continues to advance its single-port technology, other companies are also targeting this space. Vicarious Surgical is developing a single-port robot for abdominal procedures, although they recently delayed their planned de novo submission to late 2026 due to supply chain challenges.

As the field of robotic-assisted surgery evolves, Intuitive is also making strides in other areas. The company recently conducted preclinical studies on the force feedback capabilities of its latest da Vinci 5 robot, set for full commercial launch this year. These studies suggest that force feedback at the surgeon's control console may lead to gentler surgeries, with potential benefits for patient outcomes and recovery times.