FDA Clears First Stapler for Single-Port Robotic Surgery with da Vinci SP System
核心洞察
Intuitive Surgical received FDA 510(k) clearance for the SureForm 45 (搜索) stapler, marking the first stapler designed specifically for single-port robotic surgery in the United States.
The fully-wristed stapler features SmartFire (搜索) technology that continuously monitors tissue compression before and during firing, helping surgeons enhance staple line integrity and reduce tissue damage risk.
The device is cleared for use with the da Vinci SP (搜索) surgical system in urologic, thoracic, and colorectal procedures, allowing surgeons greater control without relying on assistants.
Intuitive Surgical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the SureForm 45 (搜索) stapler for use with the da Vinci SP (搜索) surgical system. This milestone represents the first clearance of a stapler specifically designed for single-port robotic surgery in the United States.
The newly approved device is cleared for use in urologic, thoracic, and colorectal procedures, expanding the capabilities of Intuitive's single-port robotic platform.
Enhanced Surgical Control and Efficiency
The SureForm 45 (搜索) stapler is fully wristed and integrates with the da Vinci SP (搜索) system, allowing surgeons to maintain complete control of procedures directly from the surgical console.
"Being able to use a SureForm 45 (搜索) 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 Myriam Curet, MD, Chief Medical Officer for Intuitive.
Advanced Technology for Tissue Management
Like Intuitive's staplers for multiport procedures, the SP SureForm 45 (搜索) features SmartFire (搜索) technology, which continuously monitors tissue compression before and during firing. This real-time optimization helps surgeons enhance staple line integrity and reduce the risk of tissue damage across varying tissue thicknesses.
The technology represents a significant advancement in single-port robotic surgery, potentially improving surgical outcomes and efficiency.
The da Vinci SP Surgical System
The SureForm 45 (搜索) stapler complements Intuitive's da Vinci SP (搜索) surgical system, which is designed specifically for single-port procedures. The system features three multi-jointed, wristed instruments and a high-definition, 3D camera, all triangulated to prevent external instrument collisions during procedures.
The da Vinci SP (搜索) system was initially cleared for urological surgical procedures in April 2014, with expanded indications in 2023 to include simple prostatectomy and transvesical approaches to simple and radical prostatectomy. The system is currently approved for various surgical procedures in the United States, Europe, Japan, Korea, and Taiwan.
Expanding Robotic Surgery Portfolio
This clearance adds to Intuitive's comprehensive portfolio of robotic platforms, which includes a suite of multiport systems such as the da Vinci 5 (搜索), Xi, and X. The da Vinci 5, Intuitive's most recent generation multiport system, received FDA clearance in March 2024.
The addition of the SureForm 45 (搜索) stapler to the da Vinci SP (搜索) system represents Intuitive's ongoing commitment to advancing minimally invasive surgery through innovative technology. By providing surgeons with more control and precision during single-port procedures, the company aims to improve surgical outcomes and efficiency across urologic, thoracic, and colorectal specialties.