SHERIDAN, WYOMING – May 7, 2025 – Intuitive, a global leader in minimally invasive care and robotic-assisted surgery, has announced that its SureForm 45 stapler has received FDA clearance for use with the da Vinci SP surgical system. The stapler is now approved for thoracic, colorectal, and urology procedures, marking a significant milestone in robotic surgical technology.
This advancement allows surgeons to use the SureForm 45 stapler in single-port robotic surgeries, providing enhanced control and improved procedural efficiency. The FDA's clearance represents a major leap forward for Intuitive's continued innovation in surgical robotics and its commitment to reducing patient recovery times and enhancing surgical outcomes.
Advanced Technology for Enhanced Surgical Precision
The SureForm 45 stapler integrates with Intuitive’s da Vinci SP surgical system, enabling surgeons to perform minimally invasive procedures with unprecedented precision. Unlike traditional multi-port surgical systems, the da Vinci SP system operates through a single access point, reducing the need for multiple incisions. This single-port approach is particularly beneficial for complex surgeries in confined spaces, as it minimizes external instrument collisions and improves operational access.
Key features of the SureForm 45 stapler include:
- SmartFire Technology: Continuously monitors tissue compression during the firing process, optimizing staple line integrity and reducing tissue damage.
- Wristed Technology: Provides the surgeon with advanced control through the da Vinci SP console, ensuring precise stapling even in challenging surgical environments.
- Real-Time Optimization: Improves surgical efficiency and safety by optimizing tissue compression dynamically throughout the procedure.
Myriam Curet, M.D., Chief Medical Officer at Intuitive, stated, "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."
The da Vinci SP System: Redefining Robotic Surgery
The da Vinci SP system provides surgeons with unparalleled control over minimally invasive procedures. It utilizes up to three wristed instruments and a high-definition 3D camera, offering superior visualization and precise manipulation inside the body. This advanced robotic platform facilitates faster recovery times, reduced postoperative pain, and enhanced patient outcomes.
The system's ability to perform through a single port is especially crucial in the fields of thoracic, colorectal, and urology procedures, where space is limited, and surgical precision is critical. Surgeons can now perform these complex surgeries with more confidence, knowing that the SureForm 45 stapler's innovative design and technology support their efforts for optimal results.
Broadening Applications and Global Reach
In addition to the FDA clearance in the United States, the da Vinci SP system is already approved for use across a variety of surgical procedures in key global markets, including Europe, Japan, Korea, and Taiwan. The SP SureForm 45 stapler has similarly received international attention, with approval for use in thoracic, colorectal, and urology procedures.
While the system has not yet received clearance for transoral otolaryngology procedures in the U.S., the potential applications of the SureForm 45 stapler continue to expand, offering surgeons the tools they need for a broader range of complex surgeries.
Looking Ahead: Enhancing Surgical Excellence
The introduction of the SureForm 45 stapler for single-port robotic surgery aligns with Intuitive’s ongoing mission to advance minimally invasive surgery. By integrating cutting-edge technology with intuitive design, Intuitive is enhancing surgical capabilities and helping physicians deliver better outcomes for their patients.
For more information about the SureForm 45 stapler and the da Vinci SP surgical system, visit Intuitive's website.