Intuitive received FDA clearance for its fully wristed SP SureForm 45 stapler.
The stapler works with the surgical robotics leader’s da Vinci SP surgical system in thoracic, colorectal and urologic procedures. SP SureForm 45 features SmartFire technology, which continuously monitors tissue compression before and during firing. Its real-time optimization helps to enhance staple line integrity and reduce the risk of tissue damage across varying thicknesses, Intuitive says.
Related: Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment
da Vinci SP provides surgeons with robotic-assisted technology to perform procedures with innovative approaches. Surgeons have control of up to three wristed instruments and a high-definition (HD), 3D camera, making these approaches possible. These instruments, which include the SureForm 45 stapler, and camera enter through a single access point. They triangulate inside the body to help eliminate external instrument collisions.
Intuitive’s da Vinci SP has approval for a variety of procedures across Europe, Japan, Korea and Taiwan. It has U.S. FDA approval for urology, transoral otolaryngology, colorectal and thoracic procedures. The new stapler has clearance for all of those U.S. procedures excluding transoral otolaryngology.
“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,” said Intuitive Chief Medical Officer Dr. Myriam Curet.
