Intuitive's SP SureForm 45 stapler was cleared by the U.S. Food and Drug Administration for use with the da Vinci SP surgical system in thoracic, colorectal, and urologic procedures. The clearance introduces the first stapler specifically designed for single-port robotic-assisted surgery.

The SP SureForm 45 incorporates SmartFire technology, which continuously monitors tissue compression prior to and during staple firing, according to a press release from Intuitive. This real-time adjustment is intended to enhance staple-line integrity and minimize tissue trauma across variable tissue thicknesses. As with Intuitive’s multiport staplers, this device enables the surgeon to operate the stapler directly from the console, potentially reducing reliance on a bedside assistant and improving intraoperative efficiency.

The da Vinci SP platform allows access through a single incision using a combination of a three-dimensional, high-definition endoscope and up to three wristed instruments. The design supports internal triangulation of instruments, which may reduce the risk of external collisions in narrow surgical fields.

In the United States, the da Vinci SP system is U.S. Food and Drug Administration–cleared for urology, thoracic, colorectal, and transoral otolaryngology procedures. The newly cleared stapler is not indicated for use in transoral otolaryngology. The platform is also cleared in Europe, Japan, Korea, and Taiwan for various surgical indications.

The SP SureForm 45 adds to Intuitive’s lineup of stapling instruments, which also includes models compatible with the company’s multiport da Vinci 5, Xi, and X surgical systems. 

Product use, indications, and safety information are available on the manufacturer’s website. Disclosures related to the device clearance were not provided in the company announcement.