Dive Brief:
- Intuitive said Thursday the Food and Drug Administration has cleared a stapler for use with its single-port robotic surgery system.
- The device, which Intuitive said is the first stapler designed for single-port robotic surgery, shares features found in the company’s multi-port products to reduce the risk of tissue damage.
- CFO Jamie Samath said in January that the stapler nod would trigger the start of “broad commercial efforts” for the single-port system in two indications recently authorized by the FDA.
Dive Insight:
Intuitive began commercializing the da Vinci SP single-port surgical robot in 2018 and had installed 273 systems by the end of last year. The system accesses the body through a single incision, unlike Intuitive’s multi-port robots. Intuitive designed da Vinci SP to complement its multi-port robots by enabling surgeons to access narrow workspaces.
The FDA cleared the single-port device for use in general thoracoscopic surgical procedures in July and added colorectal surgeries to the list of authorized indications in November. Samath has repeatedly said the stapler is key to unlocking the indications.
Talking on an earnings call in July, the CFO said the thoracic single-port procedure “is optimal when you have a stapler.” Intuitive planned to work with early adopters on the thoracic indication, Samath said, but saw the stapler launch as the point it could “more robustly drive adoption.”
Samath said colorectal use will require the stapler on the July call and repeated the message about both indications in January.
The FDA cleared the SP Sureform 45 stapler last month, but Intuitive waited until this week to announce the decision. The clearance covers a device that features the Smartfire technology used in Intuitive’s multi-port staplers. Smartfire monitors tissue compression before and during the firing of a staple, and is designed to enhance staple line integrity and reduce the risk of tissue damage, Intuitive said.
With clearance for the stapler in thoracic, colorectal and urology procedures, Intuitive is positioned to potentially drive adoption of da Vinci SP in the indications. However, the extent of the opportunity is unclear. Samath said in July that Intuitive’s multi-port robots are “already relatively highly penetrated” in the U.S. thoracic market, “so really the question then is [the] relative value of SP compared to Xi.”
Other companies are targeting the single-port space. Vicarious Surgical is developing a single-port robot for use in abdominal procedures, but recently delayed its planned de novo submission to late 2026 after supply chain challenges pushed back the start of a clinical trial.
