Intuitive wins FDA Clearance for Single-port Robotic Surgery Stapler

Intuitive wins FDA Clearance for Single-port Robotic Surgery Stapler

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.”

Medigy Insights

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.


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