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U.S. FDA clears first stapler designed for single-port robotic surgery
ISRGIntuitive(ISRG) GlobeNewswire·2025-04-10 13:15

Core Insights - Intuitive has received FDA clearance for its SP SureForm 45 stapler, which is designed for use with the da Vinci SP surgical system in thoracic, colorectal, and urology procedures [1][6] - The SP SureForm 45 stapler features SmartFire technology that optimizes tissue compression in real-time, enhancing staple line integrity and minimizing tissue damage [2] - The use of the SureForm 45 stapler in single-port robotic surgery allows surgeons greater control and can reduce operating time [3] Product Features - The da Vinci SP system enables robotic-assisted surgeries with advanced technology that promotes faster patient recovery and less postoperative pain [4] - Surgeons can control up to three wristed instruments and a high-definition 3D camera through a single access point, reducing the risk of external instrument collisions [5] - The da Vinci SP surgical system is approved for various procedures in multiple countries, including the U.S., where it is cleared for urology, transoral otolaryngology, colorectal, and thoracic procedures [6] Company Overview - Intuitive is a leader in minimally invasive care and robotic surgery, with a portfolio that includes the da Vinci surgical system and the Ion endoluminal system [8] - The da Vinci surgical systems are designed to assist surgeons in performing minimally invasive surgeries with high-definition 3D vision and specialized instrumentation [9]