The FDA cleared da Vinci SP for use in inguinal hernia repair, cholecystectomy and appendectomy procedures. These clearances add to existing U.S. indications in urology, colorectal, thoracic and transoral procedures. They also mark the second label expansion from the FDA this year, with da Vinci SP picking up clearance for transanal local excision/resection in colorectal procedures in May.
“Da Vinci SP was designed to give surgeons advanced capability through a single port, offering the precision and control needed in narrow or deep anatomical spaces,” said Iman Jeddi, SVP and General Manager, da Vinci Platforms and Product Operations at Intuitive. “This clearance is one part of our innovation pathway for SP. We continue to evolve the platform with new tools and capabilities that help teams pursue less invasive approaches and expand what’s possible with da Vinci SP.”
Intuitive has continued to expand indications for multiple robots this year, with its Ion system earning new FDA nods in October, shortly after the company unveiled the first in a series of new software capabilities for its da Vinci 5 surgical robot platform. The company faces increased competition in the surgical robot space, with Medtronic recently earning the first FDA clearance for its Hugo robot.
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With da Vinci SP, Intuitive enables surgeons to perform procedures through a single incision or natural orifice. This offers enhanced visualization and precision. Its design also supports access to anatomy by allowing surgeons to control up to three multi-jointed instruments and an articulating 3DHD endoscope through one entry point. Those instruments include the fully wristed SP SureForm 45 stapler, which the FDA cleared earlier this year.
da Vinci SP also has regulatory clearance in Europe, Japan and Korea for a range of procedures across a variety of surgical disciplines.
“Advancing da Vinci SP is part of our long-term commitment to helping improve the future of patient care — supporting approaches that are less invasive, reduce recovery time, lower the total cost of care, and create a better experience for patients as they return to their lives,” said Dr. Myriam Curet, EVP and chief medical officer at Intuitive. “As we continue to innovate across our platforms, we remain focused on helping more patients access the benefits of minimally invasive care.”
