U.S. FDA clears first stapler designed for single-port robotic surgeryApril 10, 2025 at 09:15 AM EDT
SUNNYVALE, Calif., April 10, 2025 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that the U.S. Food & Drug Administration (FDA) cleared the company’s fully wristed SP SureForm 45 stapler for use with its da Vinci SP surgical system in thoracic, colorectal, and urologic procedures. Like its multiport counterparts, the SP SureForm 45 features SmartFire technology, which continuously monitors tissue compression before and during firing. This real-time optimization helps surgeons enhance staple line integrity and reduce the risk of tissue damage across varying thicknesses. “Being able to use a SureForm 45 stapler in single-port robotic surgery helps provide surgeons with more control of their procedures from the da Vinci surgeon console, without the need to rely on an assistant to fire a stapler. This kind of control can help save valuable operating time,” said Intuitive Chief Medical Officer Myriam Curet, M.D. The da Vinci SP system provides surgeons with robotic-assisted technology, enabling them to perform procedures with innovative approaches that help promote faster patient recovery and reduce postoperative pain. These innovative surgical approaches are made possible by surgeon control of up to three wristed instruments and a high definition (HD), three-dimensional (3D) camera. The instruments—including the SureForm 45 stapler—–and camera enter through a single access point and triangulate inside the body, helping eliminate external instrument collisions that can occur in small surgical workspaces. The da Vinci SP surgical system is approved for use across a variety of surgical procedures in Europe, Japan, Korea, and Taiwan. In the U.S., the FDA has cleared the da Vinci SP surgical system for urology, transoral otolaryngology, colorectal, and thoracic procedures. The SP SureForm 45 stapler has received FDA clearance for thoracic, colorectal, and urology procedures, though it is not cleared for transoral otolaryngology procedures. Da Vinci SP is part of Intuitive’s portfolio of surgical systems. The da Vinci 5, Xi, and X are Intuitive’s multi-port surgical systems, now in its fifth generation of innovative technology. Contact Information: Peper Long, Intuitive About Intuitive About da Vinci Surgical Systems For more information, please visit the company’s website at www.intuitive.com. Important Safety Information Forward-Looking Statements Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release and which are based on current expectations and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those risk factors identified under the heading “Risk Factors” in Intuitive’s Annual Report on Form 10-K for the year ended December 31, 2024, as updated by its other filings with the U.S. Securities and Exchange Commission. Intuitive’s actual results may differ materially and adversely from those expressed in any forward-looking statements, and it undertakes no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.
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