U.S. FDA clears first stapler designed for single-port robotic surgery
Intuitive (ISRG) has received FDA clearance for its SP SureForm 45 stapler, designed specifically for single-port robotic surgery with the da Vinci SP surgical system. The stapler features SmartFire technology that continuously monitors tissue compression, optimizing staple line integrity and reducing tissue damage risks.
The device is cleared for thoracic, colorectal, and urologic procedures in the U.S. The da Vinci SP system enables surgeons to control up to three wristed instruments and an HD 3D camera through a single access point, promoting faster patient recovery and reduced postoperative pain. The system triangulates instruments inside the body, helping prevent external instrument collisions in small surgical spaces.
Intuitive (ISRG) ha ricevuto l'approvazione della FDA per il suo stapler SP SureForm 45, progettato specificamente per la chirurgia robotica a porta singola con il sistema chirurgico da Vinci SP. Lo stapler è dotato della tecnologia SmartFire che monitora continuamente la compressione dei tessuti, ottimizzando l'integrità della linea di graffatura e riducendo i rischi di danni ai tessuti.
Il dispositivo è approvato per procedure toraciche, colorettali e urologiche negli Stati Uniti. Il sistema da Vinci SP consente ai chirurghi di controllare fino a tre strumenti articolati e una telecamera HD 3D attraverso un unico punto di accesso, promuovendo un recupero più rapido dei pazienti e riducendo il dolore post-operatorio. Il sistema triangola gli strumenti all'interno del corpo, aiutando a prevenire le collisioni degli strumenti esterni in spazi chirurgici ristretti.
Intuitive (ISRG) ha recibido la aprobación de la FDA para su grampador SP SureForm 45, diseñado específicamente para cirugía robótica de puerto único con el sistema quirúrgico da Vinci SP. El grampador cuenta con la tecnología SmartFire que monitorea continuamente la compresión del tejido, optimizando la integridad de la línea de grampado y reduciendo los riesgos de daño tisular.
El dispositivo está aprobado para procedimientos torácicos, colorrectales y urológicos en los EE. UU. El sistema da Vinci SP permite a los cirujanos controlar hasta tres instrumentos articulados y una cámara HD 3D a través de un único punto de acceso, promoviendo una recuperación más rápida del paciente y reduciendo el dolor postoperatorio. El sistema triangula los instrumentos dentro del cuerpo, ayudando a prevenir colisiones de instrumentos externos en espacios quirúrgicos pequeños.
Intuitive (ISRG)는 SP SureForm 45 스테이플러에 대해 FDA 승인을 받았습니다. 이 스테이플러는 다빈치 SP 수술 시스템을 이용한 단일 포트 로봇 수술을 위해 특별히 설계되었습니다. 이 스테이플러는 SmartFire 기술을 특징으로 하여 조직 압축을 지속적으로 모니터링하고, 스테이플 라인의 무결성을 최적화하며 조직 손상 위험을 줄입니다.
이 장치는 미국에서 흉부, 대장, 비뇨기과 수술에 대해 승인되었습니다. 다빈치 SP 시스템은 외과의사가 단일 접근 지점을 통해 최대 세 개의 관절형 도구와 HD 3D 카메라를 제어할 수 있게 하여, 환자의 회복을 빠르게 하고 수술 후 통증을 줄입니다. 이 시스템은 신체 내부에서 도구를 삼각 측량하여 작은 수술 공간에서 외부 도구 충돌을 방지하는 데 도움을 줍니다.
Intuitive (ISRG) a reçu l'approbation de la FDA pour son agrafeuse SP SureForm 45, conçue spécifiquement pour la chirurgie robotique à port unique avec le système chirurgical da Vinci SP. L'agrafeuse est équipée de la technologie SmartFire qui surveille en continu la compression des tissus, optimisant l'intégrité de la ligne d'agrafage et réduisant les risques de dommages aux tissus.
Le dispositif est approuvé pour des interventions thoraciques, colorectales et urologiques aux États-Unis. Le système da Vinci SP permet aux chirurgiens de contrôler jusqu'à trois instruments articulés et une caméra HD 3D par un point d'accès unique, favorisant une récupération plus rapide des patients et réduisant la douleur postopératoire. Le système triangule les instruments à l'intérieur du corps, aidant à prévenir les collisions d'instruments externes dans des espaces chirurgicaux restreints.
Intuitive (ISRG) hat die FDA-Zulassung für seinen SP SureForm 45 Heftgerät erhalten, das speziell für die Roboterchirurgie mit einem einzigen Zugangspunkt im da Vinci SP chirurgischen System entwickelt wurde. Das Heftgerät verfügt über die SmartFire-Technologie, die kontinuierlich die Gewebecompression überwacht, die Integrität der Heftlinie optimiert und das Risiko von Gewebeschäden verringert.
Das Gerät ist in den USA für thorakale, kolorektale und urologische Eingriffe zugelassen. Das da Vinci SP System ermöglicht es Chirurgen, bis zu drei gelenkige Instrumente und eine HD 3D-Kamera über einen einzigen Zugangspunkt zu steuern, was eine schnellere Genesung der Patienten und weniger postoperative Schmerzen fördert. Das System trianguliert die Instrumente im Körper und hilft, Kollisionen mit externen Instrumenten in kleinen chirurgischen Räumen zu vermeiden.
- FDA clearance expands Intuitive's surgical stapler portfolio into single-port procedures
- Technology reduces reliance on surgical assistants, potentially decreasing operating time
- SmartFire technology offers enhanced safety features for tissue management
- System's design minimizes external instrument collisions in small surgical spaces
- SP SureForm 45 stapler not cleared for transoral otolaryngology procedures despite system approval
- to specific surgical procedures in the U.S. market
Insights
The FDA clearance of Intuitive's SureForm 45 stapler for the da Vinci SP system represents a significant strategic advancement in the company's single-port robotic surgery portfolio. As the first stapler designed specifically for single-port procedures, this innovation strengthens Intuitive's competitive moat in minimally invasive surgery.
This approval expands Intuitive's addressable market across three major surgical specialties (thoracic, colorectal, and urology), potentially accelerating adoption of the da Vinci SP platform. The integration of SmartFire technology—which continuously monitors tissue compression—addresses a critical clinical need while potentially reducing complications and improving surgical outcomes.
From a competitive standpoint, this clearance further differentiates Intuitive from emerging robotics competitors who lack similar single-port capabilities. The timing is particularly advantageous as Intuitive continues building its installed base while competitors are still developing their initial platforms.
By enabling surgeons to maintain control without assistant-fired staplers, this technology addresses the surgical workflow inefficiencies that hospitals increasingly scrutinize when evaluating robotics investments. This approval strengthens Intuitive's razor-blade business model, potentially driving increased procedure volumes and the associated instrument/accessory revenue that represents approximately
The SP SureForm 45 stapler clearance addresses a significant gap in single-port robotic surgery capabilities. The fully wristed design enables precise staple placement in anatomically challenging locations while maintaining the benefits of the single-port approach—namely reduced access trauma and improved cosmetic outcomes.
The clinical significance extends beyond convenience. By eliminating the need for bedside assistant stapling, this technology reduces potential variability in staple line quality and minimizes coordination challenges during critical portions of procedures. The SmartFire technology's continuous monitoring of tissue compression represents an important safety advancement, as staple line integrity directly impacts complication rates.
For thoracic procedures, particularly anatomic lung resections, the ability to articulate a stapler through a single port could significantly reduce intercostal nerve trauma associated with multiple port placements. In colorectal procedures, this technology facilitates complex pelvic dissection while maintaining precise control during critical anastomoses. For urologic applications, particularly radical prostatectomy, the system enables preservation of critical neurovascular structures while maintaining the single-port approach's benefits.
Hospital administrators will note potential efficiency gains from reduced operating times and the elimination of additional personnel previously needed for stapling tasks. With increasing pressure to improve surgical throughput, technologies that streamline workflow while improving outcomes position themselves favorably for institutional adoption.
Intuitive’s SureForm 45 stapler available for thoracic, colorectal, and urology procedures
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
+1 202-997-7373
peper.long@intusurg.com
About Intuitive
Intuitive (NASDAQ:ISRG), headquartered in Sunnyvale, California, is a global leader in minimally invasive care and the pioneer of robotic surgery. Our technologies include the da Vinci surgical system and the Ion endoluminal system. By uniting advanced systems, progressive learning, and value-enhancing services, we help physicians and their teams optimize care delivery to support the best outcomes possible. At Intuitive, we envision a future of care that is less invasive and profoundly better, where disease is identified early and treated quickly, so that patients can get back to what matters most.
About da Vinci Surgical Systems
There are several models of the da Vinci surgical system. The da Vinci surgical systems are designed to help surgeons perform minimally invasive surgery and offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels, and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.
For more information, please visit the company’s website at www.intuitive.com.
Important Safety Information
For product intended use and/or indications for use, risks, cautions, and warnings and full prescribing information, visit https://manuals.intuitivesurgical.com/market. For summary of the risks associated with surgery refer to www.intuitive.com/safety.
Forward-Looking Statements
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FAQ
What procedures is the ISRG SP SureForm 45 stapler FDA-cleared for?
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In which regions is ISRG's da Vinci SP surgical system approved?
