Intuitive Surgical received FDA go ahead to begin marketing its da Vinci Sp single port robot assisted surgical system. The system is initially indicated for urologic minimally invasive procedures that are already performed via a single incision.
The device delivers a 3D high-def camera and three fully articulating instruments through its 25 mm cannula. The EndoWrist Sp Instruments used by the system have two more degrees of freedom than the da Vinci Single-Site instruments previously available, allowing substantially more control for the surgeon. While the FDA has already given clearance to the system, Intuitive Surgical plans to hold off on releasing it to market until it’s been made fully compatible with the latest da Vinci Xi robot.
Here’s an exclusive video we obtained of the da Vinci Sp showing off its moves:
From the announcement
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Sp Surgical System, Model SP999) is intended to assist in the accurate control of Intuitive Surgical EndoWrist Sp Instruments during urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Intuitive Surgical EndoWrist Sp Instruments are controlled by the da Vinci Sp Surgical System, Model SP999, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single incision laparoscopic approach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The safety and effectiveness of this device for use in the performance of general laparoscopic surgery procedures have not been established. This device is only intended to be used for single port urological procedures with the da Vinci EndoWrist Sp Instruments and the da Vinci Sp Surgical System (SP999).
Press release: Intuitive Surgical Announces FDA Clearance of da Vinci(R) Sp(TM) Surgical System…