Intuitive has snagged a clearance from the FDA for a surgical stapler system designed for its single-port robotic platform, in what it describes as an agency first.
The company’s SP SureForm 45 was greenlighted for use with its da Vinci SP system, spanning minimally invasive thoracic, colorectal and urologic procedures.
Compared to its other robotic surgery systems—for example, the latest da Vinci 5, with its multiple arms that may operate through more than one opening in the body—the da Vinci SP can deliver three instruments, such as forceps and cutters, plus a 3D camera all through a single incision.
The SP SureForm 45 is built off the same technology as its multiport counterpart, including systems to monitor tissue compression before and during stapling to ensure a secure hold and reduce the risk of damage.
“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,” Intuitive Chief Medical Officer Myriam Curet, M.D., said in a statement. “This kind of control can help save valuable operating time.”
While the da Vinci SP system is also cleared in the U.S. for transoral procedures for the mouth and throat, the SureForm 45 stapler instrument was not.
Late last month, Intuitive also put forward two preclinical studies of the force feedback capabilities included with its da Vinci 5 robot, with its full-scale commercial launch set for this year.
According to the company, the experiments found that force feedback at the surgeon’s control console led to gentler surgeries—with reductions in the total force applied to tissue models, during practice procedures of retraction, dissection and suturing.
“The lack of a way to measure the forces applied to tissue may result in excessive force exerted, leading to unintentional tissue damage during surgery, which could have a negative clinical impact on patients including pain and recovery time,” said Michael Awad, M.D., Ph.D., a professor of surgery at Washington University School of Medicine in St. Louis, who helped conduct one of the studies published in the journal Surgical Endoscopy.
That paper saw reductions in force by as much as 43% regardless of the surgeon’s experience level. The second study, performed at Cedars-Sinai Medical Center in Los Angeles, showed that novice surgeons saw less tissue trauma and fewer errors during suturing.
“Suturing can be a unique challenge during robotic surgery because excessive force can break delicate sutures or injure healthy tissue, while insufficient forces might cause slippage or loose sutures,” said Andrew Hung, M.D., an associate professor of urology and computational biomedicine at Cedars-Sinai.