Virtual Incision Corporation today announced the successful first-in-human use of its miniaturized robotically assisted surgical device (RASD) for colon resection, a procedure performed to treat patients with lower gastrointestinal diseases. These diseases include diverticulitis, colon polyps that are too large to be removed endoscopically, pre-cancerous and cancerous lesions of the colon, and inflammatory bowel disease.
“To the best of our knowledge, this is the first time an active miniaturized robot has performed complex surgical tasks with the robot inside a living human, which is a significant milestone in robotics and in surgery,” said Shane Farritor, Virtual Incision’s co-founder and chief technical officer.
The robotically assisted colon resection procedures were completed in Asunción, Paraguay, as part of the safety and feasibility trial for the technology. The surgeries were successful and the patients are recovering well.
“Virtual Incision’s robotically assisted surgical device achieved proof-of-concept in highly complex abdominal procedures,” said head surgeon Dmitry Oleynikov, MD FACS, chief of minimally invasive surgery at the University of Nebraska Medical Center and co-founder of Virtual Incision. “Additionally, we verified that our extensive regimen of bench, animal, cadaver, biocompatibility, sterilization, electrical safety, software, human factors and other testing enabled the safe use of this innovative technology.”
Unlike today’s large, mainframe-like robots that reach into the body from outside the patient, Virtual Incision’s robot platform features a small, self-contained surgical device that is inserted through a single midline umbilical incision in the patient’s abdomen. Virtual Incision’s technology is designed to utilize existing tools and techniques familiar to surgeons, and does not require a dedicated operating room or specialized infrastructure. Because of its much smaller size, the robot is expected to be significantly less expensive than existing robotic alternatives for laparoscopic surgery. Virtual Incision’s technology promises to enable a minimally invasive approach to surgeries performed today with a large open incision.
“The benefits of robotically assisted surgical procedures have been proven time and time again. However, existing surgical robots have limitations that prevent their pervasive use during certain surgeries, such as colon resection, which Virtual Incision’s technology is specifically designed to overcome,” said John Murphy, CEO, Virtual Incision. “The positive completion of this feasibility study is a key milestone and a great foundation to build upon as we work toward FDA 510(k) clearance for the system in the United States.”
More than two million patients undergo colon resection procedures globally each year. Approximately two-thirds of these procedures are performed via a completely open surgical procedure involving an 8- to 12- inch incision and up to six weeks of recovery time. Because of the complicated nature of the procedure, existing robotically assisted surgical devices are rarely used for colon resection surgeries, and manual laparoscopic approaches are only used in one-third of cases due to their difficulty and complexity.