Asensus Surgical, a medical device company seeking to digitize the interface between the surgeon and the patient, received 510(k) clearance from the FDA for an expanded indication to treat pediatric patients with the Senhance surgery system.
The Senhance System is already approved for surgery on pediatric patients in the EU and Japan.
“We are excited to bring the benefits of surgical robotic technology to the underserved pediatric patient population in the United States. Given the small size of the patients, pediatric surgery seeks to use the least invasive instruments and scopes, while maintaining a high level of precision and stability. The Senhance System is uniquely qualified to meet these needs of pediatric surgeons,” says Anthony Fernando, Asensus Surgical President and CEO. “We look forward to bringing all of our learnings from over three years of performing pediatric procedures in Europe and Japan to the US.”
With the combination of 3mm instrumentation, 5mm camera scope, haptic feedback, and advanced clinical intelligence provided by the Intelligent Surgical Unit, the company believes that the Senhance System is positioned to bring unique benefits of surgical robotics to pediatric patients by offering an improved reduction in invasiveness on a robotic platform.
“The Senhance System is the perfect robotic platform for use in pediatric patients,” says Thom Lobe, MD, pediatric surgeon at the Sinai Health System in Chicago. “No other robotic system uses reusable 3mm instruments suitable for smaller patients. For those familiar with laparoscopic surgery, the system is easy to learn and has several advantages including economical value, a camera system controlled by the surgeon’s eyes, and improved safety features such as haptic feedback.”
