Asensus’ Senhance Surgical Robot OK’ed for U.S. Pediatric Patients

Asensus Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication to treat pediatric patients using its Senhance system. Senhance is already approved for pediatric patients in the EU and Japan.
 
Senhance’s 3 mm instrumentation, 5 mm camera scope, haptic feedback, and Intelligent Surgical Unit, according to the company, makes it capable of bringing benefits of surgical robotics to pediatric patients in a way no other platform on the market can through reduction in invasiveness on a robotic platform.
 
The company has seen strong early clinical use in Europe, with surgeons performing successful pediatric general, upper GI, colorectal, and urologic procedures using Senhance.
 
“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,” Anthony Fernando, Asensus Surgical president and CEO told the press. “We look forward to bringing all of our learnings from over three years of performing pediatric procedures in Europe and Japan to the U.S.”
 
Dr. Thom Lobe, Pediatric Surgeon at the Sinai Health System in Chicago said, “The Senhance System is the perfect robotic platform for use in pediatric patients. 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.”