The company added the approval included a review of the Senhance Surgical System platform, making Senhance one of the first robotic surgical systems to be approved through the new, more rigorous EU Medical Device Regulation, or MDR, process.
Asensus Surgical President and CEO, Anthony Fernando said the new process was significantly “more stringent” than in years past. He also commented on previous approvals for the technology.
“This is the second iteration of the software that we got approval for,” Fernando told MD+DI. “We’ve had approval in the U.S., which we [received] about a year-and-a-half ago and then we simultaneously got approval in Japan. Given the MDR transition, we didn’t have the same level of approval in Europe that we had for the second version of this software upgrade.”
The newest ISU features introduce more advanced features including 3D measurement, digital tagging, image enhancement, and enhanced intraoperative camera control based on real-time data.
The features will help give the company a leg up in the fierce competition its facing from other surgical robotic technologies in the space. Fernando said that Europe is a key market for Asensus.
“There are two reasons why Europe is the largest market,” he said. “One, [Senhance] was originally approved there and the company originally had roots in Europe. The second reason is … Europe compared to the U.S. has a greater number of laparoscopically trained surgeons. Second Europe is a significantly more cost-responsible healthcare system compared to the U.S. They are very sensitive to cost – Everyone from the [hospital]administration to the surgeon.”
He added, “Our offering meets that. We are a laparoscopic system so the approach is laparoscopic so our cost profile on a per-procedure basis is almost similar to laparoscopy in anywhere between 50% to 70% lower than [Intuitive Surgical’s] da Vinci. As a result, the adoption is pretty high because the surgeons and the administration want technology, but they don’t want to pay too much.”
Fernando took over the helm of Asensus in November of 2019. On Episode of 15 of Let’s Talk Medtech, he shared his vision for the company and spoke about the surgical robotics landscape.
Original Article: (https://www.mddionline.com/robotics/new-approval-reinforce-asensus-strength-europe-market)
