The Mayo Clinic Hospital at the Saint Marys Campus in Rochester, Minnesota, is already using the Asensus Senhance system for pediatric operations, the device developer said in a recent regulatory filing.
Research Triangle Park, North Carolina-based Asensus said in July that the deal made Senhance the first system exclusively utilized by pediatric surgeons at any U.S.-based hospital. The device developer named Mayo Clinic in a three-sentence filing with the Securities and Exchange Commission last month.
Rochester-based Mayo Clinic also uses Intuitive Surgical’s da Vinci system at various locations across its hospital network.
Asensus (formerly called TransEnterix) first won FDA 510(k) clearance for the system in 2017, and since then has secured expanded indications, deals with Google and Nvidia, and hospital placements in Japan, Germany, Switzerland and Russia.
Asensus Senhance features for pediatric robotic surgery
Asensus’ Senhance became the first and only digital laparoscopic surgery system for children when the FDA cleared its pediatric indication in March.
The system’s 3 mm instruments are the world’s smallest among surgical robotics platforms — and those instruments are reusable.
Asensus also designed Senhance with a 5 mm camera scope, haptic feedback, eye-tracking camera control and 3D visualization. The system uses machine learning and augmented reality to assist surgeons during procedures.
Asensus has a next-generation system called Luna that it hopes to have cleared by the FDA in 2025 for a commercial launch that same year.
Like the Senhance system, the Luna system will be a multi-port system with 3 and 5 mm instruments, haptic feedback and real-time digital tools. Asensus says the two systems will also share the same specialties for procedures: general surgery, gynecology, urology, pediatric and thoracic operations.
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