Transenterix Inc., of Research Triangle Park, N.C., said Tuesday that it has filed a 510(k) submission with the U.S. FDA for the Intelligent Surgical Unit (ISU), a machine vision system designed to work with its robotic Senhance surgical system. The new technology would equip users of the Senhance system with augmented intelligence to improve performance and surgical outcomes.
If all goes as planned, the company expects to launch the ISU in the U.S. in mid to late 2020.
“Transenterix is the first company to seek FDA clearance for machine vision in abdominal robotic surgery,” said Anthony Fernando, Transenterix’s president and CEO. “Rather than simply passing a video signal to the surgeon, the Intelligent Surgical Unit for Senhance will initially have the ability to actually visualize the surgical field to guide movement and capture information.”
Cleared by the FDA in October 2017 for use in laparoscopic abdominal procedures, the Senhance system already provides surgeons with eye-tracking camera control, providing a 3D high-definition view of the surgical field while they remotely manipulate three separate robotic arms equipped with surgical instruments. The ISU would give surgeons machine vision-driven control of the camera by responding to commands and specific objects and sites in the surgical field.
“The opportunity is to see the surgical field to either help drive actions or avoid important structures – also to prevent motion outside the field of view, which can be a risk in surgery,” Fernando told BioWorld MedTech. “Ultimately, augmented intelligence may allow for an overwatch capability to help recognize structures and identify complex anatomy and pathologies.”
To support its 510(k) filing for the ISU, Transenterix submitted full usability studies with surgeons, as well as validation studies in labs to confirm its use in surgical procedures, he said.
The unit is designed to work with the global installed base of Senhance systems, as well as third-party vision systems that are supported by Senhance, by connecting directly with the surgical console. In addition, its hardware was designed to accommodate future augmented intelligence features such as scene cognition and surgical image analytics aimed at further enhancing digital laparoscopy with Senhance.
“The goal is the additional capabilities of detailed measurement, setting landmarks to automate return to certain anatomical locations and moving toward structural identification, all enabled with machine vision,” Fernando said.
30% uptick in procedures
Machine vision could provide a strong marketing angle for sales of the Senhance system, which has seen a steady increase in use in laparoscopic surgeries. The system is indicated for use in gynecological and colorectal procedures, as well as cholecystectomy and inguinal hernia repair. During a third-quarter earnings call in November, Fernando cited a 30% upswing in procedures in the first 10 months of 2019, compared with 2017 and 2018 combined. In addition to its FDA clearance, Senhance has been CE marked since 2018 and gained regulatory and reimbursement approvals in Japan in 2019.
Transenterix recently signed agreements with two new hospitals in the U.S. and Germany that plan to deploy Senhance in digital laparoscopy programs in the first quarter of 2020.
Fernando said the company “will continue to pursue greater adoption and increased clinical sites.” Among other things, the company wants to convert more existing sites in the U.S., Europe and Japan into “foundational” sites that perform a hundred or more cases a year in a variety of specialties.
Senhance got off to a somewhat shaky start, due to Transenterix’s decision to skip the usual limited precommercial release and launch Senhance without a full complement of instruments and user feedback. Since then, the company has focused on ensuring the availability of advance energy and other instruments to support the system, as well as compatibility with third-party vision systems.
For 2019, Transenterix anticipates revenue in the $8.3 million to $8.5 million range. The revenue stems from the sale of three Senhance systems and related consumables and service contracts. During the year, the company won an FDA nod for its Senhance Ultrasonic Instruments, began a limited European release of 5 mm articulating instruments, launched the Senhance System Simulator and filed a CE submission for expanded Senhance indications for pediatric patients.