Dive Brief:
- Johnson & Johnson said Tuesday it received an investigational device exemption (IDE) from the Food and Drug Administration to start a U.S. clinical trial for its Ottava surgical robot.
- The company said it will now prepare U.S. sites to receive Ottava systems, enroll patients and begin surgical cases as it focuses on training clinical trial investigators. J&J’s soft tissue robot will compete with Intuitive Surgical’s da Vinci system, which currently leads the market.
- The Ottava platform will incorporate J&J Ethicon surgical instruments designed for the robotic platform, the company said. Ottava will also have a digital system called Polyphonic that will connect surgical technologies, robotics and software, ultimately adding data and insights to support clinical decision making.
Dive Insight:
J&J aims to become the next big challenger to Intuitive, which has dominated robot-assisted soft tissue surgery for more than two decades. Intuitive is in the midst of rolling out the latest version of its flagship da Vinci system with a series of enhancements the company says physicians have praised.
Medtronic, which sells its Hugo robotic system in international markets including Europe, Japan and Canada, and a host of smaller competitors are also looking to take on Intuitive.
J&J said in the announcement that Ottava is designed to address “unmet needs that persist in robotic surgery,” while driving choice and competition in an underpenetrated and high-growth market.
“We are bringing the best of J&J MedTech’s surgery expertise to the [Ottava] system and taking a holistic view of the science of surgery to enable new experiences across all surgical modalities,” Hani Abouhalka, J&J’s group chairman of surgery, said in a statement.
The Ottava robot has four arms incorporated into the operating table that can be stored underneath. The architecture allows for a compact footprint that can support robotic, laparoscopic, hybrid and open surgery, according to the company. The table and robotic arms move together for intraoperative repositioning.
J&J said the system’s exclusive Ethicon instrumentation supports consistency between robotic and traditional laparoscopic procedures.
