强生OTTAVA手术机器人获FDA De Novo授权，但仅选择性商业化启动

The FDA has authorized Johnson & Johnson’s Ottava Robotic Surgical System as it looks to compete with Intuitive Surgical and Medtronic.
Ottava is now FDA-approved for multiple soft tissue surgeries, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair.
“This is the start of the next era in surgery as we deliver not just a new surgical robotics system, but a catalyst for fundamentally better surgical care,” said Tim Schmid, EVP and worldwide chairman, MedTech, at Johnson & Johnson, in a release.
The company is refraining from a full rollout as yet. J&J said it will “commercially launch the Ottava system with select customers in the U.S., focusing on early customer success while working in parallel to advance into additional indications and regulatory jurisdictions over time.”
One such additional indication includes inguinal hernia, for which the Ottava system is currently in a U.S. trial.
The design of the robot allows it to fit in nearly any operating room, with four robotic arms integrated into a standard-size surgical table, removing the need for a separate boom or carts and in turn saving space.
The Ottava system will now take on Intuitive Surgical’s mainstay da Vinci robot, as well as more recent challengers from Medtronic and CMR Surgical.
But in a note to clients, J.P.Morgan analyst Robbie Marcus said the firm still sees da Vinci as the system of choice.
“While Ottava has some interesting selling points (smaller footprint), our doc checks continue to point to Intuitive as the clear favorite given its physician relationships and entrenched integration into the hospital workflow and academic programs,” he said.