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Intuitivo consigue la AUTORIZACIÓN del FDA para el accesorio de la robusteza

por Brendon Nafziger, DOTmed News Associate Editor | December 13, 2011
Da Vinci Si system (Credit: Intuitive)
Intuitive Surgical Inc. said Monday it received Food and Drug Administration clearance for an accessory that lets the da Vinci surgical robot perform gallbladder surgery with a single incision. Analysts say this could one day help make the robot more attractive in the general surgery space.

The Single-Site Instrumentation kit includes a set of three instrument types, which are compatible with the robot, and are indicated for cholecystectomy, or the removal of the gallbladder. The kit works with the company's da Vinci Si systems.

The kit is one of three products Intuitive has in the works to broaden the appeal of its platform to general surgery, according to Rick Wise, with health care investment bank Leerink Swann. The other two, which haven't been cleared, are a surgical stapler and vessel sealer.
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Roll-out of the device began in Europe several quarters ago, according to Wise, but was limited to under two dozen centers. Intuitive expects a "controlled" launch in the United States.

Wise said this was, for now, an early-stage technology.

"Single-incision surgery in general is in its early stages of adoption and its usage to date has been relatively limited," he said in a note to investors Tuesday.

In the release, Intuitive's CEO Gary Guthart said they would likely file future submissions with the FDA to expand the indications for the product.

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