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February 20, 2019

Intuitive Surgical gets FDA clearance for robot-assisted Ion system

Intuitive Surgical has received clearance from the US Food and Drug Administration (FDA) for the use of its Ion endoluminal system for minimally invasive biopsy in the peripheral lung.

Intuitive Surgical has received clearance from the US Food and Drug Administration (FDA) for the use of its Ion endoluminal system for minimally invasive biopsy in the peripheral lung.

The system comprises a robotic catheter with a 3.5mm outer diameter. It can move 180 degrees in all directions and can be used to navigate through small and complex airways to reach nodules in any airway segment of the lung.

It also consists of the Flexision Biopsy Needle that can pass through tight bends through the catheter for collecting tissue in the peripheral lung.

“The company is planning for a gradual launch of the system in the US, and shipments of the product are expected to commence in the second quarter of this year.”

The catheter features a 2mm working channel that can house other biopsy tools, including biopsy forceps or cytology brushes.

Ion comes with fibre optic shape sensor technology that is said to provide precise location and the catheter’s shape information to the physician during the navigation and biopsy process.

The system can be easily used with current lung nodule biopsy workflows and existing imaging technology such as fluoroscopy, radial-endobronchial ultrasound and cone-beam CT.

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Intuitive Surgical CEO Gary Guthart said: “Intuitive’s advanced, robotic-assisted, minimally invasive Ion system helps address a challenging aspect of lung biopsy by enabling physicians to obtain tissue samples from deep within the lung.

“The Ion system represents Intuitive’s continued commitment to innovating for minimally invasive care, and extends our focus beyond surgery.”

The company is planning for a gradual launch of the system in the US, and shipments of the product are expected to commence in the second quarter of this year.

Intuitive Surgical portfolio also includes da Vinci Surgical Systems designed to enable minimally invasive surgery (MIS) across various procedures.

Its next-generation surgical robot da Vinci Xi System was cleared by the FDA for use in complex diseases and conditions in gynaecology, urology, thoracic, cardiac and general surgery.

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