US FDA Grants Clearance for Ion by Intuitive

Intuitive Surgical (NASDAQ:ISRG) has announced that the US Food and Drug Administration has cleared the Ion endoluminal system for less invasive biopsies in the peripheral lung.

As quoted in the press release:

Lung cancer is the world’s leading cause of cancer deaths. Many suspicious lesions found in the lung may be small and difficult to access, which can make obtaining a diagnosis challenging.

“Early lung cancer diagnosis can save lives. 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,” said Gary Guthart, Intuitive CEO.

The Ion system uses an ultra-thin articulating robotic catheter that can move 180 degrees in all directions. The outer diameter of the catheter is 3.5 mm, which physicians can navigate through small and tortuous airways to reach nodules in any airway segment within the lung. The Ion system’s flexible biopsy needle (called the Flexision Biopsy Needle) can also pass through very tight bends via Ion’s catheter to collect tissue in the peripheral lung. The catheter’s 2mm working channel can also accommodate other biopsy tools, such as biopsy forceps or cytology brushes, if necessary.

Intuitive developed the system’s fiber optic shape sensor technology to provide the physician with the precise location and shape information of the catheter throughout the navigation and biopsy process.

Intuitive designed the Ion system to easily integrate into existing lung nodule biopsy workflows, as well as existing imaging technology, including fluoroscopy, radial-endobronchial ultrasound, and cone-beam CT.

“The Ion system represents Intuitive’s continued commitment to innovating for minimally invasive care, and extends our focus beyond surgery,” said Guthart. “At Intuitive, we innovate for need, and lung cancer is clearly a global health challenge that requires new modalities of care.”

Click here to read the full press release.