Ion lung biopsy system from Intuitive Surgical wins FDA approval

Intuitive Surgical Inc. yesterday said that the U.S. Food and Drug Administration approved its Ion system. The robotic endoluminal system is designed to enable doctors to conduct minimally invasive biopsies deep within the lung.

Ion includes an articulating robotic catheter with an outer diameter of only 3.5 mm that is able to move 180 degrees in all directions, allowing a physician to navigate the catheter through small and tortuous airways to reach nodules.

Intuitive Surgical’s Flexision Biopsy Needle is also able to pass through tight bends as it travels through the Ion’s catheter to collect peripheral lung tissue. Other biopsy tools are also able to fit inside the catheter’s 2 mm working channel, including biopsy forceps or cytology brushes.

Ion‘s fiber-optic, shape-sensor technology provides the catheter’s precise location and shape information throughout the procedure. Intuitive said it designed the Ion system to easily integrate into existing lung nodule biopsy workflows. Ion can also integrate with existing imaging technology, such as 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 Intuitive Surgical CEO Gary Guthart. “At Intuitive, we innovate for need, and lung cancer is clearly a global health challenge that requires new modalities of care.”

Ion to meet minimally invasive surgery needs

“Lung cancer is the world’s leading cause of cancer deaths,” stated Sunnyvale, Calif.-based Intuitive Surgical. “Many suspicious lesions found in the lung may be small and difficult to access, which can make obtaining a diagnosis challenging.”

One noteworthy recent lung cancer surgery patient is Supreme Court Justice Ruth Bader Ginsburg. Minimally invasive lung surgery can lead to shorter recovery times. The lung cancer surgery market will grow from $21.58 billion in 2016 to $29.99 billion in 2021, predicts Markets and Markets.

The global market for surgical robotics is experiencing a compound annual growth rate of 8.4 percent and will reach $98 billion by 2024, according to Knowledge Based Value Research.

Intuitive Surgical and its da Vinci system have been the market leaders for years. Physicians at Northwestern Memorial Hospital in Illinois recently used a da Vinci Xi for the first robot-assisted lung volume reduction surgery to treat severe emphysema resulting from chronic obstructive pulmonary disease.

However, Intuitive is facing increasing competition from companies such as Medtronic, Transenterix, and Verb Surgical. Johnson & Johnson last week acquired Auris Health, whose Monarch platform is intended for diagnostic and therapeutic bronchoscopic procedures. Corindus Vascular Robotics applied for FDA approval of its CorPath GRX system for neurological surgery.

“In the technology space, you have a lot people realizing the technologies necessary to build robots are more approachable than they have been in the last 10 years,” said Roger Smith, M.D., chief technology officer of the Florida Hospital Nicholson Center. “This means that a lot of the necessary pieces are now in place, and you can put a company together and put a device together that does something unique, and it won’t cost you $500 million to do it. That’s how you end up with 57 companies.”

Intuitive Surgical is working to stay ahead of the competition by innovating and expanding into overseas markets. It plans a gradual rollout of Ion, with sales and shipping starting in the U.S. in the second quarter of 2019.