Intuitive Surgical Receives FDA Clearance for Ion™ Endoluminal System Enabling Minimally Invasive Biopsy of Deep Lung Lesions

On February 20, 2019, VCBeat (WeChat official account: vcbeat) learned that the Ion™ Endoluminal System from Intuitive Surgical (hereinafter referred to as “Intuitive”), a U.S. company specializing in robot-assisted minimally invasive surgery, had received FDA clearance. The product enables minimally invasive biopsy of deep lung regions and is expected to be launched for sale in the United States in the second quarter of 2019.

Intuitive Surgical (NASDAQ: ISRG), founded in 1995 and headquartered in Sunnyvale, California, is a company specializing in robot-assisted minimally invasive surgery. On March 7, 2003, Intuitive acquired Computer Motion; on June 1, 2009, it acquired NeoGuide Systems; and on January 22, 2014, it acquired Luna Innovations’ medical applications division for $12 million.

Intuitive has over two decades of experience in robot-assisted surgery and product development, with flagship products including the da Vinci® Surgical System and the Ion™ Endoluminal System. The da Vinci® Surgical System was among the first robot-assisted systems approved by the FDA for general laparoscopic procedures, and it comprises three components: the surgeon console, the patient-side cart (bedside robotic arm system), and the vision system.

The Ion™ Endoluminal System is Intuitive’s new robotic platform designed for minimally invasive biopsies in the peripheral lungs. The system features an ultra-thin, articulated robotic catheter capable of 180-degree movement in all directions. With an outer diameter of 3.5 mm, the catheter allows physicians to navigate small, tortuous airways to reach nodules in any segment of the pulmonary airways. The Flexision Biopsy Needle, used with the Ion™ Endoluminal System, can also be advanced through the Ion catheter via small, curved airways to collect peripheral lung tissue. Additionally, the catheter’s 2 mm working channel can accommodate other biopsy tools, such as biopsy forceps or cytology brushes.

Lung cancer is one of the cancers with high mortality rates worldwide. Early-stage lung cancer is difficult to diagnose and treat effectively because many suspicious symptoms detected in the lungs are subtle and hard to detect. Intuitive has developed fiber-optic shape-sensing technology to navigate the entire biopsy procedure, helping physicians determine the precise position and shape of the catheter, thereby enabling accurate detection of pulmonary diseases. The Ion™ Endoluminal System can be seamlessly integrated into existing workflows for lung nodule biopsy and existing imaging modalities, including fluoroscopy, radial endobronchial ultrasound (rEBUS), and cone-beam CT.

Gary Guthart, CEO of Intuitive, stated: “Early diagnosis of lung cancer can save more lives. Lung cancer is a global health challenge that demands new approaches to care. The Ion™ Endoluminal System enables physicians to obtain tissue samples from deep within the lungs, overcoming the difficulties associated with lung biopsies. This technology represents Intuitive’s innovative commitment to minimally invasive care, extending our research focus beyond surgery.”

Computer Motion is a high-tech medical device company whose main products include the AESOP 3000, a voice-controlled endoscopic positioning robot; HERMES™, a control center for voice-activated intelligent control of medical devices; and the ZEUS™ robotic surgical system for minimally invasive procedures.

NeoGuide Systems, Inc. was founded in 2000 in San Jose, California, to develop robotic endoscopy technology. Its technology can be used for colonoscopy.

Luna Innovations – Medical Applications is a shape-sensing technology, with core technologies including optical fibers, ultrasound and wireless sensing, integrated systems, and materials.

(Compiled by Zhang Yaping)