Lung cancer is still one of the top killers due in part to the challenges of early diagnosis. So my interest was piqued when I heard of a large study that Medtronic was conducting to test its new superDimension navigation system that enables a new technique for capturing tissue samples for biopsy and investigating lung lesions. It also improves the ability to explore deeper into the lung, allowing doctors to see into the “dark corners” that prove to be a challenge for other solutions. In this interview, Chris Barys, vice president and general manager of Interventional Lung Solutions at Medtronic, spoke with MDT about the technology, the capabilities it offers, and the reason behind the large study.
Sean Fenske: Thank you for sharing your insights with MDT. Let’s get right into it. Tell me about the superDimension navigation system and how it works?
Chris Barys: The superDimension navigation system provides a minimally invasive approach to aid in the diagnosis of lung lesions and can be used to acquire ample tissue to enhance molecular genetic analysis/profiling of tumors for targeted therapy. The system enables access to difficult-to-reach areas of the lung by using a patient’s CT scan, electromagnetic navigation, a bronchoscope, and proprietary LungGPS software. The technology uses advanced imaging and computer modeling to create a three-dimensional rendering and a detailed roadmap of a patient’s airways, allowing a doctor to take a biopsy from areas of the lung that couldn’t be found by viewing CT scans alone.
Physicians receive a detailed chest scan that yields more than 300 separate cross-section images of the lungs. A computer analyzes those images and creates a three-dimensional model of each lung’s unique airways. The doctor can use the roadmap to guide a skinny probe through the nose or mouth to existing airways within millimeters of a lesion, without cutting skin, to obtain tissue for a lung biopsy.
Fenske: What motivated Medtronic to explore technology solutions for the lung cancer space?
Barys: Lung cancer remains the number one cancer killer in the United States, accounting for more cancer deaths than breast, colon, and prostate cancer combined.
In its early stages, lung cancer presents few, if any, symptoms. As a result, we see a vast majority of lung cancer patients diagnosed in the late stages, when there is minimal chance for long-term survival. While concerning, there is technology that is changing the way we screen for lung cancer to allow for earlier diagnosis.
Our goal, across the continuum of care, is to diagnose earlier, intervene earlier, treat better, and help patients recover faster.
Screening may provide new hope for early detection and treatment of lung cancer. As more patients get screened for lung cancer, more suspicious lung nodules can be found earlier through the minimally invasive diagnostic methods available to doctors, helping them diagnose lung cancer and treat patients sooner.
Fenske: How is superDimension differentiated from the current standard?
Barys: The superDimension system offers the potential for a significant, clinically meaningful advantage over existing technologies for aiding in the diagnosis and management of lung lesions. Unlike traditional tools to aid with diagnosis, this technology is minimally invasive and is the first of its kind to reach deep into the outer areas of the lung where early nodules are found.
The current standard of care (i.e., transthoracic needle aspiration) carries a pneumothorax rate as high as 42%, chest tube insertion rates of up to 17%, and risk of hemoptysis and hemorrhage rates of up to 10%. Invasive procedures may also carry a higher risk of morbidity and mortality.
In addition, Electromagnetic Navigation Bronchoscopy (ENB) procedures using the superDimension system may help control the cost of care by avoiding multiple procedures. ENB procedures using the superDimension system can not only aid in diagnosis, they can help prepare patients for treatment with fiducial marker placement for subsequent treatment by radiation and dye marker placement for subsequent treatment by surgery. ENB procedures using the superDimension navigation system have also aided in the successful diagnosis of lymph nodes and can be used to acquire ample tissue to enhance molecular genetic analysis/profiling of tumors for targeted therapy.
Fenske: What is the thinking behind performing such a large lung study?
Barys: Medtronic’s Minimally Invasive Therapies Group recently launched an international study expected to include 2,500 patients. The NAVIGATE study will assess the impact of our superDimension navigation system.
The NAVIGATE study may determine the impact of this minimally invasive approach, which we believe has the potential to become a recommended global standard of care to aid in the diagnosis of peripheral lung lesions. When diagnosed early, an estimated 85% of lung cancer cases appear at a more curable stage.
We are hopeful that ENB procedures have the potential to become a global standard of care to help with early diagnosis of peripheral lung lesions. The NAVIGATE study will provide greater insight into the impact of this minimally invasive approach, which we believe could significantly reduce the mortality of lung cancer.
To date, we have already seen 50,000 ENB cases performed at more than 600 hospitals.
Fenske: What were the primary challenges associated with the development of the technology?
Barys: We had to accommodate the complex nature of the lung anatomically and physiologically. The lung is sponge-like in that it’s highly deformable, and is constantly moving due to motion associated with respiration. Therefore, it was especially difficult to develop algorithms to reconstruct and segment the lung into a 3D map and be able to “register” that map back to the patient.
Prior to the superDimension navigation system, it was difficult for technologies to reach the distal 2/3 of the lung using an endoscopic approach. We faced the challenge of developing the electro-magnetic navigation hardware, sensors, and interventional navigation devices and tools that could not only work with, but overcome the limitations of conventional bronchoscopy. It was crucial that the work-flows and functionality of the superDimension system platform would allow physicians to repeatedly and reliably reach, access, and sample areas within the lung.
Fenske: What innovative technology advancements are really driving this technology?
Barys: The LungGPS technology inside the superDimension system creates a three-dimensional rendering of a patient’s airways, providing a minimally invasive approach to access difficult-to-reach areas of the lung. This allows the doctor a detailed roadmap of a patient’s airways and can aid in the diagnosis of lung disease and may help patients with lung cancer get earlier diagnoses and those with benign lesions avoid surgery.
Fenske: Will the core technology transfer into other devices, enabling tissue biopsies in other locations of the body?
Barys: Our goal is to unlock this capability and core technology for other diagnostic and therapeutic applications in other lung disease states that Medtronic focuses on. We want to develop and provide complete solutions, rather than just devices or products. Additionally, we want to expand our lung applications beyond lung cancer, and leverage our capabilities and technology to serve huge unmet needs across lung health, including COPD, asthma, and infection disease.
Fenske: What’s on the horizon for this technology? What will the next version bring?
Barys: We’re continuing to develop new real-time imaging, lung-specific devices that will provide new diagnostic and therapeutic procedure applications, as well as reduce the number of procedures physicians will need to perform on patients.
Fenske: Any other comments you’d like to share?
Barys: One of the main difficulties of lung cancer treatment is detecting it in its early stages. Most lung cancers have already spread widely and are at an advanced stage when they are first found and at that point, they are difficult to cure.
Early detection of lung cancer is critical. Over half of people with lung cancer die within one year of being diagnosed. An emphasis must be placed on detecting and diagnosing lung cancer at the early stages, when it can more easily be treated.