Medtronic has launched a 2,500-patient, international study to assess real-world impact of its superDimension(TM) navigation system. The idea is that the study will support the company’s quest to make the system the global standard-of-care for obtaining lung tissue biopsies from the periphery of the lungs.
Background
With a historical lack of effective, non-invasive diagnostic technologies, lung cancer remains the number one cancer killer in the world, accounting for more cancer deaths than breast, colon and prostate cancer combined, says Medtronic in a new press release.
The global study is being run by Medtronic’s Minimally Invasive Therapies Group and will take place in up to 75 centers. Known as NAVIGATE, the single-arm, multi-center post-market observational study will enroll patients to evaluate the diagnostic performance of Electromagnetic Navigation Bronchoscopy (ENB) procedures and follow them up for 24 months. It will also determine how often physicians use the technology to successfully obtain biopsy samples from the surrounding lymph nodes and place fiducial markers or dyes to guide subsequent procedures to ablate or remove lung tumors.
Medtronic’s superDimension system has received FDA 510(k) clearance in the United States, CE Mark in Europe and it has also been approved for use in numerous international markets.
The LungGPS(TM) technology used in the superDimension system is the first of its kind to enable ENB procedures. ENB provides a minimally invasive approach to access difficult-to-reach areas of the lung, which can aid in the diagnosis of lung disease and thereby lead to earlier, personalized treatment – potentially saving lives.
Investigator comments
“With the introduction of ENB procedures, we can now navigate through the lung allowing us to screen for cancer and other diseases without surgery,” said Erik Folch, MD, interventional pulmonologist at Beth Israel Deaconess Medical Center in Boston, and co-National Lead Investigator of the NAVIGATE study. “With this minimally invasive diagnostic approach now available, we are able to manage thousands of patients with suspicious lung nodules that show up on computerized tomography (CT) scans without resorting to surgery. This important study holds the key to determining the real-world impact of this minimally invasive approach that, I believe, could significantly reduce the mortality of lung cancer.”
“As lung cancer screening initiatives increase and we find more suspicious lung nodules, it is especially critical to provide minimally invasive diagnostic options earlier so patients can receive treatment sooner and have better chances of long-term survival,” said Sandeep Khandhar, MD, a CVTSA thoracic, surgical director of thoracic oncology at Inova in Falls Church, Virginia and co-National Lead Investigator of the NAVIGATE study. “We are at a crucial time where diagnostic and surgical technologies have advanced to a level where I believe there could be a significant shift in patient outcomes and many patients can go on to lead long, active and healthy lives after a lung cancer diagnosis, which was almost unheard of even 10 years ago.”
Company comments
“Medtronic is committed to providing innovative diagnostic and therapeutic solutions for lung disease that have the potential to transform care and improve outcomes for patients worldwide,” said Michael Tarnoff, MD, vice president and chief medical officer, Minimally Invasive Therapies Group at Medtronic. “We hope the NAVIGATE study will help confirm the impact of ENB procedures that we have seen in over 50,000 cases performed at more than 600 hospitals commercially and as part of prior clinical trials. Given the results seen to date, we are confident that this approach has the potential to become a recommended global standard of care to aid in diagnosis of peripheral lung lesions.”
Source: Medtronic, plc
published: September 22, 2015 in: Clinical Studies/Trials, Medtronic, Oncology, Thoracic/Respiratory