A large, yearlong Medtronic study found its electromagnetic navigation system allowed bronchoscopes to better reach difficult areas of the lung and diagnose cancer earlier.
Specifically, the study found that 65% of the patients diagnosed with primary lung cancer were found to be in the earliest stages—with about half of lesions measuring less than 20 mm in diameter—at times when early detection can be critical to improving long-term outcomes.
"These data demonstrate that, for the first time, both academic and community-based care clinicians can safely obtain a diagnosis in small, peripheral lung lesions, and then stage and prepare for future treatment in a single minimally invasive procedure," said study co-lead investigator Erik Folch, chief of the Complex Chest Disease Center at Massachusetts General Hospital.
While replicating real-world conditions, the study evaluated the diagnostic yield and complication rates of the med-tech giant’s Emprint ablation catheter and its superDimension navigation system for lung procedures and included long-term follow up of negative cases. The study’s results, published in the Journal of Thoracic Oncology, included 12 months of follow-up of 1,215 patients at 29 medical centers in the U.S.
The procedure was successfully completed in 94% of study patients and a navigation-assisted diagnosis was obtained in 73%. In addition, the procedure had lower complication rates.
Specifically, organ wall injuries causing a collapse of the lung, or pneumothorax, occurred in only 4.3% of patients, compared to previously published rates ranging between a fifth and a quarter of transthoracic needle biopsies, Medtronic said.
The superDimension system has received 510(k) clearance from the FDA as well as a CE Mark in Europe and has also been approved in Japan, Korea and China. The Emprint ablation catheter kit has a CE Mark but is not cleared in the U.S.
Medtronic is planning a prospective study in up to 30 patients to evaluate the safety and performance of bronchoscopic thermal ablation using the Emprint catheter when guided by the superDimension system.