Auris Health, Inc., a subsidiary of Ethicon, Inc., part of the Johnson & Johnson Medical Devices Companies*, today announced results from the world’s first prospective, multicenter study of robotic bronchoscopy. The study, called BENEFIT, evaluated the safety and feasibility of the MONARCH® Platform, a first-of-its-kind robotic technology indicated for use in diagnostic and therapeutic bronchoscopic procedures. Results of the study were published in CHEST, the official publication of the American College of Chest Physicians.
The study, led by Alexander C. Chen**, M.D., of St. Louis, Mo. and Gerard A. Silvestri**, M.D., M.S. of Charleston, S.C., assessed the safety and feasibility of utilizing the MONARCH robotic system to aid in the diagnosis of peripheral pulmonary lesions. Fifty-five patients were enrolled at five leading institutions across the United States: Washington University in St. Louis, Medical University of South Carolina, the Cleveland Clinic, Henry Ford Hospital, and Inova Fairfax Hospital.
The MONARCH Platform localized targeted nodules using a combination of direct visualization, navigational guidance and radial endobronchial ultrasound (R-EBUS). Results of the study demonstrated safety, with pneumothorax occurring in 2/54 (3.7%) of procedures, and placement of a chest tube required in 1/54 (1.9%) procedure. No additional serious adverse events were reported. In 96.2% of cases, the pre-planned target area was reached and localized as confirmed by ultrasound imaging. An exploratory analysis of overall diagnostic yield in the study was 74.1%. In addition, a diagnostic yield of 70% was achieved in lung nodules located outside of a patient’s airway. Authors noted these results compare favorably to reported yields of 30-40% using non-robotic technology for lesions outside the patient’s airway.
“This study was conducted using strict definitions for diagnostic yield. In previous studies, variations in the definition of yield led to overestimation of a successful bronchoscopy. Given this strict trial design, the diagnostic yield of 74.1% is promising, and we hope this sets the stage for future multicenter trials,” said Dr. Silvestri, Hillenbrand Professor of Thoracic Oncology at Medical University.
“We are thrilled to be making a meaningful impact on the diagnosis of lung conditions, particularly in patients with small and difficult to reach nodules that may progress to something more serious,” said Eric Davidson, President, Flexible Robotics, Auris Health, Inc. “Physicians in the study, using our first-generation MONARCH software, were able to localize and diagnose the most difficult-to-reach nodules at a higher rate than was previously possible. Since then, we have continued to improve the platform, delivering a higher level of accuracy and ease of use. We continue to build robust clinical evidence in support of the MONARCH Platform and work with our colleagues at the Lung Cancer Initiative at Johnson & Johnson with the goal of transforming the standard of care for this devastating disease.”
Ethicon continues to generate clinical evidence with the December 2019 launch of the TARGET trial, a prospective multicenter study to further characterize the safety and efficacy of the MONARCH Platform.
*Comprising the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment
**Dr. Chen and Dr. Silvestri are paid consultants for Auris Health, Inc.