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  • Positive results from BENEFIT study for MONARCH Pl...

Positive results from BENEFIT study for MONARCH Platform diagnostic and therapeutic bronchoscopic procedures. Auris Health/Ethicon/J&J

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Published:22nd Jan 2021
Auris Health, Inc., a subsidiary of Ethicon, Inc., part of the Johnson & Johnson Medical Devices Companies, 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. 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. See-"Robotic Bronchoscopy for Peripheral Pulmonary Lesions A Multicenter Pilot and Feasibility Study (BENEFIT)"- Alexander C. Chen, MD; Nicholas J. Pastis Jr, MD; Amit K. Mahajan, MD; Sandeep J. Khandhar, MD; Michael J. Simoff, MD; Michael S. Machuzak, MD; Joseph Cicenia, MD; Thomas R. Gildea, MD; and Gerard A. Silvestri, MD.-Originally published Online First Available online 19 August 2020.
Condition: Robotic Bronchoscopy
Type: drug

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