BENEFIT Results Could Contain Spoilers for Monarch ’s Effectiveness

Johnson & Johnson’s Auris Health scored positive preliminary results from a first-in-human study evaluating the Monarch Platform to aid in the diagnosis of peripheral pulmonary lesions. Data from the BENEFIT study was presented at the American Thoracic Society 2019 Conference in Dallas. So far in BENEFIT, Monarch has been used in 24 patients to localize targeted nodules using a combination of direct visualization, navigational guidance and radial endobronchial ultrasound. The primary effectiveness endpoint, successful localization of targeted pulmonary lesions confirmed using a radial endobronchial ultrasound probe, has been reported in 92% of cases, with no significant adverse events. In a release, Alexander C. Chen, M.D., of St. Louis, Mo, and principal investigator for BENEFIT said, "Early results from this ongoing study have shown that the Monarch Platform has the ability to successfully reach, localize and biopsy peripheral pulmonary lesions in live human subjects. These preliminary findings follow the successful REACH and ACCESS studies, which demonstrated that the platform improved reach beyond a conventional thin bronchoscope and can biopsy peripheral lesions with high accuracy in cadaveric lungs.” But are the results a preview of how the technology could diagnose pulmonary lesions? Keep in mind that Monarch has already successfully received FDA clearance for diagnostic and therapeutic bronchoscopic procedures. Josh DeFonzo, COO...
Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news