Johnson & Johnson (NYSE:JNJ) subsidiary Auris Health said today that a study of its Monarch robot-assisted bronchoscopy device reached its primary effectiveness endpoint in nearly all procedures.
The Benefit study assessed the platform’s ability to aid in the diagnosis of peripheral pulmonary lesions ranging from 1cm to 5cm. The Monarch platform localized targeted nodules using direct visualization, navigational guidance and radial endobronchial ultrasound, according to a news release.
The Monarch Platform successfully located targeted pulmonary lesions in 52 of 54 (96.3%) procedures, meeting the primary effectiveness endpoint.
Pneumothorax occurred in two of the 55 (3.6%) procedures and tube thoracostomy was required in one procedure (1.8%). The study did not report additional serious adverse events.
Monarch was cleared by the FDA in March 2018 for diagnostic and therapeutic bronchoscopies. In May, Auris touted interim results from an independent feasibility study designed to assess the platform. In that study, in 82 procedures, researchers reported that although most of the lesions were less than 3cm in size the outer third of the lung, they were able to reach them in 94% of cases.
Since Monarch launched in 2018, more than 1,000 U.S. procedures have been performed, according to the company.
“The results from the Benefit study demonstrate the potential of Monarch to help surgeons diagnose these hard-to-reach lesions,” Auris COO Josh DeFonzo said in prepared remarks. “We are very encouraged by the results of the Benefit study and are thrilled to be making a positive impact on the diagnosis of lung conditions. We will continue to build robust clinical evidence around the Monarch platform to support its use in interventional pulmonology.”