The Monarch Platform was cleared by the FDA in March 2018 for diagnostic and therapeutic bronchoscopic procedures.
The study was set up to test the safety and feasibility of performing robotic-assisted bronchoscopy in consecutive patients with lung nodules referred for bronchoscopic biopsy. Between June and October last year, 82 procedures were performed with the Monarch system at the University of Chicago Medicine, University of Pittsburgh Medical Center Hamot and Fox Chase Cancer Center.
The researchers reported that although most of the lesions were less than three centimeters in size and found in the outer third of the lung, researchers were able to reach them in 94% of the cases. Dr. Kyle Hogarth, director of bronchoscopy at the University of Chicago Medicine, reported that the biopsies performed with the Monarch system had complication rates similar to existing guided bronchoscopy platforms.
“These interim results, from the largest multi-institutional ongoing study using the Monarch Platform, show that the system successfully overcomes limitations of the reach of conventional bronchoscopic systems,” Hogarth said in prepared remarks.
“The Monarch Platform was designed to travel deep into the lungs and precisely guide a biopsy instrument into even the most difficult nodules, while continuously maintaining vision,” Eric Davidson, VP of sales & marketing at Auris Health, added. “These positive results follow preliminary encouraging results from the ongoing Benefit study reported earlier this week, demonstrating the potential of the Monarch Platform to help diagnose hard-to-reach lesions.”
Johnson & Johnson made its first play in the robotic surgery market in February this year when it picked up Auris Health for $3.4 billion.
Auris Health’s Monarch system includes a controller interface used to navigate the integrated flexible robotic endoscope into the periphery of the lung. The technology also reportedly combines traditional endoscopy views with computer-assisted navigation based on 3D patient models.