May 21 2019
Redwood City, Calif. and Dallas – May 21, 2019 – Auris Health, Inc., part of Johnson & Johnson Medical Devices Companies,* today announced that interim results from an independent pilot feasibility study designed to evaluate the company’s Monarch Platform were presented at the American Thoracic Society (ATS) 2019 Conference in Dallas. The Monarch Platform is a first-of-its-kind robotic technology cleared by the U.S. Food and Drug Administration (FDA) for diagnostic and therapeutic bronchoscopic procedures.
The objective of this study was to evaluate the safety and feasibility of performing robotic-assisted bronchoscopy in consecutive patients with lung nodules referred for bronchoscopic biopsy. Eighty-two procedures were conducted with the Monarch Platform between June and October 2018 at the University of Chicago Medicine, University of Pittsburgh Medical Center (UPMC) Hamot, and Fox Chase Cancer Center.
“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,” said D. Kyle Hogarth, M.D., FCCP, associate professor of medicine, director of bronchoscopy at the University of Chicago Medicine. “Though the majority of these lesions were less than three centimeters in size and located in the outer third of the lung, we were able to reach them in 94% of the cases. The biopsies were safely performed with complication rates similar to existing guided bronchoscopy platforms.”
“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,” said Eric Davidson, vice president, sales and marketing at Auris Health. “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.”
Lung cancer is the number one cancer killer of both men and women in the world. In the United States, approximately 400 people die daily due to the disease . The development of new advanced technologies, like the Monarch Platform, could allow the opportunity to make an earlier diagnosis, potentially saving many lives as a result.
Authors of the study include Stephen Kovacs, D.O., F.C.C.P., Pulmonary and Critical Care, UPMC Hamot; Udit Chaddha, M.D., Pulmonary and Critical Care, University of Chicago; Christopher Manley, M.D., Pulmonary and Critical Care, Fox Chase Cancer Center; Manisha Shende, M.D., Cardiothoracic Surgery, UPMC Hamot; Septimiu Murgu, M.D., Pulmonary and Critical Care, University of Chicago; and D. Kyle Hogarth, M.D., F.C.C.P., Pulmonary and Critical Care, University of Chicago.
About Auris Health, Inc. Auris Health is pioneering the next era of medical intervention by developing platforms that enhance physician capabilities, evolve minimally invasive techniques, and create new categories of care that redefine optimal patient outcomes. The company is committed to transforming medical intervention by integrating robotics, micro-instrumentation, endoscope design, sensing, and data science into one platform. Every element of our technology is driven by patient-specific design aimed at maintaining the integrity of the human body. Learn more at www.aurishealth.com.
AURIS and MONARCH are trademarks and/or registered trademarks of Auris Health, Inc. in the United States and in other countries. All other trademarks and product names used herein are the property of their respective owners.
About Johnson & Johnson Medical Devices Companies As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics, vision and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life.
*Comprising the surgery, orthopaedics, vision and interventional businesses within the Johnson & Johnson’s Medical Devices segment
Dr. Kovacs, Dr. Manley, Dr. Murgu and Dr. Hogarth are paid consultants to Auris Health, Inc.
World Health Organization: https://www.who.int/cancer/PRGlobocanFinal.pdf
National Cancer Institute https://seer.cancer.gov/statfacts/html/lungb.html
Complications from bronchoscopy are rare and most often minor, but if they occur, may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. Only rarely do patients experience other more serious complications (for example, collapsed lung, respiratory failure, heart attack and/or cardiac arrhythmia).
Adverse effects from both Mini-PCNL and Ureteroscopy include pain, urinary tract infection, fever, hematuria (presence of blood in urine), exposure to low levels of radiation, retained or residual stones.
Adverse effects from ureteroscopy may include pain, perforation or injury to the ureter, resulting in extravasation of fluid and urine (urinoma), stricture of the ureter with risk of subsequent obstruction (hydronephrosis needing further repair), rare avulsion of the ureter, urinary blood clots, residual stones.
PCNL access may result in minor and major adverse effects. Minor effects include fever and nephrostomy leak. Major adverse effects may include injuries to pleura, liver, spleen, large vessels with related bleeding, gallbladder, duodenum, jejunum, colon with related cutaneous fistula, fever, pain, ileus, elevated counts.
Major adverse effects related to stone removal may include infection and urosepsis, intravascular fluid overload, extravasation of fluid, and post percutaneous nephrolithotomy bleeding.