US FDA Encourages Close Look At Safety Of Emphysema Device
Executive Summary
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FDA Panel: Benefits Unproven For BTG Emphysema Treatment
An US FDA advisory panel wasn't convinced by data for BTG/PneumRX’s Elevair Endobronchial Coil System during a June 14 meeting. The panel decided that while the emphysema device was reasonably safe, the sponsor hadn’t shown it was effective or that the benefits outweighed the risks.
Market Intel: Promising Data At ATS2018 Inflate Hopes For Endobronchial Valves And New Device-Based COPD Therapies
Chronic obstructive pulmonary disease (COPD) is a widespread, progressive lung disease for which pulmonologists in the US have had few new treatment options available outside the standard pharmacological therapies, lung rehabilitation and high-risk lung volume reduction surgery. Now emerging technologies, in particular, endobronchial valves, which aim to shrink hyperinflated lungs in severe emphysema patients, could soon become the first minimally invasive treatment option available in the US. New study results, presented at this year's annual American Thoracic Society International Conference in San Diego, helped built momentum among US-based clinicians to extend upon their therapeutic arsenal for patients for devices that have already been widely used in Europe. This article discusses study findings presented at ATS, including a new cost-comparison analysis for treating COPD patients at home using non-invasive ventilation and oxygen therapy. We'll also discuss the latest innovative technologies for COPD patients presented at ATS and provide insights from leading experts on factors they think will drive treatment options forward.
BTG Heads To Panel Next Month For Emphysema Device
A PMA for the PneumRx ELEVAIR endobronchial coil system will be considered by a US FDA advisory panel in June, but there will likely be some questions about the data.