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.
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Complications with inferior vena cava (IVC) filters and subsequent patient-injury lawsuits have made this a tricky space for medical technology innovators, but BTG has not been deterred. The UK company has entered the fray with a technology developed by Novate Medical, and as a bioconvertible product BTG believes it has key advantages compared with other offerings.
The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.