LONDON (Alliance News) - BTG PLC Monday said its PneumRx coil implant for patients with homogeneous or heterogeneous severe emphysema met all of its primary and secondary endpoints in its recent clinical study RENEW.
Additionally, the company received 510k clearance from the US Food and Drug Administration for its LC Bead LUMI, meaning it has permission to market the product. The LC Bead device is used to block abnormal blood vessels, for use in hypervascular tumours and arteriovenous malformations.
LC Bead LUMI, the latest iteration of this device, allows for real-time visible confirmation of the bead location.
"We are delighted with the successful outcome of RENEW, showing significant benefit in patients treated with the PneumRx Coils in one of the largest randomised controlled clinical trials of a medical device in patients with severe emphysema to date incorporating both patient reported and objective outcomes. We will now progress our regulatory application in the US, which we anticipate submitting around mid-2016," said BTG Chief Executive Officer Louise Makin in a statement.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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