7th Jan 2021 10:11
(Alliance News) - Creo Medical Group PLC on Thursday announced it has received clearance for its tissue ablation device MicroBlate Flex from the US Food & Drug Administration.
The Chepstow, Wales-based surgical endoscopy company said its MicroBlate Flex device, which is designed to ablate nodules and tumours in several soft tissue types such as the lung, is the fourth device within its flexible endoscopy portfolio to receive FDA regulatory clearance, and paves the way for the device to be rolled out into the US market.
The device has the potential to treat a range of ears, nose and throat indications, including nasopharyngeal cancer and nasal polyps, where a small diameter flexible device enables access into otherwise inaccessible regions of the body, Creo added. It was cleared under section 510 (k) of the Food, Drug & Cosmetic Act.
The company's other ablation product, MicroBlate Fine, also received 510 (k) clearance from the FDA back in November, and its first in-man clinical use was announced in December.
"We are delighted to receive FDA clearance for the MicroBlate Flex device and we remain focused on completing our programme of regulatory clearances for the full suite of advanced energy surgery products for the flexible endoscopy market. We expect to see further first clinical use of our products in various markets and we look forward to utilising our enhanced global sales and marketing capability to drive commercialisation of our range," said Chief Executive Craig Gulliford.
Shares in Creo Medical were up 3.2% at 200.20 pence in London on Thursday.
By Zoe Wickens; [email protected]
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