Creo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces that it has received 510(k) clearance from the US Food & Drug Administration (‘FDA’) for its tissue ablation device MicroBlate™ Flex.
MicroBlate™ Flex is the fourth device within Creo’s portfolio of flexible endoscopy devices for the gastrointestinal (‘GI’) market to receive FDA regulatory clearance, alongside CE marking already received across the range in 2020. The first Creo product to receive FDA clearance, Speedboat™ Inject, is being used by clinicians in the UK, EU, US, South Africa and APAC.
Creo’s suite of devices have been designed to be used with the CROMA Advanced Energy Platform, powered by Kamaptive™ full-spectrum adaptive technology, a seamless, intuitive integration of multi-modal energy sources, optimised to adapt to the tissue effect required for different procedures such as resection, dissection, coagulation and ablation.
About MicroBlate™ Flex
Creo’s MicroBlate™ tissue ablation technology utilises Creo’s very high frequency microwave energy allowing physicians to precisely ablate diseased tissue in multiple organ types and many different clinical access methods. MicroBlate™ Flex is an additional soft tissue ablation device within the range, designed to ablate nodules and tumours in several soft tissue types, including the lung. MicroBlate™ Flex has potential to treat a number of other conditions, where a small diameter flexible device enables access into otherwise inaccessible regions of the body. MicroBlate™ Flex could be particularly useful to treat a range of ENT indications, including nasopharyngeal cancer and nasal polyps.
Creo’s additional ablation product, MicroBlate™ Fine also received 510(k) clearance from the FDA in November 2020 and the first in-man clinical use of MicroBlate™ Fine was announced in December 2020. FDA clearance paves the way for the roll-out of these devices into the US market and with the full range of products CE marked during 2020 Creo also has access to the EU and UK markets enabling commercialisation of the GI suite.
Craig Gulliford, Chief Executive Officer, commented:
We are delighted to receive FDA clearance for the MicroBlate™ Flex device and we remain focussed 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.
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