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US FDA clearance for MicroBlateT Flex device
US FDA clearance for MicroBlateT Flex device.
About this update from Creo Medical Group Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 8285K\n Creo Medical Group PLC\n 07 January 2021\n \n \n \n \n \n \n \n Creo Medical Group plc\n \n \n (\"Creo\" or the \"Company\")\n \n \n \n \n \n \n US FDA clearance for \n \n \n MicroBlate\n \n \n ™\n \n \n Flex \n \n devic\n e\n \n \n \n \n \n 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 \n Food & Drug Administration ('FDA') for its tissue ablation device MicroBlate\n \n ™\n \n \n Flex\n \n .\n \n \n \n \n \n \n MicroBlate™ Flex\n \n is the fourth device within Creo's portfolio of flexible endoscopy devices for the gastrointestinal ('GI') market\n \n 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.\n \n \n \n \n \n \n Creo's suite of devices have been \n designed to be used with \n 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.\n \n \n \n \n \n About MicroBlate™ Flex\n \n \n 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. \n \n MicroBlate™ Flex \n \n is an additional soft tissue ablation device within the range, designed to ablate nodules and tumours in several soft tissue types, including the lung. \n \n MicroBlate™ Flex\n \n 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\n \n ™ Flex\n \n could be particularly useful to treat a range of ENT indications, including nasopharyngeal cancer and nasal polyps. \n \n \n \n \n \n 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 Mi...