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First European Speedboat® UltraSlim procedure

First European Speedboat® UltraSlim procedure.

articleCreo Medical Group PlcDecember 13, 20234/company/creo-medical-group-plc/news/first-european-speedboatr-ultraslim-procedure
First European Speedboat® UltraSlim procedure

About this update from Creo Medical Group Plc

[{"type":"text","content":"\n\n\n\n\n\nCreo Medical Group plc\n(\"Creo\" the \"Company\" or the \"Group\")\n \nFirst European Speedboat® UltraSlim procedure marks early commercial launch\n \nCreo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces the initiation of its commercial launch of Speedboat® UltraSlim, following the completion of the design transfer to manufacturing last week. The first procedure using the device was completed in the UK.\n \nThis first use of Speedboat® UltraSlim was for a lower Gastrointestinal (\"GI\") tract procedure, and comes shortly after the Company announced the UK and EU regulatory pathway had been accelerated by approximately 18 months. The Company expects the first European upper GI cases to follow soon, as well as first upper and lower GI cases in the USA, following the 510(k) clearance being received from the US Food & Drug Administration in November 2023.\n \nSpeedboat® UltraSlim is the third device in Creo's Speedboat® family of products. The device is the culmination of a long programme of work to miniaturise the technology to a scale which covers all the foreseeable market applications, resulting in blanket compatibility with all commercial endoscopes accessing the vast majority of GI endoscopic procedures and significantly increasing the opportunity for more clinicians and patients to benefit from Creo's cutting-edge technology.\n \nSpeedboat® UltraSlim is targeting the therapeutic treatment of disease in the GI tract including cancer of the Bowel, Stomach and Oesophagus as well as surgical procedures to deal with abnormalities resulting in swallowing disorders and in some cases gastric reflux. Powered by Creo's CROMA advanced energy platform, Speedboat® UltraSlim delivers advanced bipolar radiofrequency (\"RF\") energy for controlled cutting and high frequency microwave (\"MW\") energy for controlled coagulation of tissue in the GI tract.\n \nCraig Gulliford, Chief Executive Officer of Creo Medical, said: \"This is yet another landmark moment for Creo Medical. We know what a difference this even smaller device will make in terms of broadening access to advanced energy in endoscopy for a wider pool of clinicians. Speedboat UltraSlim is compatible with all major endoscopes, meaning clini...

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