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Speedboat Inject upper GI clearance in Europe
Speedboat Inject upper GI clearance in Europe.
About this update from Creo Medical Group Plc
[{"type":"text","content":"\n\n \n\nCreo Medical Group plc\n(\"Creo\" the \"Company\" or the \"Group\")\n \nSpeedboat Inject cleared for upper GI use in Europe\n \nCreo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces that Speedboat Inject is now CE marked according to the Medical Device Regulation (\"MDR\") for use throughout the entire gastrointestinal (\"GI\") tract, having received upper GI clearance.\n \nUntil now, Speedboat Inject has been CE marked for lower GI tract use only within European markets. Clearance for upper GI procedures mean that the device can now be used for endoscopic procedures through the whole of the GI tract, from the mouth down to the stomach (upper GI tract) as well as within the lower GI tract. Speedboat Inject is already cleared and used in the full GI tract for the cutting and coagulation of soft tissue using radiofrequency (RF) and microwave energy in the US, APAC and elsewhere.\n \nWhen used as indicated for the cutting and coagulation of soft tissue, Speedboat Inject has been used to perform procedures such as:\n \n· Oesophagus per-oral endoscopic myotomy (\"POEM\") to treat achalasia (a swallowing disorder), where typically a heller myotomy (surgery) would be required;\n· Gastric per-oral endoscopic myotomy (G-POEM) to treat delayed gastric emptying (gastroparesis);\n· Z-POEM to treat Zenkers diverticulum, where a pouch or pocket that forms in the wall of the oesophagus, affecting the throat and swallowing process, and is a prominent procedure for ear, nose, throat (ENT) and foregut surgeons;\n· F-POEM, a derivative of Oesophagus POEM, to reduce reflux - typically this has required an invasive upper GI surgical procedure; and\n· Speedboat Submucosal Dissections (\"SSD\") in the stomach and oesophagus, to endoscopically resect certain cancerous and pre-cancerous lesions.\n \nIn FDA regions, upper GI cases account for over 40% of global Speedboat procedures to date. Creo Medical already has a healthy pipeline of clinicians ready to use the device for upper GI procedures across Europe, with demonstrations, training and procedures already planned in.\n \nCraig Gulliford, Chief Executive Officer of Creo Medical, commented: \"We are reall...