Business
First use of Speedboat® UltraSlim in the USA
First use of Speedboat® UltraSlim in the USA.
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 \nFirst use of Speedboat® UltraSlim in the USA\n \nCreo Medical Group plc (AIM: CREO), the medical device company focused on the emerging field of surgical endoscopy, announces that its latest device, Speedboat® UltraSlim, has now been successfully used in the USA.\n \nThe limited market release of the Speedboat® UltraSlim in the USA has resulted in the device being successfully used in multiple clinical applications. The first was a Speedboat Submucosal Dissection (SSD) in the colon for a precancerous lesion, followed by a precancerous resection in the oesophagus. Additional successful indications were Upper Oesophageal Peroral Endoscopic Myotomy and Zenkers Diverticulum, treating swallowing disorders and gastroparesis. These procedures come shortly after the Company announced that it had obtained 510(k) clearance from the US Food & Drug Administration for Speedboat® UltraSlim in November 2023 and follows the first UK case earlier this week.\n \nSpeedboat® UltraSlim is the third device in Creo's Speedboat® family of products, and 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. This latest generation Speedboat has broad application in the GI tract due to a smaller configuration, ensuring compatibility with a wide range of colonoscopes and gastroscopes.\n \nPowered by Creo's CROMA advanced energy platform, Speedboat® UltraSlim delivers fluid as well as advanced bipolar radiofrequency (\"RF\") energy for controlled cutting and high frequency microwave (\"MW\") energy for controlled coagulation of tissue in the GI tract. The device is the culmination of a long programme of work to further miniaturise Creo's technology, and is compatible with the working channel of all commercially available endoscopes accessing the vast majority of GI endoscopic procedures.\n \nCraig Gulliford, Chief Executive Officer of Creo Medical, said: \"Following the completion of the design transfer to manufacturing last week, the whole team has worked tirelessly to get Speedboat UltraSlim into the hands of clinicians. Having first use in t...