UK-based Creo Medical has secured CE mark approval for its Speedboat Inject device for upper gastrointestinal (GI) use in Europe.
Earlier, the device received a CE mark for lower GI tract for use only within European markets but this new clearance allows the use of the device for endoscopic procedures through the complete GI tract, from the mouth down to the stomach, besides within the lower GI tract.
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It already secured approval for use in the full GI tract to cut and coagulate soft tissue using microwave energy and radiofrequency in the Asia-Pacific, the US and other regions across the world.
Creo Medical CEO Craig Gulliford said: “We are really excited by this extension to the clearance in Europe which opens up increases in case volume for a significant number of our customers with usage to treat a wide number of additional indications.
“This clearance opens up possibilities not only to increase the caseloads of existing users but primarily to introduce Speedboat to a large base of new users.”
When utilised for soft tissue cutting and coagulation, Speedboat Inject has been used to carry out procedures such as oesophagus per-oral endoscopic myotomy (POEM) for treating achalasia and Gastric per-oral endoscopic myotomy (G-POEM) to treat delayed gastric emptying.
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By GlobalDataIt is also used in the Z-POEM procedure to treat Zenkers diverticulum, as well as the F-POEM procedure to lower reflux.
Furthermore, the device is used in Speedboat Submucosal Dissections (SSD) in the oesophagus and stomach, to resect certain pre-cancerous and cancerous lesions endoscopically.
