Creo Medical Group PLC (AIM:CREO) said its Speedboat Inject device has been given the green light for use in upper gastrointestinal (GI) procedures throughout Europe, marking a significant expansion of its capabilities in the region.
Previously, the device was only approved for lower GI tract use within European markets. Now, doctors can utilise Speedboat Inject to perform endoscopic procedures throughout the entire GI tract, from mouth to stomach.
This comes as a game-changer for patients suffering from a range of GI disorders such as achalasia, delayed gastric emptying, and Zenkers diverticulum.
Speedboat Inject provides a less invasive alternative to conventional surgeries, potentially offering quicker recovery times and less risk.
The device is already used extensively in the US, APAC, and other regions, where over 40% of all Speedboat procedures are performed on the upper GI tract.
Now European clinicians are revving up to embrace this novel technology, with numerous demonstrations, training sessions, and procedures already scheduled. It's full steam ahead for Creo Medical as they chart a new course for endoscopic procedures across Europe.
"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," said Creo chief executive Craig Gulliford in a statement.
"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," he added.