Monday, June 19, 2023
Creo Medical has announced today that Speedboat Inject has received CE marking under the Medical Device Regulation (MDR) for use in the entire gastrointestinal (GI) tract, following upper GI clearance.
Previously, Speedboat Inject was CE marked solely for lower GI tract use within European markets. The recent clearance now permits the device to be utilized for endoscopic procedures throughout the entire GI tract, encompassing the upper GI tract from the mouth to the stomach, as well as the lower GI tract. In the United States, APAC, and other regions, Speedboat Inject is already approved and employed for cutting and coagulation of soft tissue using radiofrequency (RF) and microwave energy in the full GI tract.
Speedboat Inject has demonstrated its efficacy in various medical procedures involving the cutting and coagulation of soft tissue. These procedures include:
1. Oesophagus per-oral endoscopic myotomy (POEM): This technique is employed to treat achalasia, a swallowing disorder. Speedboat Inject offers a less invasive alternative to the traditional heller myotomy surgery typically required.
2. Gastric per-oral endoscopic myotomy (G-POEM): G-POEM is used to address gastroparesis, a condition characterized by delayed gastric emptying. Speedboat Inject enables physicians to perform this procedure with improved precision.
3. Z-POEM: This procedure is utilized to treat Zenker's diverticulum, a condition where a pouch or pocket forms in the esophageal wall, affecting swallowing and throat function. It is commonly performed by ear, nose, throat (ENT) and foregut surgeons and is considered a prominent procedure.
4. F-POEM: F-POEM, a derivative of Oesophagus POEM, aims to reduce reflux. Previously, invasive upper GI surgical procedures were necessary, but Speedboat Inject provides a less invasive alternative.
5. Speedboat Submucosal Dissections (SSD): SSD is employed to endoscopically resect certain cancerous and pre-cancerous lesions in the stomach and esophagus. It has proven to be an effective method for their removal.
In FDA-regulated regions, upper GI cases account for more than 40% of all Speedboat procedures performed worldwide. Creo Medical has a strong pipeline of clinicians in Europe who are ready to use the device for upper GI procedures. Demonstrations, training, and planned procedures are already underway.