Spot Ex Endoscopic Tattoo Receives CE Mark - Launches in Europe
(6 days ago)
LONDON: GI Supply, Inc. announced today that its Spot Ex Endoscopic Tattoo received CE Mark and is now available in Europe. Spot Ex is used to endoscopically mark cancerous tissue, suspicious lesions and polyps for easier future identification at follow-up colonoscopy procedure or surgery.
It is the only endoscopic tattoo to have a long-term clinical surveillance indication that empowers gastroenterologists to implement the new ESGE guidelines.
"Advances in screening and therapy are helping reduce colon cancer death rates across Europe. Polypectomy and EMR are now common skills for gastroenterologists, and allow patients to get cancer cured without the need for traditional surgery," said Professor Cesare Hassan, Head of Endoscopy Unit at Nuovo Regina Margherita Hospital in Rome. "The new ESGE guidelines formulated by the most worldwide recognized experts recommend long‐term follow‐up of patients who had these procedures to detect and treat recurrences in order to reduce the risk of interval cancer." Professor Hassan further added, "I'm very happy to have Spot Ex because it's the only tattoo indicated for long-term clinical surveillance."
The new ESGE guidelines recommend tattooing all lesions that need to be followed-up at future colonoscopy or surgery (Ferlitsch 2017). Spot Ex is the only endoscopic tattoo with a long-term clinical surveillance indication.
The new Spot Ex formulation is also much darker than the current Spot product, making the tattoo easier-to-find and helping endoscopists and surgeons manage time and productivity pressures. Two new clinical studies were conducted to verify 100% visibility of Spot at follow-up procedures up to 11 years later. (Cano 2017 and Jackson 2017).
"Our mission at GI Supply is to help more GI physicians do more advanced endoscopic procedures safely and efficiently, and Spot Ex is a great next step in meeting those needs," said Luke Johnson, CEO of GI Supply. "We're happy to expand the availability of Spot Ex into Europe and provide clinicians with the next step in the fight against colon cancer."