Medtronic’s Endoflip 300 System Gains CE Mark

Medtronic announced that it has received CE Mark approval for its next-generation Endoflip 300 system to measure pressure and dimensions in the esophagus and pylorus in adults. Endoflip can be performed under sedation in around 5 minutes and can be used from the very first endoscopy.¹

The Endoflip 300 System aims to help thousands of patients across Europe with esophageal motility disorders achieve a diagnosis.² Research suggests these disorders are missed in up to 50% of endoscopies, and patients can wait years to receive a diagnosis.³

“Medtronic is committed to transforming esophageal care for patients by providing physicians with cutting-edge solutions to their clinical challenges,” commented Darin Wilson, Medtronic Endoscopy Business Unit Leader, Western Europe. “We are excited to have received CE Mark approval for Endoflip 300, which will help gastroenterologists & GI surgeons across Europe diagnose esophageal motility disorders much earlier, plan and implement precise and effective treatment, and, ultimately, improve patient outcomes. We are fueled by our resolve to change each individual’s life for the better and strive to achieve this through continued technological innovation.”  

The Endoflip 300 device uses a balloon catheter to display diameter estimates of the measurement area in real time. It can measure and display diameter estimates at up to 16 points within the balloon while also displaying balloon pressure.⁴ This may allow for a more precise diagnosis and treatment planning from the very first endoscopy, preventing unnecessary distress for patients.^2,5

Dr. Rehan Haidry, Clinical Lead of Endoscopy and Consultant Gastroenterologist at the Cleveland Clinic, London adds: “Endoflip is a game changer for us. Esophageal motility disorders, like achalasia and gastroparesis, are notorious for being hard to spot and patients are often given the wrong diagnosis. I’ve seen patients with symptoms for over a decade, undergoing numerous inconclusive endoscopies.  Endoflip provides us with a significant advantage: by guiding diagnosis and treatment early on, Endoflip can drastically improve patient outcomes.”  

Key Endoflip benefits

• Comfortable – can be performed under sedation¹
• Fast – Can take around 5 minutes ¹
• Can be performed at the time of endoscopy²
• Can facilitate clinical diagnosis to direct management ⁶
• Real time topography is displayed clearly on a screen alongside well established ranges^2,4
• Physicians trained in Endoflip may be able to make a diagnosis during the endoscopy⁴
• Indicated for adult patients (18+)

The Endoflip 300 System will be commercially available in Europe in the coming months and has already been cleared for sale or distribution in the United States.

References:

¹ Donnan EN, Pandolfino JE. EndoFLIP in the Esophagus: Assessing Sphincter Function, Wall Stiffness, and Motility to Guide Treatment. Gastroenterol Clin North Am. 2020 Sep;49(3):427-435. doi: 10.1016/j.gtc.2020.04.002. Epub 2020 Jun 14. PMID: 32718562; PMCID: PMC7387752.

² Carlson DA, Kahrilas PJ, Lin Z, Hirano I, Gonsalves N, Listernick Z, Ritter K, Tye M, Ponds FA, Wong I, Pandolfino JE. Evaluation of Esophageal Motility Utilizing the Functional Lumen Imaging Probe. Am J Gastroenterol 2016;111(12):1726-1735.

³ Richter, J. E. The Diagnosis and Misdiagnosis of Achalasia: It Does Not Have to Be so Difficult, Volume 9, Issue 12, Published:June 22, 2011DOI:https://doi.org/10.1016/j.cgh.2011.06.012

⁴ Medtronic: Endoflip™ 300 Operator’s Manual (Data on file)

⁵ Ahuja NK, Agnihotri A, Lynch KL, Hoo-Fatt D, Onyimba F, McKnight M, Okeke FC, Garcia P, Dhalla S, Stein E, Pasricha PJ, Clarke JO. Esophageal distensibility measurement: impact on clinical management and procedure length. Dis Esophagus. 2017 Aug 1;30(8):1-8. doi: 10.1093/dote/dox038. PMID: 28575249

⁶ Carlson DA, Prescott JE, Baumann AJ, Schauer JM, Krause A, Donnan EN, Kou W, Kahrilas PJ, Pandolfino JE. Validation of Clinically Relevant Thresholds of Esophagogastric Junction Obstruction Using FLIP Panometry. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1250-e1262.