Medtronic receives CE Mark for its next generation Endoflip TM 300 system

Medtronic receives CE Mark for its next generation Endoflip ^TM 300 system

Endoflip ^TM is an advanced diagnostic tool that can help expedite accurate diagnosis of oesophageal motility disorders, conditions often missed during endoscopies.[1]^,[2]

DUBLIN – 15 November 2024 – Medtronic plc, a global leader in healthcare technology, today announced it has received CE Mark approval for its next generation Endoflip^TM 300 system to measure pressure and dimensions in the oesophagus and pylorus in adults.[3] The Endoflip^TM 300 System will help thousands of patients across Europe with oesophageal 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.¹ Endoflip^TM can be performed under sedation in around 5 minutes and can be utilised from the very first endoscopy.[4]

Timely diagnosis of these conditions is key to improving patient outcomes.[5]  As pinpointing the underlying cause of patient symptoms can be very difficult, Endoflip^TM represents a valuable tool as a convenient, well tolerated method for assessment.^2,[6]-9 The 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^.3 This may allow for a more precise diagnosis and treatment planning from the very first endoscopy, preventing unnecessary distress for patients.^2,8

 “Medtronic is committed to transforming oesophageal care for patients by providing physicians with cutting-edge solutions to their clinical challenges,” comments 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 oesophageal motility disorders much earlier, plan and implement precise and effective treatment and, ultimately, improve patient outcomes. We are fuelled by our resolve to change each individual’s life for the better and strive to achieve this through continued technological innovation.” 

Dr. Rehan Haidry, Clinical Lead of Endoscopy and Consultant Gastroenterologist at the Cleveland Clinic, London adds: “Endoflip^TM is a game changer for us. Oesophageal 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^TM provides us with a significant advantage: by guiding diagnosis and treatment early on, Endoflip^TM can drastically improve patient outcomes.”  

Professor Silvana Perretta, Upper gastro-intestinal surgeon, from the Nouvel Hôpital Civil (NHC) University Hospital, Strasbourg concludes: “Incorporating Endoflip^TM technology for perioperative use provides an additional functional tool that enhances diagnostic accuracy and helps prevent misdiagnosis and therefore mistreatment. In surgery there is no room for approximation. This innovation is pivotal in delivering more precise care, particularly in the era of precision surgery and treatment. A smart imaging probe for smart diagnosis can save health care dollars and improve patient’s lives”.

Oesophageal motility disorders affect the normal functioning of the oesophagus. They can disrupt the normal swallowing process (peristalsis) causing symptoms such as difficulty swallowing (dysphagia), chest pain, regurgitation, and heartburn.10 The best-defined oesophageal motility disorder, achalasia, is rare with a prevalence of up to 15.7 per 100,000, while gastroparesis has a prevalence of 13.8 per 100,000 in Europe.11,12 But these conditions are misdiagnosed in up to 50% of endoscopies meaning, in Europe alone, there could be thousands more people living with these conditions that haven’t been diagnosed. ^1,11-13 This is because symptoms can overlap with more common conditions such as gastro-oesophageal reflux disease (GORD).14

Misdiagnosis can lead to unnecessary tests which can cause distress and cost money. Depending on the healthcare system and whether procedures are performed publicly or privately costs can vary, however, upper GI endoscopies typically cost €2,000 - €4,000 in Western Europe, and sometimes as much as €7,000.¹⁵  Meanwhile, patients deteriorate and they suffer reduced quality of life due to ongoing symptoms10.

Key benefits of Endoflip^TM:

• Comfortable – can be performed under sedation⁴
• Fast – Can take around 5 minutes⁴
• Can be performed at the time of endoscopy2
• Can facilitate clinical diagnosis to direct management16
• Real time topography is displayed clearly on a screen alongside well established ranges2,8
• Physicians trained in Endoflip^TM may be able to make a diagnosis during the endoscopy⁴
• Indicated for adult patients (18+)

The Endoflip^TM 300 System will be commercially available in the coming months and has already been cleared for sale or distribution in the United States. Visit https://www.medtronic.com/covidien/en-gb/products/motility-testing/endoflip-impedance-planimetry-system.html for more information.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow on LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

[1] 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

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

[4] 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.

[5]J M Wilkinson, Esophageal Motility Disorders, Am Fam Physician. 2020;102(5):291-296 https://www.aafp.org/pubs/afp/issues/2020/0901/p291.html

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. doi: 10.1016/j.cgh.2021.06.040. Epub 2021 Jun 30. PMID: 34216821; PMCID: PMC8716679

1. 7. Hirano, Ikuo, John E. Pandolfino, and Guy E. Boeckxstaens. “Functional lumen imaging probe for the management of esophageal
2. 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
3. Carlson DA, Gyawali CP, Kahrilas PJ, Triggs JR, Falmagne S, Prescott J, Dorian E, Kou W, Lin Z, Pandolfino JE. Esophageal motility classification can be established at the time of endoscopy: a study evaluating real-time functional luminal imaging probe panometry. Gastrointest Endosc. 2019 Dec;90(6):915-923.e1. doi: 10.1016/j.gie.2019.06.039. Epub 2019 Jul 4. PMID: 31279625; PMCID: PMC6875629.
4. D. A. Patel et al. Esophageal Motility Disorders: Current Approach to Diagnostics and Therapeutics, https://www.gastrojournal.org/article/S0016-5085(22)00197-4/fulltext (Accessed: February 2024)
5. Oude Nijhuis, European guidelines on achalasia: United European Gastroenterology and European Society of Neurogastroenterology and Motility recommendations. United European Gastroenterol J. 2020 Feb;8(1):13-33. doi: 10.1177/2050640620903213. PMID: 32213062; PMCID: PMC7005998.
6. M. Camilleri, Gastroparesis: Etiology, clinical manifestations, and diagnosis, Aug 15, 2022. https://www.uptodate.com/contents/gastroparesis-etiology-clinical-manifestations-and-diagnosis
7. https://www.worldometers.info/world-population/europe-population/ (Accessed: April 2024)