CE Mark for new GI motility testing system

Image source: © Medtronic

The company hopes that the new system will help thousands of patients across Europe with oesophageal motility disorders achieve a diagnosis.¹ Research suggests these disorders are missed in up to 50% of endoscopies and patients can wait years to receive a diagnosis.² Endoflip can be performed under sedation in around five minutes and can be utilised from the very first endoscopy.³

Timely diagnosis of these conditions is key to improving patient outcomes.⁴ As pinpointing the underlying cause of patient symptoms can be very difficult, Endoflip represents a valuable tool as a convenient, well tolerated method for assessment.¹^,5-9 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.¹⁰ This may allow for a more precise diagnosis and treatment planning from the very first endoscopy, preventing unnecessary distress for patients.¹^,⁷

“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 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 provides us with a significant advantage: by guiding diagnosis and treatment early on, Endoflip can drastically improve patient outcomes.”

Professor Silvana Perretta, Upper gastro-intestinal surgeon, from the Nouvel Hôpital Civil (NHC) University Hospital, Strasbourg, concludes: “Incorporating Endoflip 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.⁹ 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.²^,11-13 This is because symptoms can overlap with more common conditions such as gastro-oesophageal reflux disease (GORD).

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. Meanwhile, patients deteriorate and they suffer reduced quality of life due to ongoing symptoms⁹.

Key benefits of Endoflip:

Comfortable – can be performed under sedation³
Fast – Can take around 5 minutes³
Can be performed at the time of endoscopy¹
Can facilitate clinical diagnosis to direct management
Real time topography is displayed clearly on a screen alongside well established ranges¹^,⁷
Physicians trained in Endoflip may be able to make a diagnosis during the endoscopy³
Indicated for adult patients (18+)

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

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