What Does Medtronic’s CE Mark Approval for the Endoflip System Mean for Patients?

Highlights

• Medtronic has received CE Mark approval for its next-generation Endoflip 300 system for oesophageal diagnostics
• The Endoflip 300 System helps diagnose oesophageal motility disorders in patients across Europe

Medtronic has announced that it has received CE Mark approval for its next- generation , designed to measure pressure and dimensions in the oesophagus and pylorus in adults.

Medtronic claims that the Endoflip 300 System has the potential to assist thousands of patients across Europe in diagnosing oesophageal motility disorders. The company highlights research indicating that these disorders are often overlooked in up to 50% of endoscopies, leading to patients waiting years for a diagnosis. The Endoflip procedure, which can be completed in approximately five minutes under sedation, can be used during the initial endoscopy for immediate results.

Timely diagnosis of these conditions is crucial for enhancing patient outcomes. Since identifying the root cause of symptoms can be challenging, Endoflip serves as a valuable tool, offering a convenient and well-tolerated method for assessment.

The device employs a balloon catheter to deliver immediate diameter measurements of the targeted region. It is capable of assessing and showing diameter approximations at as many as 16 locations within the balloon, along with the pressure inside the balloon. This feature enables more accurate diagnosis and treatment planning right from the initial endoscopy, helping to minimise unnecessary patient discomfort.

Darin Wilson, Head of Medtronic’s Endoscopy Business Unit for Western Europe, shared, “Medtronic is dedicated to transforming oesophageal care by equipping healthcare providers with state-of-the-art solutions to address clinical challenges. We are excited to announce the CE Mark approval for the Endoflip 300, a groundbreaking advancement that empowers gastroenterologists and GI surgeons throughout Europe to detect oesophageal motility disorders at an earlier stage, develop targeted treatment plans, and significantly improve patient outcomes. Our commitment to improving lives fuels our continuous drive for advancements in healthcare technology.”

Dr. Rehan Haidry, Clinical Lead of Endoscopy and Consultant Gastroenterologist at the Cleveland Clinic, London, stated: “Endoflip is a breakthrough tool for us. Oesophageal motility disorders, such as achalasia and gastroparesis, are notoriously difficult to diagnose, often leading to misdiagnoses. I’ve encountered patients with symptoms spanning over a decade, undergoing multiple inconclusive endoscopies. Endoflip gives us a critical edge by enabling early diagnosis and treatment, which can significantly enhance patient outcomes.”

Professor Silvana Perretta, an upper gastrointestinal surgeon at the Nouvel Hôpital Civil (NHC) University Hospital in Strasbourg, stated: “The integration of Endoflip technology for perioperative use adds a valuable functional tool that enhances diagnostic accuracy, helping to prevent misdiagnosis and subsequent mistreatment. This innovation is crucial in providing more precise care, especially in the era of precision surgery and treatment. A smart imaging probe for accurate diagnosis can reduce healthcare costs and significantly improve patient outcomes.”

Key benefits of Endoflip as per Medtronic:

● Performed with sedation for patient ease
● Takes approximately 5 minutes
● It can be performed simultaneously with an endoscopy procedure
● Aids clinical diagnosis and guides treatment decisions
● Displays real-time topography on screen with established reference ranges
● Trained physicians using Endoflip may provide a diagnosis during the procedure itself
● Approved for adult patients (18+)