Lumendi Receives CE Mark for DiLumen™ EZ and DiLumen™ C Devices
Lumendi AG, an innovator in advanced endoluminal technologies, has successfully secured CE certification for its cutting-edge DiLumen™ EZ and DiLumen™ C devices. This major achievement enables the company to begin commercial distribution within the European Union and other international markets, marking a significant enhancement in their product offerings.
Both devices are single-use, disposable endotherapy tools specifically designed for intricate colon procedures. Thenew offerings build upon the success of the previously established DiLumen EZ-Glide platform, which has been available in the U.S. market for two years. Their design enhancements promise not just effectiveness but also greater cost-efficiency, responding to the needs of modern healthcare.
The CE Mark signifies conformity with rigorous EU medical device regulations. Dr. Peter Johann, Executive Chairman of Lumendi AG, emphasized the importance of this certification, stating, "This milestone is a critical part of our strategy to broaden access to minimally invasive endoluminal procedures. Our collaboration with MICRO-TECH Endoscopy plays an important role in expanding our market reach as they distribute our devices across the U.K. and Ireland. Furthermore, we are expanding our network of independent distributors across Europe who are eager to launch our new technology."
Achieving CE certification is not only vital for Lumendi but essential for the medical community as well. It allows for free marketability throughout the European Economic Area, ensuring that healthcare professionals have access to the latest advancements. In fact, Lumendi has retained CE certification under the EU Medical Device Directive for the DiLumen EZ Glide since July 2018, and this current approval extends the certification to include the entire DiLumen product range under the revised EU 2017/745 Medical Device Regulation. Additionally, the company's commitment to quality is highlighted by its certification under ISO 13485:2016, which has been upheld since July 2017.
The DiLumen devices have already made a substantial impact in the field, with over 6,000 procedures completed worldwide. Multiple clinical studies and case reports have validated their safety, benefits, and cost-effectiveness, further embedding them into clinical practices.
The DiLumen™ EZ and DiLumen™ C are innovative single-use sleeves that integrate seamlessly with standard endoscopes. These devices enhance stability within the large intestine, improving visualization and precision for diagnostic and treatment purposes.
About Lumendi AG
Lumendi AG operates out of Zug, Switzerland, and is committed to advancing patient outcomes while simultaneously reducing healthcare costs. They focus on developing life-changing endoscopic solutions, demonstrating their dedication to patient care and innovative healthcare solutions. Lumendi LLC, located in Westport, CT, serves as a fully owned subsidiary of Lumendi AG.
For additional information about Lumendi and their pioneering devices, you can visit their official website and resources.
Frequently Asked Questions
What is the significance of the CE Mark for Lumendi's devices?
The CE Mark indicates that Lumendi's devices meet EU medical device regulations, allowing them to be marketed across the European Union.
How do the DiLumen™ EZ and C devices improve colon procedures?
These devices provide stabilization for standard endoscopes, improving access, visualization, and precision in complex colon procedures.
What has been the response to Lumendi's devices in clinical settings?
To date, over 6,000 procedures have utilized the DiLumen platform, supported by clinical studies demonstrating their safety and effectiveness.
What is Lumendi's commitment to quality assurance?
Lumendi has maintained its ISO 13485:2016 certification, ensuring a high standard of quality management in product development and manufacturing.
What future plans does Lumendi have for its devices?
Lumendi aims to expand its market presence through partnerships and to continue innovating in minimally invasive endoluminal technologies.
