Lumendi Receives CE Mark for Enhanced Endoscopy Devices in Europe

Lumendi Receives CE Mark for DiLumen EZ1 and DiLumen C1

Lumendi AG, a prominent name in advanced endoluminal technologies, has successfully achieved CE certification for their latest devices, the DiLumen™ EZ1 and DiLumen™ C1. This certification signifies that these groundbreaking products can now be commercially distributed across the European Union (EU) and other international markets, marking a significant milestone in Lumendi's commitment to enhancing medical technology in Europe.

Having previously been available in the U.S. for two years, the DiLumen EZ1 and C1 are set to build upon the established success of the DiLumen EZ-Glide platform, which had already received CE certification. The new devices are designed with a more streamlined, cost-effective approach, aimed at improving patient outcomes during complex colon procedures.

Peter Johann, Ph.D., Executive Chairman of Lumendi AG, stated, "This certification is a crucial step in our global strategy to enhance access to minimally invasive endoluminal procedures. We will continue to strengthen our market presence through our partnership with MICRO-TECH Endoscopy, which is responsible for distributing our products in the U.K. and Ireland, as well as other international distributors in Europe who are eager to access our new devices."

The CE mark is essential for the free marketability of medical devices across the European Economic Area. Lumendi previously secured and maintained CE certification for the DiLumen EZ Glide since July 2018 and has now expanded this certification under EU Medical Device Regulation 2017/745 to include the complete DiLumen product line. Furthermore, the company has upheld the certification of its Quality Management System in accordance with ISO 13485:2016 since July 2017.

So far, more than 6,000 procedures have been conducted globally using the DiLumen Endoscopic Interventional Platform. Clinical studies, abstracts, and various case reports have highlighted the platform's advantages regarding safety, effectiveness, and cost-efficiency. The DiLumen EZ1 and C1 are non-sterile, single-use sleeves that are designed to fit over standard endoscopes, offering better stabilization within the large intestine, which ultimately enhances access, visualization, diagnosis, and precision treatment.

Headquartered in Zug, Switzerland, Lumendi AG dedicates itself to improving patient outcomes and lowering healthcare expenses through the innovative development of endoscopic equipment. Lumendi LLC, its wholly-owned subsidiary in Westport, CT, works diligently towards these goals. For further details and updates, you can visit the official websites at lumendi.com and lumendilearning.com.

Conclusion

The receipt of CE certification for Lumendi's DiLumen devices not only exemplifies the company's dedication to improving healthcare practices but also showcases the potential of advanced endoluminal technologies in revolutionizing procedures previously thought complex. As these devices enter the European market, Lumendi aims to bolster partnerships and expand their footprint in the medical device sector, paving the way for innovations that ultimately benefit both practitioners and patients alike.