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Lumendi Requests 510(k) Clearance for Two New Products | News

WESTPORT, Conn.–(BUSINESS WIRE)–May 19, 2022–

Connecticut-based medical device innovator Lumendi, LLC (http://www.lumendi.com) announced that it has filed for 510(k) clearance with the Food and Drug Administration (FDA). ) of the United States for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMRs) and difficult colonoscopies. The new design, based on the long-standing success of the DiLumen EZ-Glide platform, has been modified and streamlined. “This new device will serve to enrich our product portfolio and bring further improvements to complex polyp resections through the procedure known as endoscopic mucosal resections (EMRs). EMR accounts for the majority share of polyp resection procedures worldwide, with over one million cases per year,” said Dr. Peter Johann, CEO of Lumendi, Ltd.

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DiLumen EZ¹ single balloon stabilizing endotherapy device. (Photo: BusinessWire)

Simultaneously, Lumendi has filed for 510(k) clearance with the US Food and Drug Administration for a second device, named DiLumen C¹, which is designed to facilitate the complex resection of polyps in the colon. C¹’s design offers a single working channel that accommodates an atraumatic forceps, allowing for more direct tissue manipulation and traction. C¹ and Grasper will improve in block dissection of precancerous, non-invasive cancerous polyps, a procedure known as endoscopic submucosal dissection (ESD). After many years of feedback from leading clinicians, Lumendi believes that inadequate tissue manipulation and traction, combined with ineffective cutting, dissection and cauterization, continues to be a major challenge for many therapeutic procedures. in the digestive tract. These are the ninth and tenth devices developed by Lumendi, as the company continues to advance minimally invasive endoluminal therapies.

Lumendi is also pleased to announce that to date, clinicians in the United States, in several EU countries, including Germany, France, Italy, Spain and the United Kingdom, as well as the Chinese University of Hong Kong, have performed over 3,000 procedures with the commercially available DiLumen EZ Glide.

“These new products, along with the strong market adoption of DiLumen EZ Glide, will help accelerate Lumendi’s continued vision to migrate many invasive gastrointestinal surgeries that require hospital stays, increased risk of infection high and longer recoveries to much less invasive endoluminal procedures with low complication rates, no hospital stays and very minimal recovery times. says Dr. Johann. “Additionally, based on our success in impacting therapeutic procedures in the colon and using our current technology, we recently initiated an upper gastrointestinal intervention development program that we believe will lead to less invasive and less expensive procedures with equal or better results.

The DiLumen EZ¹ and C¹ are part of a growing platform of accessories that work in conjunction with endoscopes and gastroscopes used in the large intestine that facilitate access to navigation, optical visualization, diagnosis and treatment endotherapeutic.

About Lumendi, LLC (Lumendi) Based in Westport, Connecticut, Lumendi, LLC is a wholly owned subsidiary of Lumendi Ltd., a privately held, innovative medical device company based in Maidenhead, UK. Lumendi is focused on the development, marketing and distribution of surgical tools and devices that provide safe and cost-effective solutions for minimally invasive gastrointestinal procedures.

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CONTACT: Donna K. Ramer

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KEYWORD: CONNECTICUT UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: FDA MEDICAL DEVICES HOSPITALS HEALTH SURGERY

SOURCE: Lumendi, LLC

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PUBLISHED: 05/19/2022 08:00/DISC: 05/19/2022 08:02

http://www.businesswire.com/news/home/20220519005402/en

Copyright BusinessWire 2022.