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Lumendi Files for FDA 510(k) Clearance for Two New Products
May 24, 2022
Lumendi, LLC has announced it has filed for U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device intended for endoscopic mucosal resections (EMR) 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 enhance our product portfolio and bring further improvements to complex polyp resections through the procedure known as Endoscopic Mucosal Resections (EMR). EMR represents the majority share of polyp resection procedures worldwide, with over 1 million cases annually,” said Dr. Peter Johann, CEO, Lumendi, Ltd.
Simultaneously, Lumendi has filed for U.S. Food and Drug Administration 510(k) clearance of a second device, named DiLumen C¹, which is designed to facilitate complex polyp resection in the colon. C¹’s design offers a single working channel that accommodates an atraumatic grasper, which provides more direct tissue manipulation and traction. The C¹ and Grasper will improve enbloc dissection of precancerous and non-invasive cancerous polyps, a procedure known as Endoscopic Submucosal Dissection (ESD). Following several years of feedback from leading clinicians, Lumendi believes that inadequate tissue manipulation and traction, combined with ineffective cutting, dissecting, and cauterizing, continues to be a major challenge for many therapeutic procedures in the digestive tract. These are the ninth and tenth devices Lumendi has developed, as the company continues to advance minimally invasive endolumenal therapies.
Lumendi is pleased to also report that, to date, clinicians in the U.S., several EU countries including Germany, France, Italy, Spain, and the U.K., as well as at the Chinese University of Hong Kong, have completed over 3,000 procedures with the commercially available DiLumenEZ 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, higher risks of infection and longer recoveries to much less invasive endoluminal procedures with low complication rates, no hospital stays and very minimal recovery times.” said Dr. Johann. “In addition, based on our success impacting therapeutic procedures in the colon and using our current technology, we have recently started a development program in upper GI interventions that we expect will lead to less invasive and less costly procedures with equal or better outcomes.”
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 assist with navigational access, optical visualization, diagnosis and endotherapeutic treatment.
About Lumendi, LLC (Lumendi) Headquartered 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 focuses on developing, marketing, and distributing surgical tools and devices that provide safe, cost-effective solutions for minimally invasive gastrointestinal interventions.
See Full Press Release at the Source: Lumendi Files for 510(k) Clearance for Two New Products
Press Release by: Lumendi, LLC
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