The latest news about Lumendi

EZ¹ successfully completes Customer Evaluation phase.

Lumendi Achieves Key Milestone with Completion of DiLumen EZ¹ Customer Evaluations, Setting the Stage for the Next Phase of DiLumen Product Innovation WESTPORT, CT – July 27, 2023 Lumendi, a… Continue reading EZ¹ successfully completes Customer Evaluation phase.

A Randomized Prospective Study Evaluating Effectiveness Of A Double Balloon Endolumenal Platform For Colorectal EndoscopicSubmucosal Dissection

Endoscopic removal of colonic polyps and early cancers eliminates the need for surgical resection and possible temporary or permanent colostomy.

Dr. Roberta Maselli, receives innovation of the year award for the best new device from the ESGE

Award for the Balloon Endo-Luminal Lumen Occluding (BELLO) Device Presented to Dr. Maselli at the ESGE Days 2023 Congress Apr 20, 2023, 12:27 ET Lumendi Congratulates Dr. Maselli on the… Continue reading Dr. Roberta Maselli, receives innovation of the year award for the best new device from the ESGE

Lumendi Receives 510(k) Clearance for Two New Devices

Lumendi, LLC has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies.

Expansion of the Dilumen Platform

DiLumen EZ¹ The DiLumen EZ¹ is a variant of the DiLumen design, specially intended for the removal of complex polyps using the EMR* technique. Thanks to its unique balloon design,… Continue reading Expansion of the Dilumen Platform

Lumendi Files for 510(k) Clearance for Two New Products

Company Achieves New Milestone with 3,000 Therapeutic Procedures Completed Across U.S., Europe, and Asia Using DiLumen™ EIP DiLumen EZ¹ single balloon stabilization endotherapy device. (Photo: Business Wire) May 19, 2022… Continue reading Lumendi Files for 510(k) Clearance for Two New Products

A successful Digestive Disease Week (DDW) conference in San Diego

Since the company’s inception, we have accumulated over 100 DiLumen users worldwide. Half of these physicians have begun using our devices in the last 12 to 18 months. This year’s DDW was our first opportunity in three years to present Lumendi and our significantly enhanced DiLumen platform to users and industry.

DiLumen EIP is now even easier to use with EZ-Glide hydrophilic coating

DiLumen EZ-Glide improves visibility and simplifies intraoperative

Lumendi Reports Successful Completion Of Dilumen™ Eip First-in-human Trials

LUMENDI REPORTS SUCCESSFUL COMPLETION OF DILUMEN™ EIP FIRST-IN-HUMAN TRIALS   Primary Study Endpoint Reached with no Serious Adverse Events WESTPORT, CONNECTICUT, November 16, 2017 – Connecticut-based medical device innovator Lumendi,… Continue reading Lumendi Reports Successful Completion Of Dilumen™ Eip First-in-human Trials

Thank you to Prof. Peter Bauerfeind and Dr. Hugo Uchima

Thank you to Prof. Peter Bauerfeind and Dr. Hugo Uchima for a great workshop in Lucerne. The international group of endoscopists enjoyed the educational value and the practical experience of… Continue reading Thank you to Prof. Peter Bauerfeind and Dr. Hugo Uchima

Thank you for supporting our Patient Awareness Initiative

Thank you for supporting our Patient Awareness Initiative

Lumendi Announces CMS HCPCS Code for Reimbursement of ESD Procedures Performed in Hospital Outpatient Facilities

October 19, 2021 08:00 AM Eastern Daylight Time   WESTPORT, Conn.--(BUSINESS WIRE)--Lumendi-- Effective October 1, 2021, the Centers for Medicare & Medicaid Services (CMS) established C9779 as a new Healthcare… Continue reading Lumendi Announces CMS HCPCS Code for Reimbursement of ESD Procedures Performed in Hospital Outpatient Facilities

EZ Glide Pushes Lumendi to New Quarter-Over-Quarter Sales Record

DiLumen® Product Enhancement Launched in December 2020 on Track to Double Sales from Previous Year September 28, 2021 WESTPORT, Conn.--(BUSINESS WIRE)-- EZ Glide, the most recent enhancement to Lumendi’s DiLumen Endoluminal Interventional… Continue reading EZ Glide Pushes Lumendi to New Quarter-Over-Quarter Sales Record

Invitation Skills Lab, Switzerland

INTRODUCING LUMENDI'S LATEST INNOVATION At Lumendi, we’re committed to creating technologies that enable physicians to perform at a higher level, minimize risk and recovery time for patients. We invite you… Continue reading Invitation Skills Lab, Switzerland

Introducing Lumendi’s latest Innovation in Asia

Innovative Surgical Platform Improves the Safety and Speed of Endolumenal Procedures For patients with complex benign colorectal polyps, surgical intervention tends to be the norm. Yet, endoluminal procedures like endoscopic… Continue reading Introducing Lumendi’s latest Innovation in Asia

Introducing EZ Glide in Europe

Many studies have documented that an endoscopic approach for ESD is a safer and less expensive alternative to removing these polyps, leading to fewer postoperative complications and shorter hospital stays.

Lumendi Introduces EZ Glide Hydrophilic Coating for Its DiLumen Endoluminal Interventional Platform (EIP™)

Lumendi Platforms to be Discussed in Investor’s Webcast 31 March 2021 with Panel of Clinical Experts New EZ Glide, activated by water or saline, improves endoscopic performance of the DiLumen… Continue reading Lumendi Introduces EZ Glide Hydrophilic Coating for Its DiLumen Endoluminal Interventional Platform (EIP™)

DiLumen online

Online Support for Clinical Cases With the current restrictions travel and in-house visits are often limited or impossible. The Lumendi team will continue to support you with the use of… Continue reading DiLumen online

ASGE Webinar Online

Upcoming ASGE Webinar: Navigating the Tortuous Colon Reimbursement for Complex Endoscopic Resection January 14th at 8pm EST (7pm CST) Join ASGE staff and Dr. Othman as they cover the following:… Continue reading ASGE Webinar Online

PIONEERING ENDOSURGERY NEW MISSION STATEMENT AT LUMENDI

Pioneering Endosurgery reflects Lumendi’s innovative, three-part pathway to:

expand indication areas and procedures in the upper gastrointestinal tract, which includes a recent submission to the FDA;
innovate improvements planned for the DiLumen EIP, including a proprietary lubricated inner surface of DiLumen’s sheath for better endoscope handling performance; and
commercially release the DiLumen C2 platform[1] to bring robotic-like end-effectors to endolumenal surgery in a low-cost, disposable format to provide endoscopists with unprecedented control of tissue.

LUMENDI REPORTS FIRST INCISIONLESS APPENDECTOMY USING DOUBLE-BALLOON ENDOLUMENAL INTERVENTIONAL PLATFORM

Dr. Kantsevoy states, “Endoscopic endolumenal appendectomy is less invasive than traditional surgical, laparoscopic, transvaginal or transgastric appendectomy.

Early Trial Data Show Promise in Endoscopic Procedure Time Study

A study evaluating endoscopic procedure time removing complex colorectal polyps shows superiority of Lumendi’s DiLumen device over a control group.

LUMENDI OPERATIONS AND CLINICAL SUPPORT REMAIN AVAILABLE DURING OBSERVANCE OF COVID-19 PRECAUTIONS.

We have adapted our operation and clinical support models as healthcare facilities prioritize focus on patients affected by COVID-19.

LUMENDI REPORTS SUCCESSFUL ENROLLMENT CLOSURE OF ITS DILUMEN™ ENDOLUMENAL INTERVENTIONAL PLATFORM (EIP™) STUDY

The study evaluates DiLumen’s effect on endoscopic procedure time for pre-cancerous colorectal complex polypectomies.

LARGE COMPLEX POLYPS REMOVED SUCCESSFULLY FROM THREE PATIENTS WITHOUT SURGICAL INTERVENTION USING LUMENDI DILUMEN C2™

The first successful case at Cleveland Clinic using DiLumen C2 was completed by Dr. Gorgun when a large complex polyp in the distal sigmoid, 18cm from the anus was removed from a 72-year-old woman with a narrow sigmoid.

LUMENDI RECEIVES 510(k) CLEARANCE FOR DILUMEN Ik™ ENDOLUMENAL INTERVENTIONAL KNIFE

1000 Therapeutic Procedures Using DiLumen™ EIP Completed Across U.S., Europe and Asia WESTPORT, CONN, August 20, 2019 − Connecticut-based medical device innovator Lumendi, LLC (http://www.lumendi.com) has announced it has received U.S.… Continue reading LUMENDI RECEIVES 510(k) CLEARANCE FOR DILUMEN Ik™ ENDOLUMENAL INTERVENTIONAL KNIFE

LUMENDI BRANDS EXCLUSIVE TISSUE MANIPULATION FEATURE FOR COMPANY’S DILUMEN EIP

DiLumen +DR Dynamic Retraction System Improves Endoscopists’ Ability to Dissect and Ultimately Resect Polyps Without Surgical Intervention WESTPORT, CONN, June 11, 2019 — Connecticut-based medical device innovator Lumendi, LLC has launched… Continue reading LUMENDI BRANDS EXCLUSIVE TISSUE MANIPULATION FEATURE FOR COMPANY’S DILUMEN EIP

LUMENDI RECEIVES FDA 510(k) CLEARANCE FOR DILUMEN C2TM

Second Generation Endoscopic Accessory for Endolumenal Procedures WESTPORT, CONN, April 23, 2018 – Connecticut-based medical device innovator Lumendi, LLC has announced it has received United States Food and Drug Administration… Continue reading LUMENDI RECEIVES FDA 510(k) CLEARANCE FOR DILUMEN C2TM

MEDICAL MARVELS with Eyewitness News

MEDICAL MARVELS   Dual balloon endoscope device reduces the need for surgery to remove polyps.   As seen on Eyewitness News | Tuesday, January 29, 2019 12:00AM UPPER EAST SIDE, Manhattan… Continue reading MEDICAL MARVELS with Eyewitness News

LUMENDI RECEIVES FDA 510(k) CLEARANCE FOR INNOVATIVE DILUMEN EIP DEVICE MODIFICATION TO IMPROVE TISSUE RETRACTION DURING THERAPEUTIC ENDOSCOPY

With recent regulatory approvals in Europe, Lumendi has established distribution in the UK, France and Italy and has conducted successful procedures with clinicians in each country.

500 THERAPEUTIC PROCEDURES USING DILUMEN EIP COMPLETED ACROSS U.S., EUROPE AND ASIA

WESTPORT, CONN, OCTOBER 4, 2018 − Connecticut-based medical device innovator Lumendi, LLC reports that more than 500 therapeutic procedures by more than 40 endoscopists and colorectal surgeons have been completed… Continue reading 500 THERAPEUTIC PROCEDURES USING DILUMEN EIP COMPLETED ACROSS U.S., EUROPE AND ASIA

LUMENDI EXPANDS TEAM WITH NEW VP OF SALES, MICHAEL R. THOMAS

WESTPORT, CT, August 21, 2018 – Connecticut-based medical device innovator Lumendi, LLC is again expanding its team as Michael R. Thomas joins as Vice President of Sales. Mr. Thomas is… Continue reading LUMENDI EXPANDS TEAM WITH NEW VP OF SALES, MICHAEL R. THOMAS

LUMENDI OPENS EU MARKET FOR DILUMEN EIP

CE Certification Confirms Device Conforms to Medical Device Directive 93/42/EEC BUCKINGHAMSHIRE, UK,  JULY 17, 2018 -- Lumendi Ltd., a privately held innovative medical device company, today announced that its subsidiary,… Continue reading LUMENDI OPENS EU MARKET FOR DILUMEN EIP

FLEXIBLE ENDOSCOPIC DOUBLE BALLOON PLATFORM: FROM CONCEPT TO HUMAN FEASIBILITY TRIAL

Flexible Endoscopic Double Balloon Platform: from concept to human feasibility trial. Sam Sharma*, Kota Momose, Toyooki Sonoda, Reem Z. Sharaiha Weill Cornell Medical College, New York, NY Background: Despite the… Continue reading FLEXIBLE ENDOSCOPIC DOUBLE BALLOON PLATFORM: FROM CONCEPT TO HUMAN FEASIBILITY TRIAL

LUMENDI RECEIVES FDA 510(k) CLEARANCE FOR DILUMEN Is ENDOLUMENAL INTERVENTIONAL SCISSORS

Second Generation Endoscopic Accessory for Endolumenal Procedures WESTPORT, CONN, May 29, 2018 − Connecticut-based medical device innovator Lumendi, LLC has announced it has received United States Food and Drug Administration… Continue reading LUMENDI RECEIVES FDA 510(k) CLEARANCE FOR DILUMEN Is ENDOLUMENAL INTERVENTIONAL SCISSORS

LUMENDI RECEIVES FDA 510(k) CLEARANCE FOR DILUMEN C2TM

Second Generation Endoscopic Accessory for Endolumenal Procedures WESTPORT, CONN, April 23, 2018 – Connecticut-based medical device innovator Lumendi, LLC has announced it has received United States Food and Drug Administration… Continue reading LUMENDI RECEIVES FDA 510(k) CLEARANCE FOR DILUMEN C2TM

Lumendi to Present at Digital Medicine & Medtech Showcase

  Lumendi to Present at Digital Medicine & Medtech Showcase WESTPORT, CONN, November 10, 2017 – Lumendi Ltd., a privately held innovative medical device company, announced today that Chief Executive Officer… Continue reading Lumendi to Present at Digital Medicine & Medtech Showcase

Stabilizing The Scope: How The DiLumen EIP Changes Intestinal Surgery

Stabilizing The Scope: How The DiLumen EIP Changes Intestinal Surgery Daniel Seeger Editor with www.surgicalproductsmag.com Surgeons interested in expanding their alternatives in pursuing minimally invasive options need to be attuned to… Continue reading Stabilizing The Scope: How The DiLumen EIP Changes Intestinal Surgery

DILUMEN™ EIP COMPLETES 100 THERAPEUTIC PROCEDURES ACROSS UNITED STATES

DILUMEN™ EIP COMPLETES 100 THERAPEUTIC PROCEDURES ACROSS UNITED STATES WESTPORT, CONN, DECEMBER 6, 2017 − Connecticut-based medical device innovator Lumendi, LLC reports it has successfully completed more than 100 therapeutic procedures… Continue reading DILUMEN™ EIP COMPLETES 100 THERAPEUTIC PROCEDURES ACROSS UNITED STATES

LUMENDI REPORTS SUCCESSFUL COMPLETION OF DILUMEN™ EIP FIRST-IN-HUMAN TRIALS

LUMENDI REPORTS SUCCESSFUL COMPLETION OF DILUMEN™ EIP FIRST-IN-HUMAN TRIALS Primary Study Endpoint Reached with no Serious Adverse Events WESTPORT, CONNECTICUT, November 16, 2017 – Connecticut-based medical device innovator Lumendi, LLC… Continue reading LUMENDI REPORTS SUCCESSFUL COMPLETION OF DILUMEN™ EIP FIRST-IN-HUMAN TRIALS

LUMENDI’S DILUMEN Ig™ ENDOLUMENAL INTERVENTIONAL GRASPER FOR MINIMALLY INVASIVE ENDOSCOPIC THERAPIES NOW AVAILABLE IN U.S.

LUMENDI’S DILUMEN Ig™ ENDOLUMENAL INTERVENTIONAL GRASPER FOR MINIMALLY INVASIVE ENDOSCOPIC THERAPIES NOW AVAILABLE IN U.S. Lumendi Submits Premarket Notification to US FDA For DiLumen C2™ and the DiLumen Is™ as Part… Continue reading LUMENDI’S DILUMEN Ig™ ENDOLUMENAL INTERVENTIONAL GRASPER FOR MINIMALLY INVASIVE ENDOSCOPIC THERAPIES NOW AVAILABLE IN U.S.

LUMENDI EXPANDS MEDICAL ADVISORY BOARD WITH THREE GLOBAL EXPERTS IN ADVANCED ENDOSCOPY

LUMENDI EXPANDS MEDICAL ADVISORY BOARD WITH THREE GLOBAL EXPERTS IN ADVANCED ENDOSCOPY Dr. Sergey V. Kantsevoy, Professor Alessandro Repici and Professor Kazuki Sumiyama to help guide improvements in endoscopic interventions… Continue reading LUMENDI EXPANDS MEDICAL ADVISORY BOARD WITH THREE GLOBAL EXPERTS IN ADVANCED ENDOSCOPY

LUMENDI EXPANDS SOCIAL MEDIA PRESENCE

LUMENDI EXPANDS SOCIAL MEDIA PRESENCE WITH NEW YOU TUBE CHANNEL DEDICATED TO ITS DILUMEN™ EIP WESTPORT, CONNECTICUT, October 4, 2017 – Lumendi, LLC (http:/lumendi.com), a wholly owned subsidiary of Lumendi,… Continue reading LUMENDI EXPANDS SOCIAL MEDIA PRESENCE

LUMENDI ACHIEVES ISO 13485 CERTIFICATION FOR ITS MEDICAL DEVICES

LUMENDI ACHIEVES ISO 13485 CERTIFICATION FOR ITS MEDICAL DEVICES WESTPORT, CONNECTICUT, August 1, 2017 – Connecticut-based Lumendi, LLC (www.lumendi.com) recently received ISO 13485 certification from BSI, a worldwide recognized leader… Continue reading LUMENDI ACHIEVES ISO 13485 CERTIFICATION FOR ITS MEDICAL DEVICES

LUMENDI DILUMEN™ EIP NOW AVAILABLE FOR ENDOLUMENAL THERAPY

LUMENDI DILUMENTM EIP NOW AVAILABLE FOR ENDOLUMENAL THERAPY New Technical Advance in Endolumenal Interventional Platform Expected to Improve Patient Care CHIGAGO, ILLINOIS, May 7, 2017 – Connecticut-based medical device innovator… Continue reading LUMENDI DILUMEN™ EIP NOW AVAILABLE FOR ENDOLUMENAL THERAPY

MEDIA ALERT: PHOTO & VIDEO OPPORTUNITIES
DILUMEN™ ENDOLUMENAL INTERVENTION PLATFORM DEMONSTRATED IN WET AND DRY LABS AT DDW BOOTH #1808

MEDIA ALERT: PHOTO & VIDEO OPPORTUNITIES DILUMEN™ ENDOLUMENAL INTERVENTION PLATFORM DEMONSTRATED IN WET AND DRY LABS AT DDW BOOTH #1808 Lumendi LLC will be demonstrating their new DiLumen™ Endolumenal Intervention… Continue reading MEDIA ALERT: PHOTO & VIDEO OPPORTUNITIES
DILUMEN™ ENDOLUMENAL INTERVENTION PLATFORM DEMONSTRATED IN WET AND DRY LABS AT DDW BOOTH #1808

LUMENDI EXPANDS TEAM WITH LAURENCE LEFEBVRE

LUMENDI EXPANDS TEAM WITH LAURENCE LEFEBVRE AS SENIOR DIRECTOR PROGRAM MANAGEMENT WESTPORT, CT, May 1, 2017 -- Laurence Lefebvre, from New Rochelle, New York, has joined Connecticut-based medical device innovator… Continue reading LUMENDI EXPANDS TEAM WITH LAURENCE LEFEBVRE

LUMENDI EXPANDS WITH FIVE REGIONAL SALES MANAGERS

LUMENDI EXPANDS WITH FIVE REGIONAL SALES MANAGERS WESTPORT, CT, April 4, 2017 -- Connecticut-based medical device innovator Lumendi, LLC has expanded its continually growing employee base with five regional sales… Continue reading LUMENDI EXPANDS WITH FIVE REGIONAL SALES MANAGERS

Lumendi LLC Laurence Lefebvre

Medical Advisory Board and some DiLumen Team Members in Japan - testing our products. Lumendi LLC has hired Laurence Lefebvre to further strengthen the talent already working for Lumendi LLC.… Continue reading Lumendi LLC Laurence Lefebvre

Lumendi adds two executives: 3 things to know

GI & Endoscopy-Driven ASCs Lumendi adds two executives: 3 things to know Written by Eric Oliver | January 17, 2017 Connecticut-based medical device developer Lumendi added James Soares as its vice… Continue reading Lumendi adds two executives: 3 things to know

LUMENDI EXPANDS STAFF WITH TWO NEW HIRES: VP SALES AND SENIOR DIRECTOR OF BUSINESS DEVELOPMENT

LUMENDI EXPANDS STAFF WITH TWO NEW HIRES: VP SALES AND SENIOR DIRECTOR OF BUSINESS DEVELOPMENT Industry Veterans James Soares and Yukio Nakajima Join Lumendi’s Endolumenal Interventional Platform Team WESTPORT, CT,… Continue reading LUMENDI EXPANDS STAFF WITH TWO NEW HIRES: VP SALES AND SENIOR DIRECTOR OF BUSINESS DEVELOPMENT

DiLumen Endolumenal Therapy System for Procedures Inside Large Intestine FDA Cleared

DiLumen Endolumenal Therapy System for Procedures Inside Large Intestine FDA Cleared December 23rd, 2016 Lumendi, LLC, a U.S. subsidiary of Lumendi, Ltd. out of London, England, won FDA clearance for… Continue reading DiLumen Endolumenal Therapy System for Procedures Inside Large Intestine FDA Cleared

FDA Awards Lumendi Marketing Clearance for DiLumen

FDA Awards Lumendi Marketing Clearance for DiLumen Dec. 14, 2016 Lumendi has received FDA marketing clearance for DiLumen, an endoscopic device used in the surgical treatment of colon lesions. DiLumen… Continue reading FDA Awards Lumendi Marketing Clearance for DiLumen

LUMENDI RECEIVES FDA CLEARANCE TO MARKET DILUMEN™ FOR ENDOLUMENAL THERAPY

LUMENDI RECEIVES FDA CLEARANCE TO MARKET DILUMEN™ FOR ENDOLUMENAL THERAPY New Endolumenal Interventional Platform Developed by Lumendi with Digestive Disease Leaders at New York-Presbyterian and Weill Cornell Medicine’s MINT Program… Continue reading LUMENDI RECEIVES FDA CLEARANCE TO MARKET DILUMEN™ FOR ENDOLUMENAL THERAPY

Lumendi’s colonoscope stabilizer picks up FDA nod

Lumendi's colonoscope stabilizer picks up FDA nod by Amirah Al Idrus | Dec 13, 2016 9:48am The DiLumen device stabilizes colonoscopes for endoluminal procedures—treatments for ailments of the colon that… Continue reading Lumendi’s colonoscope stabilizer picks up FDA nod

Weill Cornell Medical College and NewYork-Presbyterian Hospital License Technology to Lumendi, Ltd.

Weill Cornell Medical College and NewYork-Presbyterian Hospital License Technology to Lumendi, Ltd.   Start-Up Company Dedicated to Developing and Commercializing Products Aimed At Revolutionizing Gastrointestinal Surgeries   NEW YORK —… Continue reading Weill Cornell Medical College and NewYork-Presbyterian Hospital License Technology to Lumendi, Ltd.

Weill Cornell Medical College and NewYork-Presbyterian Hospital License Technology to Lumendi, Ltd.

Weill Cornell Medical College and NewYork-Presbyterian Hospital License Technology to Lumendi, Ltd.   Start-Up Company Dedicated to Developing and Commercializing Products Aimed At Revolutionizing Gastrointestinal Surgeries   NEW YORK (September… Continue reading Weill Cornell Medical College and NewYork-Presbyterian Hospital License Technology to Lumendi, Ltd.