Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Lumendi Receives FDA Clearance to Market DiLumen™ for Endolumenal Therapy

December 13, 2016 By Business Wire

Connecticut-based medical device innovator Lumendi, LLC http://www.lumendi.com has announced it has received United States Food and Drug Administration (FDA) 510(k) clearance for the DiLumen™, an endoscopic accessory that is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment.

DiLumen is a pioneering technology that stabilizes a colonoscope to better facilitate incision-free endolumenal therapeutic procedures, which are complex procedures utilizing a flexible colonoscope and therapeutic devices inserted into the colon to locate and treat diseased tissue while preserving the colon. The device was developed by Lumendi in collaboration with the Minimally Invasive New Technologies program (MINT) at Weill Cornell Medicine and New York-Presbyterian http://www.mint.weill.cornell.edu It is the first device from the Endolumenal Interventional Platform based on Lumendi and MINT’s initiative to migrate many gastrointestinal surgeries to endolumenal procedures.

DiLumen™ (Credit: Business Wire)

According to Dr. Peter Johann, CEO of Lumendi, Ltd., “DiLumen is the first step in a family of devices to enhance endoscopic treatment, including many promising endolumenal therapeutic procedures, that may ultimately improve patient care. Lumendi sees a great potential in endolumenal interventions and is committed to build on this opportunity.”

DiLumen facilitates endoscopic treatment of colonic lesions such as polyps, a common condition that affects millions worldwide. Such treatments may take the place of open surgical or laparoscopic procedures, potentially reducing healthcare costs.

DiLumen consists of a single-use, soft flexible sheath that fits over standard and small-diameter colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated, a stable Therapeutic Zone (TZ) is created. This TZ facilitates more localized insufflation and manipulation of the colon and provides improved access to lesions to enable endoscopists and surgeons to perform precise endolumenal interventions. Once the procedure is complete, the balloons are deflated and removed along with the colonoscope.

“DiLumen’s use during flexible colonoscopy is an important technical advance in a field that has previously been defined by laparoscopic and open surgical procedures. DiLumen can stabilize a section of colon and facilitate the endoscopic removal of complex adenomas or polyps, with the potential to positively impact patient outcomes. Although reporting of results in patients awaits clinical studies, we are extremely optimistic that this technology will be transformative in treating digestive diseases,” said Jeffrey Milsom, M.D., Chief of Colorectal Surgery at New York-Presbyterian/Weill Cornell Medical Center and Co-Director of the MINT Program, and the Jerome J. Decosse, MD, Distinguished Professor of Surgery at Weill Cornell Medicine. Dr. Milsom is a co-inventor of DiLumen and a paid member of a clinical advisory board for Lumendi, Ltd.

Related Articles Read More >

Logos of Creo Medical and Intuitive
Creo Medical inks collaboration agreement with Intuitive
Lazurite ArthroFree wireless surgical camera system Minnetronix Medical
How Minnetronix Medical helped Lazurite with its wireless surgical camera
Medtronic Hugo robot-assisted surgery system
The road to a robot: Medtronic’s development process for its Hugo RAS system
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age

DeviceTalks Weekly.

May 27, 2022
Quick message - No DTW podcast, but plenty else to listen to over this weekend and next week.
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech