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.–(BUSINESS WIRE)–Connecticut-based medical device innovator Lumendi, LLC (http://www.lumendi.com)
has launched its DiLumen +DR Dynamic Retraction System, unveiling it at
the 2019 Digestive Disease Week (DDW) in San Diego and this month’s
American Society of Colon and Rectal Surgeons (ASCRS) in Cleveland.

The DiLumen +DR is a new feature of the fore balloon assembly to help
facilitate tissue manipulation for easier dissection and resection of
polyps without the need for surgical intervention. The DiLumen +DR
consistently provides effective tissue retraction, continuous tissue
tension, and superior visualization of submucosal tissue planes enabling
precise dissection. In addition to being used to create traction in ESD,
the +DR System can be attached to a large pedunculated polyp via a
detachable snare to ‘pull’ the polyp aside and expose the stalk.

According to Dr. Peter Johann, CEO of Lumendi, Ltd., “This modification
to DiLumen has the potential to revolutionize tissue manipulation during
both ESD and EMR. Current methods of retraction for ESD are clunky at
best. Some involve anchoring a spring to a clip or using floss and a
clip to create counter traction along the oral side of the polyp. Unlike
the DiLumen +DR, these other procedures involve significant skills to
master, and provide limited capabilities.”

Lack of proper traction and tissue manipulation has long plagued
advanced endoscopists and colorectal surgeons. The DiLumen +DR has
suture loops attached to the DiLumen’s fore balloon assembly. An
endoscopic clip can then be simultaneously attached to the suture and
the mucosal edge of a polyp during resection. Because the DiLumen fore
balloon can be moved back and forth, doctors can now provide continuous
and controlled traction to the tissue, which will enhance their ability
to lift and dissect and ultimately resect polyps.

“The new logo quickly and easily conveys how DiLumen +DR revolutionizes
polyp resection,” said Eric Coolidge, Vice President, Marketing, Lumendi
LLC. “The visual of the bridge is an architectural depiction of dynamic
retraction in action and was designed by world-renown architect Santiago
Calatrava to demonstrate lift and traction in a similar manner as
DiLumen +DR would work in a lumen.”

The DiLumen + DR is part of the DiLumen Endolumenal Interventional
Platform (EIP) (https://www.youtube.com/watch?v=Af-Ik0qsgKU),
a non-sterile, single-use, close fitting sleeve that fits securely over
a standard endoscope to stabilize it in the large intestine and
facilitates use of the endoscope for optimal visualization, diagnosis,
tissue manipulation and treatment. It is the first device from the
Endolumenal Interventional Platform based on Lumendi initiative to
migrate many gastrointestinal surgeries to endolumenal procedures.

Lumendi reports that more than 900 therapeutic procedures by more than
50 endoscopists and colorectal surgeons have been completed with its
DiLumen™ EIP technology, continuing to demonstrate the safety, high
performance and therapeutic benefits of the DiLumen. These procedures
are in addition to those in its first-in-human study completed in
October 2017. The DiLumen™ EIP, which received FDA 510(k) clearance to
market in December 2016, has been commercially available in the United
States since May 2017 and in Europe since July 2018, when it received CE
Mark.

With recent regulatory approvals in Europe, Lumendi has conducted
successful procedures with clinicians in many EU countries including
Germany, France, Italy, Spain and the U.K. Lumendi has added
distribution in those countries and continues to expand in others. The
first procedures with DiLumen in Asia were successfully performed
recently at Chinese University of Hong Kong.

About Lumendi, LLC http://www.lumendi.com
Headquartered in Westport, Connecticut, Lumendi, LLC is a wholly owned
subsidiary of Lumendi, Ltd., a privately held innovative, medical device
company headquartered in Buckinghamshire, UK. Lumendi is focused on
developing, marketing and distributing surgical tools and devices that
provide safe, cost-effective solutions for minimally invasive
gastrointestinal interventions. Lumendi Ltd. holds a worldwide exclusive
license from Cornell University on the DiLumen™ technology.

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Contacts

Media Contact: Deanne Eagle
[email protected]
+1.917.387.5866

Lumendi/DiLumen
Contact: Donna K. Ramer

[email protected]
+1.917.744.2669

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