Sam Brusco, Associate Editor02.17.23
Lumendi has achieved 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. The company also earned FDA clearance for its DiLumen C1 to facilitate complex polyp resection in the colon and rectum via endoscopic submucosal dissection (ESD).
“The DiLumen EZ device will meaningfully enhance our product portfolio by meeting more procedure specific needs for complex polyp resections which are conducted through EMR. Globally, EMR procedures represent the majority share of the over one million polyp resections conducted, annually,” Dr. Peter Johann, CEO of Lumendi told the press.
C1’s design has a single working channel to accommodate an atraumatic grasper, providing more direct tissue manipulation and traction. Using the C1 and grasper helps improve curative removal of precancerous and non-invasive cancerous polyps during ESD.
With DiLumen, DiLumen EZ1, and DiLumen C, Lumendi now offers a complete set of devices to perform any kind of complex polypectomy and potential other interventions in the entire colon.
”Since 2017, clinicians in the U.S., EU, the UK and Asia, have completed over 4,000 procedures with the commercially available DiLumen EZ Glide. These newest devices, when combined with the increasing market adoption of DiLumen EZ Glide, will accelerate Lumendi’s continued vision to shift procedures away from invasive gastrointestinal surgeries, towards endoluminal procedures with lower complication rates, little to 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 will look to expand our development program into upper GI interventions, which we expect will lead to better patient 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, which assist with navigational access, optical visualization, diagnosis and endotherapeutic treatment.
“The DiLumen EZ device will meaningfully enhance our product portfolio by meeting more procedure specific needs for complex polyp resections which are conducted through EMR. Globally, EMR procedures represent the majority share of the over one million polyp resections conducted, annually,” Dr. Peter Johann, CEO of Lumendi told the press.
C1’s design has a single working channel to accommodate an atraumatic grasper, providing more direct tissue manipulation and traction. Using the C1 and grasper helps improve curative removal of precancerous and non-invasive cancerous polyps during ESD.
With DiLumen, DiLumen EZ1, and DiLumen C, Lumendi now offers a complete set of devices to perform any kind of complex polypectomy and potential other interventions in the entire colon.
”Since 2017, clinicians in the U.S., EU, the UK and Asia, have completed over 4,000 procedures with the commercially available DiLumen EZ Glide. These newest devices, when combined with the increasing market adoption of DiLumen EZ Glide, will accelerate Lumendi’s continued vision to shift procedures away from invasive gastrointestinal surgeries, towards endoluminal procedures with lower complication rates, little to 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 will look to expand our development program into upper GI interventions, which we expect will lead to better patient 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, which assist with navigational access, optical visualization, diagnosis and endotherapeutic treatment.