Author: Antonio Caycedo-Marulanda
Lumendi received FDA approval for new DiLumen Ik™ endolumenal interventional knife in August of 2019.
Lumendi is a Connecticut-based medical device innovator company that designed a single-use disposable monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. It is also designed to deliver a seamless submucosal injection to create and maintain a fluid cushion during tissue dissection. This new device can be manipulated to cut and dissected in a way that may improve removal of lesions during endolumenal interventions.
The single-use monopolar device is used for surgical dissections, performing cuts, and cauterizing of tissues of the gastrointestinal tract. To help perform many procedures that require a section to be elevated from the surrounding tissue, the same device can be used to administer submucosal fluid injections.
The DiLumen Ik knife is part of a growing platform of accessories that work in conjunction with the second-generation DiLumen C²™ Endolumenal Interventional Platform (EIP), which is designed to provide complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment. The DiLumen EIP consists of a 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 the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to more effectively treat the target area. Once the therapy is completed, the balloons are simply deflated and removed along with the colonoscope.
Lumendi reports 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 1,000 procedures with the commercially available DiLumen™ EIP. Three clinical studies using the DiLumen EIP have also been completed — further demonstrating safety and cost effectiveness — and are pending publication.
The device is designed to enhance the safety of endoscopic submucosal dissection. The device may not be used when colonoscopy is contraindicated.
Endolumenal interventional knife
Dynamic Retraction System
Endoscopic Submucosal Dissection Specimen