Medical devices maker Lumendi has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its DiLumen Is endolumenal interventional scissors.
DiLumen Is is a sterile, single-use, disposable and monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.
DiLumen Is is the firm’s fourth device, and along with recently 510(k) cleared DiLumen C2 will round out a complete platform of accessories specified to improve access and therapy in the colon and reduce surgical interventions.
The second-generation endolumenal interventional platform (EIP) has been developed to offer complete positioning of an endoscope in the large intestine and help in the optical visualization, diagnosis and endoscopic treatment.
DiLumen EIP is provided with a single-use and soft flexible sheath, which fits over standard and small-diameter endoscopes.
The device includes two balloons, one behind the bending section of the endoscope and the second that can expand in front of the tip of the endoscope once at the lesion site.
A stable therapeutic zone (TZ) will be formed, when both balloons are deployed and inflated.
Lumendi CEO Dr Peter Johann said: “The DiLumen platform of devices, now complemented by DiLumen Is, is designed to further facilitate and improve technically difficult and time-consuming endoscopic interventions for colonic lesions, such as polyps, a common condition that affects millions worldwide, and may replace invasive open surgical or laparoscopic procedures for patient benefit and potentially reducing healthcare costs.”
Lumendi’s other DiLumen accessories include Ig endolumenal interventional grasper and Im endolumenal intervention mount.
The Ig endolumenal interventional grasper is a flexible endoscopic tool developed to grasp and manipulate tissue within the digestive tract under direct endoscopic visualization.
The Im endolumenal intervention mount is an ergonomically designed workstation, which will support the various accessories and enable the clinician to carry out procedures in a comfortable standing or seated position.