Connecticut-based medical device innovator Lumendi, LLC has announced its new endoscopic accessory, DiLumen EIP, is now available for use as-indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment. Because such a device may improve endolumenal treatments, DiLumen EIP may better enable these less-invasive procedures and take the place of open or laparoscopic surgery, thereby preserving anatomy, shortening recovery and reducing healthcare costs.
Lumendi received U.S. FDA 510(k) clearance to market DiLumen in December 2016. A post-market outcome study is now underway to demonstrate the capabilities of DiLumen during endoscopy procedures.
“DiLumen is an important advance in a field defined until now by laparoscopic and open surgical procedures,” says Dr. Peter Johann, CEO of Lumendi, Ltd. “We recently hired a team of five dedicated regional sales managers, each of whom has extensive experience in medical devices and new technology as well as gastroenterology and related diseases. This team will help educate and train advanced endoscopists, colorectal surgeons, and gastroenterologists nationwide,”
The device fits over a flexible endoscope and adds additional stabilization and improved visualization during incision-free endolumenal therapeutic procedures. Endolumenal treatment is different because it provides access to the therapeutic area within the colon through the anus. Because the procedure and treatment take place entirely within the intestine and there are no incisions through the skin, recovery time is reduced and the colon is preserved.
DiLumen consists of a single-use, soft flexible sheath that fits over standard and small-diameter endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. 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 endoscope.