Lumendi Submits Premarket Notification to US FDA For DiLumen C2™ and the DiLumen Is as Part of its Second Generation Endolumenal Interventional Platform

WESTPORT, CONN, November 10, 2017 – Connecticut-based medical device innovator Lumendi, LLC ( continues to advance minimally invasive endoscopic therapies with the addition of its DiLumen Ig Endolumenal Interventional Grasper that is now available in the United States. The DiLumen Ig is a flexible endoscopic tool intended to grasp and manipulate tissue within the digestive tract under direct endoscopic visualization. In addition, Lumendi has submitted a Premarket Notification to the United States Food and Drug Administration (FDA) for the DiLumen C2 and the DiLumen Is.

DiLumen C2 EIP, the second generation Endolumenal Interventional Platform (EIP), is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment. The DiLumen Is Endolumenal Interventional Scissors are a sterile, single-use, disposable monopolar electrosurgical device intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. All three devices were developed by Lumendi in collaboration with the Minimally Invasive New Technologies program (MINT) at Weill Cornell Medicine and New York-Presbyterian.

“The DiLumen™ family of devices facilitates endoscopic treatment of colonic lesions, such as polyps, a common condition that affects millions worldwide, and may replace open surgical or laparoscopic procedures, potentially reducing healthcare costs,” said Dr. Peter Johann, CEO, Lumendi, Ltd.

DiLumen C2 EIP is a pioneering technology that stabilizes an endoscope to better facilitate incision-free endolumenal therapeutic procedures. For the first time, two 6mm working channels allow additional therapeutic instruments to be utilized in interventional procedures simultaneously with traditional endotherapy devices that are used through the endoscope’s own working channel. With the introduction of two additional instruments, previously technically difficult and time-consuming procedures can potentially be improved.

The DiLumen Ig and DiLumen Is will be used in conjunction with the DiLumen C2 to expand the capabilities of tissue management necessary to facilitate many intralumenal procedures. Adequate tissue manipulation and traction combined with effective cutting, dissecting and cauterizing continue to be a major challenge for therapeutic procedures in the digestive tract. These new Endolumenal Interventional Instruments are based on Lumendi and MINT’s initiative to migrate many gastrointestinal surgeries to endolumenal procedures.

DiLumen C2 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 can extend in front of the tip of the endoscope once at the lesion site. 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. With the addition of two working channels for DiLumen Ig and DiLumen Is, tissue can be manipulated, cut and dissected in a way that may better enable access and removal of lesions during endolumenal interventions.

“With the successful introduction of DiLumen EIP earlier this year, DiLumen C2, Ig and Is are the next logical steps in a family of devices to continue the process of enhancing endoscopic treatment. Lumendi continues its commitment to improving endolumenal interventions and is committed to expanding treatments that lead to effective, less-invasive procedures that may ultimately improve patient care,” said Dr. Johann.


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