The DiLumenTM Endolumenal Interventional Platform
The large intestine is a long, winding, flexible tube with many folds filled with fluid and stool. Most diseases of the colon that require intervention are relatively easy to treat; however, some are difficult to access or visualize making it difficult or impossible to treat endoscopically. In these circumstances patients are often referred to gastrointestinal surgeons who may rely on invasive surgery to perform treatment.
Developed through collaboration between Lumendi LLC and the Minimally Invasive Technologies program (MINT) at Weill Cornell Medical Center and New York-Presbyterian Hospital, DiLumen, when used as directed creates an isolated, stabilized Therapeutic Zone (TZ) within the intestine that straightens the target area and flattens the folds so clinicians can see and treat isolated segments of the bowel.
Q. HOW DOES THE DILUMEN PLATFORM WORK?
- DiLumen is a disposable dual-balloon accessory that fits over commercially available endoscope, without inhibiting endoscope functionality.
- DiLumen’s soft flexible sheath 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, the area between the balloons is stabilized which creates the Therapeutic Zone (TZ). Creating the TZ allows the clinician to flatten folds in the large intestine and expose lesions for diagnosis and treatment. Establishing the TZ assists with visualization, stabilization, insufflation (blowing gas to inflate the intestine) and manipulation of the tissue to enable the clinician to treat the isolated bowel segments. Once the therapy is completed, the balloons are deflated and removed along with the endoscope.
Q. WHAT ARE THE INDICATIONS FOR DILUMEN?
- Lumendi received FDA 510(k) clearance for the DiLumen Endolumenal Intervention Platform on December 6, 2016. DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
Q. WHAT IS THE THERAPEUTIC ZONE (TZ)?
- The Therapeutic Zone is the stabilized section of large intestine between DiLumen’s two balloons when they are deployed and inflated. The balloons assist with accessing and visualizing lesions behind folds and turns in the large intestine, stabilizing the endoscope’s distal tip and allowing localized insufflation (blowing gas to inflate the intestine) within the TZ. Once the therapy is complete, the balloons are deflated and removed along with the endoscope.
Q. WHAT IS ENDOLUMENAL THERAPEUTIC TREATMENT?
- Endolumenal therapeutic treatment is performed in a hollow organ using typical techniques, such as retraction, dissection and tissue apposition (clipping or stapling) under endoscopic control. In the gastrointestinal tract, this treatment is performed through natural orifices and involves a camera mounted on the end of a tube or endoscope as well as small therapy devices, such as needles and electrocautery to lift, dissect, control bleeding and remove tissue.
- The time of the procedure can vary from one to several hours. General anesthesia may or may not be necessary depending on the complexity of the procedure and the clinician’s preference. Insufflation with gas is also used to inflate the bowel and improve visualization; however, inflation of only a portion of the large intestine (only the area within the Therapeutic Zone) with DiLumen helps minimize bloating and discomfort following the procedure.
Q. HOW IS ENDOLUMENAL THERAPEUTIC TREATMENT DIFFERENT FROM LAPAROSCOPIC SURGERY?
- While laparoscopic surgery is a significant advancement over open surgery, it still requires the use of general anesthesia and small incisions to access the abdominal cavity. Though the risk of complications is lower and recovery time is shorter than open surgery, it still may require an extended hospital stay and a long recovery. This is especially the case with colorectal surgery. Endolumenal therapeutic treatment is different in that access to the targeted organ is through a natural orifice (such as the anus) and takes place entirely within the lumen (the inside of a tubular space, such as the intestine), with the removal of diseased tissue occurring via the natural orifice. This procedure avoids an incision through the skin, and the recovery necessary from such an incision.
Q. ARE THERE ANY COMPLICATIONS OF ENDOLUMENAL THERAPY?
- There are potential complications with any procedure. With endolumenal therapy, these may include perforation of the bowel, infection and bleeding, most of which can be adequately managed during the procedure.
Q. WHO IS CREDENTIALED TO PERFORM ENDOLUMENAL THERAPY?
- Advanced endoscopists and surgeons with experience in flexible endoscopy will be the primary users of DiLumen.
Q. HOW MANY ENDOLUMENAL THERAPEUTIC PROCEDURES ARE PERFORMED ANNUALLY IN THE U.S.? WORLDWIDE?
- Hundreds of thousands of these procedures are performed each year. In certain countries like Japan they are considered the gold standard. DiLumen has the potential to expand this trend in the U.S. and abroad.
Q. WHEN WILL DILUMEN BE AVAILABLE?
- DiLumen has been available in the U.S. since May 2017 and is now available in Europe.
Q. WILL DILUMEN BE COVERED BY INSURANCE? WHAT WILL BE THE COST TO THE SURGEON? WILL DILUMEN INCREASE PATIENT CO-PAYS?
- In the U.S., endolumenal therapeutic procedures currently are covered by Medicare, Medicaid and most private health plans.
Q. WHO IS LUMENDI?
- Lumendi is a privately held, innovative medical device company focused on developing, marketing and distributing surgical tools and devices that provide safe, cost-effective solutions for minimally invasive gastrointestinal procedures. DiLumen is the first device Lumendi is bringing to market.