From Surgery to Endoscopy:

The Growing 3 Adoption of Endolumenal Intervention to Remove Benign Colon Polyps

James White, DO, Vice President, Medical Affairs, Lumendi

Recently, several improvements have been made to DiLumen based on the feedback of the more than 60 clinicians that have used it over the past year.

THE COLON is a long, winding, narrow, tubular organ with many folds. It actively moves large quantities of fecal matter from the small intestine to the rectum. Due to factors such as these, many polyps are difficult to access via colonoscope for safe removal. As a result, clinicians often rely on invasive surgery to eradicate disease by resecting a portion of the colon to remove the polyp and then sewing the remaining sections together.

In late 2016, Lumendi., a medical device company headquartered in the U.K., received clearance in the US for an innovative technology specifically designed to assist in removing large benign polyps from the colon, thus obviating the need for surgical intervention. The new device allows for expansion of a less invasive treatment paradigm: endolumenal intervention. While hundreds of thousands of these procedures are performed globally each year¹, the shift to endolumenal intervention is now gaining momentum in the United States and Europe.

Endolumenal Intervention – Many Potential Advantages Endolumenal intervention is a procedure performed within a hollow organ (like the gastrointestinal tract) using well-establishedtechniques, such as retraction, dissection and suturing, under endoscopic control. It is different from laparoscopic surgery – which saw rapid adoption in the 1990s – in that it accesses the targeted lesion for therapeutic treatment through a natural orifice, such as the anus², takes place entirely within the lumen without the need for skin incisions, and may involve the removal of diseased tissue via the natural orifice. As a result, endolumenal intervention preserves the patient’s anatomy and can significantly help increase patient safety, reduce the need for general anesthesia, increase the number of patients eligible for treatment, significantly shorten hospital stays (often to same day), reduce financial costs, and improve patient outcomes. While there are potential complications with any procedure, they are likely to be less significant with endolumenal intervention than with traditional or laparoscopic surgery.

The DiLumen EIP™ (Endolumenal Intervention Platform) has been used in close to 800 endolumenal gastrointestinal procedures in the US and parts of Europe³. It is used primarily as an organ-preserving endoscopic accessory for tissue manipulation and resection, opening the door to more widespread adoption of endolumenal intervention. Importantly, DiLumen

creates an isolated, stabilized Therapeutic Zone (TZ)4 within the intestine. It straightens the target area, limits fluid and stool, and flattens the folds so clinicians are better able to see and treat isolated segments of the bowel, thus preserving the colon.

“DiLumen gives me both the stability and tissue retraction necessary to facilitate a safe and complete removal of these complex polyps, preserving patients’ anatomy, and saving them the possibility of having to endure a surgical resection,” said Professor James East, MD, John Radcliffe Hospital in Oxford, England.

This is the first device based on the Lumendi initiative to help migrate many gastrointestinal surgeries to endolumenal procedures. The DiLumen EIP, which is intended for use with any standard colonoscope or gastroscope; is a single-use, close-fitting sleeve that fits securely over a standard endoscope. As a dual-balloon accessory, it is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and treatment to enhance performance during endolumenal treatment.

According to Jeffrey W. Milsom, MD, Chief of Colon and Rectal Surgery at NewYork- Presbyterian/Weill Cornell Medical Center and inventor of the DiLumen EIP, “Colon polyps can no longer escape prying eyes. The endoscope is somewhat free-floating inside the intestine; something like a boat on the water, it bobs up and down. The DiLumen stabilizes the endoscope and makes it easier to navigate through the intestine, like a boat moored to a dock.”

New Innovative Devices

Lumendi continues to develop additional innovative devices in the evolution of the DiLumen. In April 2018, Lumendi received US FDA clearance for the DiLumen C2™. Similar in design to the DiLumen EIP, the DiLumen C2 incorporates two 6 mm diameter tool channels, which accommodate two independent flexible articulating hand instruments. These instruments are designed to further improve tissue manipulation, cutting and coagulation in a much safer, faster, and simpler method.

DYNAMIC RETRACTION OF TISSUE DURING POLYP RESECTION, A NEW FEATURE OF DILUMEN, IMPROVES ACCESS TO THE SUBMUCOSAL PLANE IN A SAFE AND EFFECTIVE WAY.

“Recently, several improvements have been made to DiLumen based on the feedback of the more than 60 clinicians that have used it over the past year. These improvements include changes to enhance endoscope navigation, but, more importantly, we’ve incorporated a new retraction system that can be attached to tissue and manipulated to lift and retract during polyp resection,” said Dr Peter Johann, CEO. This new system is a unique feature of the DiLumen EIP and is a new component of the fore balloon assembly, which can be moved back and forth during a procedure.

The Need for Screening Colonoscopy

Incidence/Prevalence Across the WHO European Region

  • In Europe5, colorectal cancer is the second most common cause of cancer death in both men and women. It is the second most common form of cancer in women, after breast cancer, and the third most common in men, after lung and prostate cancer.
  • In 2008, there were 450,000 new cases of colorectal cancer and 232,000 deaths in the WHO European Region.
  • Across the WHO European Region, deaths from colorectal cancer have fallen since the 1990s from 20.36 per 100,000 population in 1995 to 18.86 per 100,000 in 2009.
  • Screening colonoscopy is the single best way to prevent colon cancer. Depending on the country, individuals are urged to have their first screening colonoscopy between their early ‘40s and mid ‘50s. Additional screenings may be required every few years should adenomas be detected.

Contact

Michael Augsberger, SVP International Lumendi Ltd
Address: Abbey Place, 24-28 Easton St, High Wycombe, Buckinghamshire, HP11 1NT England
Phone: +44 20 3109 0312 http://www.lumendi.com

  1. In certain countries like Japan, endolumenal treatment is quite frequent and surgery for benign polyps is virtually non-existent.
  2. In the gastrointestinal tract, endolumenal treatment should be performed via natural orifices and involves the use of a camera mounted on the end of a tube or It also utilizes small therapy devices such as needles and electrocautery to lift, dissect, control bleeding and remove tissue.
  3. DiLumen received CE Certification and identifies the device with the CE Mark to indicate it conforms with essential requirements of Council Directive 93/42/EEC concerning medical Lumendi’s EU distribution network is currently being developed, with distributors in Italy, Britain, Switzerland and Spain selected.
  4. When both balloons are deployed, and inflated, a stable Therapeutic Zone (TZ) is 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 colonoscope.
  5. Source: WHO European Region http://bit.ly/2HVN4tC
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