Medical device developer Lumendi said today it won FDA 510(k) clearance for its DiLumen endoscopic accessory.
The Connecticut-based company’s DiLumen device is now indicated for use in positioning endoscopes in the large intestine and assisting with optical visualization, diagnosis and endoscopic treatment.
Lumendi’s endolumenal interventional platform is designed to enhance and facilitate the diagnosis and treatment of colorectal disease through a less invasive approach.
“DiLumen is the 1st step in a family of devices to enhance endoscopic treatment, including many promising endolumenal therapeutic procedures, that may ultimately improve patient care. Lumendi sees a great potential in endolumenal interventions and is committed to build on this opportunity,” CEO Dr. Peter Johann said in a prepared statement.
Building on the license they received from Cornell in 2014, Lumendi has secured FDA clearance for DiLumen (the MINT technology formally known as ESP).
The Dilumen is an endoscopic accessory, which is intended to help with positioning an endoscope in the large intestine and includes a single-use, soft flexible sheath that fits over standard and small-diameter colonoscopes. It utilizes two balloons – one behind the bending section of the colonoscope and the other in front of the tip – to help create “therapeutic zones” that allow for better visualization of lesions.
These zones are created after the balloons are deployed and inflated in a patient’s intestine. The device helps stretch out the intestinal wall and straighten folds and bends, aiding in visualization. Upon the conclusion of the procedure, the balloons are deflated and removed with the colonoscope.
As one of the original inventors, Dr. Jeffrey Milsom, co-director at MINT has been involved in the development of the technology over a number of years. When talking about the recent developments Dr. Milsom said:
“DiLumen’s use during flexible colonoscopy is a major technical advance in a field that has previously been defined by laparoscopic and open surgical procedures. DiLumen can stabilize a section of colon and may make it easier to remove complex adenomas or polyps, with the potential to positively impact patient outcomes. Although reporting of results in patients awaits clinical studies, we are extremely confident that this technology will be transformative in treating digestive diseases.”
Core principles are focused on improving safety, reducing complications, and enabling new approaches to therapy, resulting in shorter hospital stays and a faster return to normal activity for patients.
These surgical tools and clinical improvements will also provide economic value to the healthcare system as patients recover faster and return to their daily lives sooner.
Lumendi’s patented balloon overtube technology is designed to create a therapeutic zone within the large intestine that:
- stabilizes the endoscope tip in relation to the intestinal wall,
- increases visualization – especially around bends and folds,
- expands the colon wall, flattens folds and straightens flexures, and
- enables fast local insufflation.