In Short: Lumendi has an other important milestone.
The company has received clearance from the US Food and Drug Administration (FDA) to market and sell DiLumen.
German Version / Deutsche Version hier
The last day of August 2016, we submitted our application to the FDA. We were applying for a 510(k) clearance from the FDA. Within just 97 days we got a positive reply from FDA, clearing us to start selling the product.
Here you can read our press release that got distributed today (our Chairman informed our German blog readers here):
Connecticut-based medical device innovator Lumendi, LLC has announced it has received United States Food and Drug Administration (FDA) 510(k) clearance for the DiLumen™, an endoscopic accessory that is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment.
DiLumen is a pioneering technology that stabilizes a colonoscope to better facilitate incision-free endolumenal therapeutic procedures, which are complex procedures utilizing a flexible colonoscope and therapeutic devices inserted into the colon to locate and treat diseased tissue while preserving the colon. The device was developed by Lumendi in collaboration with the Minimally Invasive New Technologies program (MINT) at Weill Cornell Medicine and New York-Presbyterian. It is the first device from the Endolumenal Interventional Platform based on Lumendi and MINT’s initiative to migrate many gastrointestinal surgeries to endolumenal procedures.
According to Dr. Peter Johann, CEO of Lumendi, Ltd.,
DiLumen is the first step in a family of devices to enhance endoscopic treatment, including many promising endoluminal therapeutic procedures, that may ultimately improve patient care. Lumendi sees a great potential in endolumenal interventions and is committed to build on this opportunity.
DiLumen facilitates endoscopic treatment of colonic lesions such as polyps, a common condition that affects millions worldwide. Such treatments may take the place of open surgical or laparoscopic procedures, potentially reducing healthcare costs.
DiLumen consists of a single-use, soft flexible sheath that fits over standard and small-diameter colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. 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 colonoscope.
“DiLumen’s use during flexible colonoscopy is an important technical advance in a field that has previously been defined by laparoscopic and open surgical procedures. DiLumen can stabilize a section of colon and facilitate the endoscopic removal of complex adenomas or polyps, with the potential to positively impact patient outcomes. Although reporting of results in patients awaits clinical studies, we are extremely optimistic that this technology will be transformative in treating digestive diseases,”
said Jeffrey Milsom, M.D., Chief of Colorectal Surgery at New York-Presbyterian/Weill Cornell Medical Center and Co-Director of the MINT Program, and the Jerome J. Decosse, MD, Distinguished Professor of Surgery at Weill Cornell Medicine. Dr. Milsom is a co-inventor of DiLumen and a paid member of a clinical advisory board for Lumendi, Ltd.
510(k) Clearance from the FDA: Implications
Getting 510(k) clearance for our DiLumen is critical. It allows us to go ahead and market the product in the US.
Without FDA Clearance we were so far unable to do any marketing for DiLumen (our product). Thanks to getting the 510(k) clearance, this is now a thing of the past. We are now permitted to start getting our product into hospitals and clinics.
As well, we can now explain the product’s benefits to all of you that are interested to hear. Patients, surgeons and insurers will want to benefit from DiLumen.
We will keep you posted about our progress in our blog here and of course, our newsletter.
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Questions? Have your say
We hope that you are as excited as we are about this early Christmas surprise we received.
Do you have questions or comments… Just post them below and we will answer you for sure.
Only 5% of devices are cleared via Abbreviated 510(k) submissions.
According to the FDA:
Device manufacturers may choose to submit an Abbreviated 510(k) when:
- a guidance documents exists,
- a special control has been established, or
- FDA has recognized a relevant consensus standard.
An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87 [Traditional 510(k)]. However, in an Abbreviated 510(k) submission, firms elect to provide summary reports on the use of guidance documents and/or special controls or declarations of conformity to FDA recognized standards to expedite the review of a submission.