Santa Claus bringt Lumendi das Weihnachtsgeschenk früher als geplant = FDA 501 (k) Clearance ERHALTEN |Fotolia #125884035 | Urheber: JenkoAtaman
Santa Claus visited our Lumendi LLC offices and left us a wonderful gift = FDA 510 (k) Clearance Received |Fotolia #125884035 | Copyright: JenkoAtaman

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

FDA says yes

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.

FDA Compliance - die FDA 501 (k) Clearance ist ein Muss |Fotolia #95751665 | Urheber: doc rabe media
FDA and Compliance –  FDA 510 (k) Clearance is a must  |Fotolia #95751665 | Urheber: doc rabe media

We will keep you posted about our progress in our blog here and of course, our newsletter.

If you have not subscribed yourself to our newsletter, do it right here so you will not miss future news we release

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.

Tidbit

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.

FDA Application: Lumendi receives Clearance

11 thoughts on “FDA Application: Lumendi receives Clearance

  • Guten Tag Herr Gattiker,
    Super news ! FDA 510 (k) in schon fast Rekordzeit , Bravo allen Beteiligten. Ein kleines Manko ist leider im Text vorhanden: 510 (k) wurde leider oft als 501 (k) geschrieben/bezeichnet. Das ist sicherlich ein Typo, sollte aber in so einem wichtigen statement nicht vorkommen, mindestens nicht so gehäuft.

  • Dear Mr Locher
    Thanks so much for leaving a comment on our blog.

    I also appreciate your praise and yes, the Lumendi team has worked wonders in a very short time. For that they deserve all the credit.

    I am always surprised how many very dedicated people are involved to make complex things happen quickly and properly.

    I also appreciate your comment pointing out the 510 error. I fixed that one and yes, it should not happen. But due to computer problems I got the press release too late… and it had to get out. Time pressure, no excuse…
    So whilst we used the four eye principle, we still missed it. For that I apologise.

    Respectfully
    Urs E. Gattiker

    1. Dear Mr. Gattiker,

      Please let us know more details regarding DiLumen, including the CE Mark and the distribution status in Greece & Middle East.

      Thank you for your attention.

      Kind regards,

      Thanos Mellos
      CEO
      NOVINIUM

      1. Dear Mr. Mellos

        Thanks so much for leaving your comment on our blog. I chose to answer you in 2 comments to 2 different issues.
        You asked

        Please let us know more details regarding DiLumen, including the CE Mark…

        Answer 1
        When you talk about the CE Mark you probably mean the abbreviation of French phrase “Conformité Européene”

        CE marking (European Commission)

        Just for those of us who do not necessarily know. The CE mark shows that our DiLumen product meets EU safety and health requirement and that it complies with EU legislation. In turn, it can be sold to hospital and clinics in the EU (Switzerland has its own requirements).

        My reply is: “One step at a time will get us there quicker than one giant leap…”

        Our small but maybe still big step 🙂 was getting FDA 510(k) clearance. Now you need to give us a bit of time to get our bearings…. work the marketing. But we will most certainly do the necessary things to get the CE mark to be able to sell in Europe.

        Hope this answers your question? Please drop me a line if I can help in any other way.
        Respectfully
        Urs

      2. Mr Mellos
        You also als asked:

        Please let us know more details regarding DiLumen, including … the distribution status in Greece & Middle East.

        Answer 2
        Elsewhere I wrote as an answer to one of the commenters in our blog:
        a two-year old company with a 1-year old sibling in the US – Lumendi

        We are very young as the above URL will explain further if you click on it.
        In turn, we have worked full-steam to get the product from the lab into the market. Nevertheless, our primary focus was, of course, on getting things ready to apply in August to the FDA for clearance.

        Quite frankly until then, other markets were not on our radar until we got our Santa Claus gift on December 6, 2016, the 510(k) clearance.

        I am certain, you are very much aware that getting things ready for submitting an application to the FDA is not just a leisurely morning jog. Instead, it took all our focus and energy. I hope you forgive us for that 🙂

        Now we want to use this clearance to introduce our product in the US market.

        See FDA Notice about Lumendi’s 501(k) clearance from December 14, 2016

        However, we are getting ready for Europe. We will post another blog entry regarding this as soon as we are ready to comment on that in public.

        But I took the liberty to sign you up for our newsletter and I will e-mail you personally after having completed this reply to follow up.

        I hope this information is satisfactory.
        Respectfully
        Urs

        1. Dear Urs,
          Thank you for your prompt reply.
          Please let me know about:
          – range of applications
          – scope compatibility
          for DiLumen.
          Look forward to working with you.
          Kind regards,
          Thanos Mellos

    1. Dear Thanos
      thanks again for following up. You write:

      What do you mean ”it can be used with any endolumenal device”

      The DiLumen is mounted like a sleeve on a conventional endoscope and permits clinicians to:

      • Stabilize the endoscope tip in relation to the intestinal wall
      • Create a therapeutic zone with improved visualization inside the intestine
      • Manipulate the colon wall to provide better access for treatment

      I hope this clarifies things a bit.
      Cordially
      Urs

  • Congrats to the team! Getting 510 (k) clearance in less than 100 days is a great achievement. Further I like to highlight the outstanding communication through your website.
    All the best for your product launch!
    Corina

    1. Dear Corina

      Thanks for taking the time to write a comment.

      I really appreciate your praise regarding our 510(k) clearance. Yes it was fast.
      But I think all the credit goes to the team. Lucky for us, several of our management team members and others have had lots of experience in their past jobs with getting FDA clearance and/or approval from the FDA. That really helped.

      I also appreciate your feedback in regard to our communication work that you find outstanding. It is not always easy to do well here. For starters, we work across the Atlantic. Moreover, our team members live in different countries and vastly different time zones.

      But we can handle these small obstacles…. no worries. What is tougher is finding the time. Like with any other start-up, each one of us has tons of work on our plate. Prioritising the right things is key. Having then a guy like me come around nagging for input, ideas, pictures or feedback on blog content is not really a priority or maybe it is?
      So far I am glad to report we seem to have managed fine and your feedback would indicate this. Thank you for letting us know.

      Have a nice day.
      urs
      #DrKPI

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