FDA: We are happy to let you know that the United States Food and Drug Administration (FDA) has given us 510(k) Clearance for the DiLumen Is™ Endolumenal Interventional Scissors.
The latter are a sterile, single-use, disposable, monopolar electrosurgical device. It is being used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. This is the fourth device Lumendi has developed as the company continues to advance minimally invasive endolumenal therapies.
In December 2016 we informed you that the FDA gave us 510(k) Clearance for our first DiLumen product.
One year later our Chairman, Dr. Peter Johann, explained our plans for 2018 in a video. In April 2018 we informed you about the FDA 510(k) Clearance for DiLumen C2.
We continue to develop our technology for minimally invasive gastrointestinal surgery. As a result of these efforts, we are in the position to let you know that we have received clearance from the FDA for our DiLumen Is™ Endolumenal Interventional Scissors.
This is a sterile, single-use, disposable, monopolar electrosurgical device. It is being used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.
This is the fourth device Lumendi has developed as the company continues to advance minimally invasive endolumenal therapies.
Medical Advisor Meeting in Milano, Italy
During May 2018 we held a small workshop-type congress for medical doctors and experts regarding endolumenal therapies.
For this purpose we were at the Humanitas University, Faculty of Medicine. We had access to 4 stations with complete surgery equipment and facilities.
Sergey Kantsevoy, M.D., Director, The Center for Therapeutic Endoscopy reported about his many successful cases using DiLumen products with patients in Baltimore (USA).
Prof. Repici acted as host and discussion leader. He discussed the usefulness of DiLumen products when doing an Endoscopic Submucosal Dissection (ESD) and moderated the question and answer sessions.
We received positive feedback for our mini-congress. What experts liked in particular was the possibility for testing things themselves. Also appreciated were the advantages that manifested themselves when conducting the procedure but also patient benefits.
3. What is your opinion?
Your opinion matters to us. What are your thoughts?
- As a Lumendi Investor, how do you see the journey forward?
- As an expert that conducts endoscopic therapies, are you interested to take a DiLumen product for a test drive?
If your answer is yes, please let us know in a comment below.
- Do you have questions? We love to hear from you! We will answer you quickly.
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Good to know
Clearance as defined by the FDA is different than approval, but equally important. In order to get 510(k) clearance, the FDA does not require human trials to prove efficacy and safety, because such a device is considered to be at least as safe and effective as similar devices already on the market.
The manufacturer of a 510(k) device must demonstrate that the device has the same intended use and is substantially equivalent to similar legally marketed devices.
This makes the process simpler and faster, but no less important in helping to ensure public safety. It also means receiving clearance is no less of an achievement!
Find out more here.