Home Fairfield Lumendi’s endoscopic surgery accessory approved by FDA

Lumendi’s endoscopic surgery accessory approved by FDA

The DiLumen C2 from Lumendi

Westport medical device manufacturer Lumendi has received U.S. Food and Drug Administration 510(k) clearance for its DiLumen C2.

The device is a second-generation endoscopic surgery accessory that can be used to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment. Lumendi’s first surgical accessory, the DiLumen, was approved in late 2016.

Fitting over a standard endoscope, it allows surgeons better stabilization and visualization within the intestine, facilitating endolumenal procedures in the removal of large or complex polyps. The company said the C2 is similar in design to its Endolumenal Interventional Platform [EIP] as both feature two balloons used for creating a stabilizing therapeutic zone inside the colon during endolumenal interventions.

The C2 incorporates two 6mm diameter tool channels, which accommodate two independent flexible articulating hand instruments. The C2, along with other Lumendi flexible-articulating instruments, can create a unique therapeutic platform that will further enable clinicians to perform complex procedures completely within the colon without open surgery, according to the firm.

“To date, we have completed over 350 procedures with the commercially available DiLumen EIP with no serious adverse events,” Lumendi CEO Dr. Peter Johann said. “Three clinical studies have also been completed, further demonstrating safety and cost effectiveness.”

Those studies are expected to be published in the near future, he said.

2 COMMENTS

  1. I am a 51 year old female that just found out I have Motor Neuron Disease Parkinson’s about a year and half, but I have been having signs of it for years, tremors, depression, body weakness. ECT. I honestly don’t think my doctor was reading the signs because of my gender and age. A few years ago I had my shoulder lock up on me and I was sent to a P.T since x-rays didn’t show any physical damage. My shaking was getting worse and I began falling. Only when my speech became so bad that it brought concern to my dentist was Parkinson’s even considered. He phoned my doctor with his concerns about my shaking and balance problems. By this time I was forgoing shots in the back of my neck for back and neck pain to which once again I was sent to a P.T (although x-rays showed no damage) I was told I had a few spurs which were most likely causing the pain. Here I was feeling like my whole body was falling apart and doctor could not find anything wrong, maybe in was all in my head? My doctor even seemed annoyed with me and things just kept progressing and I just kept it to myself, why bother going through testing and them finding nothing? Well, it was after my second P.T called my doctor about the weakness in my legs and arms, by this time I have developed a gait in my walk and I fell more frequently. Only then did my doctor send me to a specialist and it was found that I had Parkinson’s, and that I have had it for awhile. I think because I was a woman that my signs and symptoms weren’t taken seriously and therefor left untreated for so long,I was taking pramipexole dihydrochloride three times daily, I Was on carbidopa levodopa but only lasted 90 minutes then wore off.I found that none of the current medications worked effective for me.I got tired of using those medication so I decided to apply natural herbs formula that was prescribed to me by my second P.T, i purchase the herbal formula from totalcureherbsfoundation. com, There has been huge progression ever since I start the treatment plan which will last for 15 weeks usage.all the symptoms and sign has begin to disappear .

LEAVE A REPLY

Please enter your comment!
Please enter your name here