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  • Plicator Effectiveness Study

    LANDMARK STUDY IN GASTROENTEROLOGY PROVES EFFECTIVENESS OF PLICATOR™ PROCEDURE TO TREAT GERD

    Largest Randomized, Sham-Controlled Trial Finds Plicator Procedure Significantly Reduces GERD Symptoms, Medication Use and Esophageal Acid Exposure

    Mansfield, Mass.—September 5, 2006—NDO Surgical, Inc. today announced publication of a landmark study proving the safety and efficacy of the Plicator procedure to treat gastroesophageal reflux disease (GERD). The study, published in the September 2006 issue of Gastroenterology is the largest randomized, sham-controlled trial for an endoscopic GERD therapy. The findings show the Plicator significantly reduces GERD symptoms, PPI medication use and esophageal acid exposure compared to a sham procedure. It is the first outpatient GERD procedure to significantly improve all three factors.

    The 15 site study was led by Dr. Richard Rothstein at Dartmouth Hitchcock Medical Center. It involved 159 blinded patients randomly assigned to either the Plicator group or a sham treatment group which mirrored the active procedure with the exception of the deployment of the Plicator suture-based implant. The primary endpoint was a reduction in GERD symptoms based on a GERD health related quality of life questionnaire. Three months post-procedure, 65 percent of Plicator patients achieved greater than 50 percent improvement in GERD symptom score, compared to 20 percent in the control group under the per protocol analysis.

    The study also showed that medication use, esophageal acid exposure, quality of life and heartburn severity were significantly improved following Plicator treatment; 62 percent of patients treated with the Plicator eliminated daily PPI medication use.

    “Physicians treating patients with GERD have been awaiting solid scientific evidence demonstrating that endoscopic procedures for GERD are, in fact, a safe and effective treatment option,” said Dr. Richard Rothstein, Section Chief, Gastroenterology & Hepatology, Dartmouth Hitchcock Medical Center, and Professor of Medicine at Dartmouth Medical School. “With this sham-controlled trial, the Plicator procedure is now proven to reduce PPI medication use, esophageal acid exposure, and symptoms, which sets it apart from the other endoscopic treatments that have been used to treat GERD.”

    “This study further validates the Plicator procedure’s efficacy and safety profile,” said Patricia Hennessey, Chief Commercialization Officer at NDO Surgical. “The definitive results from this research confirm that the Plicator is an effective treatment for many patients whose symptoms are not controlled by medication and who are seeking to improve their quality of life.”

    The Plicator procedure is a minimally invasive treatment for GERD, a disease typically characterized by chronic heartburn. The Plicator procedure may provide relief for GERD sufferers desiring an alternative or adjunct to pharmaceutical treatment. The Plicator procedure requires no surgical incisions and is performed under conscious sedation, allowing for rapid recovery.

    About the Plicator
    NDO Surgical’s Full-Thickness Plicator is an FDA-cleared, endoscopic GERD treatment based on the proven principles of anti-reflux surgery. Through a simple, outpatient procedure, the Plicator is used to grasp, fold, wrap and fixate tissue at the junction between the esophagus and the stomach, thus tightening the valve that acts as a barrier to gastric reflux. The Plicator is the only endoscopic GERD treatment that mimics tissue restructuring performed during anti-reflux surgery. Clinical studies have shown the Plicator procedure to be effective in reducing symptoms, medication use and acid levels in the esophagus associated with GERD.

    About NDO Surgical
    Based in Mansfield, Mass., NDO Surgical is a privately held medical technology company dedicated to the development of innovative endoscopic technologies for gastrointestinal diseases. Additional information is available at the Company’s website at [url]http://www.plicator.com[/url].

  • #2
    From what i hear this surgery is no good lol..hmmmm

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    • #3
      The Plicator

      dau...in reading this information on the Plicator, ( [url]http://www.ndosurgical.com/[/url] ) it said...

      "In a multi-center clinical study, the Plicator procedure was shown to be effective in eliminating the need for prescription heartburn medications in 70% of treated patients out to at least 1-year post-procedure. In addition, 80% of patients treated with the Plicator experienced a reduction in the amount of gastric acid allowed to enter the esophagus."

      What happens after the 1 year??? Back on meds??? GERD back????

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      • #4
        Originally posted by LSAT
        ...What happens after the 1 year??? Back on meds??? GERD back????
        Beats me. Maybe they will have a follow-up study....it looks promising but 1 year isn't much to brag about. I will be requesting a copy of the study as soon as that particular journal gets into the medical library sysytem.

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        • #5
          Art didnt fair to well i havent heard most postive on this..

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          • #6
            Moquer has been very happy with his plicator and has had it now for, what, two years? Dr. Sedghi outside of Atlanta performed his.

            I went and saw Anthony Starpoli in NYC -- he had only done THREE (wish they had told me that when I made the appt. lol). b

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            • #7
              buffy

              Hi Buffy. What did you discuss with Starpoli? What were your impressions?

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              • #8
                so if the plicator fails you could still hav the nissen,or the the new esphox thats coming out..i thought somebody from the board did horribly from the plicator??

                what are the main side effetcs of the plicator?

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                • #9
                  Miss J - I am the one who asked how many plications Starpoli had done -- he did not volunteer that information. Then there were other personal things that I didn't care for.

                  Trailor - if you want plicator info, you may want to contact Dr. Sedghi's office (I think his secretary's name is Mina). It is my understanding that he has done more of these procedures than anybody else in the U.S. His office can send you information. Moquer had had two Nissens and an endocinch procedure before he saw Dr. Sedghi. He told me that the recovery from the plicator was the easiest of all procedures -- I think it was a soft diet for a week.

                  Yes, there was one person who had the plicator and had complications from it -- and I believe it was Dr. Raijman who performed that procedure. Dr. Raijman was the same doc that did the endocinch on Moquer, and Moquer had no problems with it at all. Makes me wonder if the problem was the patient's anatomy, or the doctor's skill, or the equipment... I don't think anybody will ever really know.

                  I questioned my surgeon about the newer procedures, and at the time, he offered me the endocinch, but he did say --as did Mayo-- that they just don't know what will happen long term with these new procedures, so I opted for the surgery. I am wondering if this is going to be the long term fix for Moquer -- as his body might be scarring things together, forming a tighter, long term closure. I sure hope so.

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                  • #10
                    buffy

                    Hi Buffy. Did you also speak with Dr. Sedjhi also? Or, have you definitely decided against the plicator? Jenn

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                    • #11
                      This procedure seems ok,as long as there is no long term damage,and you can have another surgery down the road if needed..Any Drs do it the Chcago area??

                      what are the percentages so far its early but what are they anyone know?

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                      • #12
                        Jenn - I didn't go as far as speaking with Sedghi -- although he did tell his secretary that he would look at all of my records and speak with my otolaryngologist.

                        I think the question for Sedghi would be 'How many of these have had a successful fundoplication afterwards....and which surgeon performed the fundoplication post plication? b

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                        • #13
                          Maybe with the Esphox,and Plicator maybe one day we will be closer to a operation that more effective,less invasive,and better healing outcome.i dont like the Idea of taking PPIs and still feeling like crap forever..
                          TM

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