Nova Sure: A new device for Endometrial Ablation

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Hans van der Slikke, MD: "It's September 2001, and we're in Paris at the Controversies in Gynecology and Obstetrics Conference. Next to me is Professor Jay Cooper who is from Phoenix, Arizona and he is the President of the AAGL, which is the American Association for Gynecological Laparoscopists. Welcome, Professor Cooper."

Jay Cooper, MD: "Thank you, it's nice to be here. It's a lot cooler here than Phoenix is at this time of year."

Hans van der Slikke, MD: "I believe you but we're going to talk about a hot topic and that's heavy bleeding in pre-menopausal women. There are several ways to treat this disease and if you don't treat it with hormones then there are several other ways like hysterectomy. Nowadays we have better instruments and better technologies to do it otherwise, could you explain some of the newer methods we have now, Professor Cooper?"

Jay Cooper, MD: "Certainly, I think the issue of abnormal bleeding or excessive menstrual bleeding is one that's unfortunately underestimated. At least in my practice, second to complaints of vaginal irritation or vaginitis, complaints of abnormal bleeding are the most common reasons that women visit with me, and it's particularly annoying for women who have completed their family. It seems to me that during the years when a woman is having children the menstrual period seems to have a meaning and a function but once you're beyond those years, and as women increasingly enter the workforce at least in the U.S., the problems of heavy menstrual bleeding become rather severe. Women often complain of being unable to attend a meeting because they're afraid they'll stain their clothing, and so it's a real problem. We've had hormone therapy for years and we've used birth control pills, off label so to speak, instead of for their contraceptive purposes we've used them to help control heavy bleeding. We've always had the true tried hysterectomy and there's no doubt that a hysterectomy will stop menstrual bleeding but increasingly medical device companies are looking at these less invasive and easier to perform technologies or procedures that offer women the opportunity to have the heavy bleeding controlled but to not face the risks associated with hysterectomy and to be able to return to their normal activities within just a matter of a day or two. In that regard, a procedure that perhaps avoids the need for general anesthesia, that can be done in an office setting, is non-incisional, and they can return to work within a day or two becomes an attractive alternative to hysterectomy."

Hans van der Slikke, MD: "Today you presented a paper about such a simple technology."

Jay Cooper, MD: "Yes, we talked about Nova Sure. It's one of the new global, and I call this global versus the traditional hysteroscopically directed endometrial ablation technologies, and it's a rather easy procedure to perform and the learning curve for doctors is very short. After being mentored or proctored for a few cases, physicians are likely to be very skilled at this procedure and be able to get excellent results and results that are durable. What's very important with endometrial ablation, which means destroying the lining of the uterus, is to have a technology that not only works in the short-term but long-term as well. What we're finding with these new global ablation technologies is that they are as durable as is traditional endometrial ablation and if they're as durable, easier to perform, perhaps safer, and the learning curve is shorter, perhaps more and more physicians will make them available to their patients."

Hans van der Slikke, MD: "In what percentage of the treatments is it effective - a hundred percent?"

Jay Cooper, MD: "It would be nice wouldn't it if it were always effective, that's not the case, of course. In the clinical trial that was just recently completed in the United States the effectiveness was well in excess of 95%. When we talk about effectiveness, we are talking here about reduction in menstrual bleeding scores. To objectify this to allow a precision to a clinical trial that wouldn't exist necessarily in clinical medicine, we actually measured how heavily a woman was bleeding with three menstrual periods prior to the performance of the ablation procedure. Then for a year thereafter we measured their menstrual bleeding as well and we found that there was a dramatic reduction in the amount of bleeding. In fact, 45% of patients stopped bleeding altogether - no further bleeding at all despite the fact that they weren't menopausal. Their hormonal activity continued but there was no further bleeding."

Hans van der Slikke, MD: "This seems one of the most effective techniques and this is also very easily done."

Jay Cooper, MD: "Yes, it is very easily accomplished. I think the simplicity of the procedure is in contradiction perhaps to the sophistication to the highly engineered device. It's a very interesting and sophisticated device but I guess the best technologies are those that are sophisticated and effective but when they're used they appear to be very simple and that anyone can use them. I think that's pretty much the case here."

Hans van der Slikke, MD: "Thank you very much for explaining this, Professor Cooper."

Jay Cooper, MD: "You are very welcome."