Take a tour of the trade booths at AAGL '99

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Dr. Ellis Downes: “Barbara, it’s great to be here in Las Vegas at the AAGL meeting. It’s one of the biggest meetings in the world of gynecological endoscopists, and here we are at the OBGYN.net booth which has got a great deal of information, excitement, and people have been dropping by to see what’s going on. I’m with Barbara Nesbitt, who’s the Editor of OBGYN.net, and many of you know Barbara. Barbara, how do you feel the shows going?”

Barbara Nesbitt: “I think it’s fantastic. It’s not as large as last year but it’s livelier, and there’s more worldwide participation from physicians. I think it’s a great show.”

Dr. Ellis Downes: “There’s been some terrific scientific presentations that we’ve seen over the last few days that we’re particularly interested in. Instead of my normal Hospital Cuttings, I want to take the readers of OBGYN.net around the trade show to see what I think are some exciting, innovative products, which are coming on the way. So let’s take a trip, and let’s see where we’re going.”

Barbara Nesbitt: “Let’s go – OBGYN.net on the floor!”

Dr. Ellis Downes: “We’re over here at the InnerDyne booth. I’m here with Barbara and with Ted Belleza from InnerDyne to see really what’s happening on their stand. Ted, what’s new?”

Ted Belleza: “What’s new is that the FDA recently allowed InnerDyne to make expanded claims relative to the safety of our device when used in laparoscopy. To give you some historical background - in 1996 the FDA requested that all manufacturers of trocars rescind or withdraw the safety label when used with their conventional trocars. InnerDyne responded to the FDA in a letter, asking that we be allowed to make that claim - a claim to safety reduction and complications from use of our products, and submitted data from eight multi-center studies over 800 cases.”

Dr. Ellis Downes: “So you had over 800 patients?”

Ted Belleza: “Yes, 800 patients.”

Dr. Ellis Downes: “That’s a big study, Ted.”

Ted Belleza: “A big study and that data base has now grown to over 8,000 cases but the bottom line is the FDA in January allowed us to make nine claims, the most important of which is that when Step is used in a laparoscopic procedure, the incidence of major complications and minor complications is significantly reduced.”

Dr. Ellis Downes: “That has incredible implications for gynecologists. How do you think we should react to that?”

Ted Belleza: “Right now we are making gynecologists or laparoscopists be aware of the safety claim. As a matter of fact, The Journal of Gynecologic Endoscopy, in December, will be coming out with a proceedings of a recent meeting in which several experts from all over the world - including you who had participated - came up with a consensus statement. That consensus being that if you wanted to avoid trocar entry related complications, the first choice should be InnerDyne Step System.”

Dr. Ellis Downes: “Barbara, for a surgeon trocar insertion is a really tricky issue and this is time that…”

Barbara Nesbitt: “For a patient it is too.”

Dr. Ellis Downes: “That’s an even bigger problem. Certainly it’s very exciting here at InnerDyne that the evidence that they’ve submitted to the FDA has been so well received. Ted, I think this is exciting work that you’re doing at InnerDyne, and we look forward to seeing how your trials are going. Thanks so much for taking a minute to talk to us.”

Ted Belleza: “You’re welcome.”

Barbara Nesbitt: “We’re very happy to have you as a sponsor of OBGYN.net.”

Ted Belleza: “My pleasure.”

Barbara Nesbitt: “You’ve been with us a long time, thank you.”

Dr. Ellis Downes: “We’ve come over to the Microsulis stand to really see what’s going on here. Have you heard anything about microwave endometrial ablation, Barbara?”

Barbara Nesbitt: “Yes, I have because I’m the Editor of OBGYN.net, and they are one of our good sponsors. But I’ve never seen the equipment, I don’t know how it works, and I have to tell you that I would like to know a little of that as a woman.”

Dr. Ellis Downes: “Sure, heavy periods are a really difficult problem, and Microsulis has come up with a fantastic probe which for many, many women is going to solve their problems. It works very simply, you can see that there’s a probe here, very straightforwardly, all that the gynecologist does is to put the probe into the women’s womb and then to switch it on. Microwave energy actually comes out the tip of that probe and destroys the lining of the uterus. The great thing about it is it’s a really quick procedure. If a uterus is normal size it can be done in three minutes.”

Barbara Nesbitt: “You know what I like about it - it’s probably one of the smaller pieces of equipment that is at this conference. That looks good to me, and it works quick.”

Dr. Ellis Downes: “Yes, not only do we know that it’s safe, effective, and quick but there have been some very big studies done. More than 1,600 women worldwide have now had this treatment, and we know it to be extremely good at treating the problem of heavy periods, and it has a very low complication rate. I think any woman who wants to know more about the treatment for heavy periods should look very seriously at Microsulis microwave endometrial ablation which is a brilliant technique.”

Barbara Nesbitt: “It is.”

Dr. Ellis Downes: “What do you think?”

Barbara Nesbitt: “I think it’s a wonderful thing, and I think that having it on OBYGN.net gives women the ability to come in and find the answers. One thing - how invasive is it, do you need any anesthesia, and are you in the hospital a while?”

Dr. Ellis Downes: “You can perform it under general anesthetic but it can be performed in the office setting very easy under local as well.”

Barbara Nesbitt: “That’s even better yet.”

Dr. Ellis Downes: “So that gives women even more power.”

Barbara Nesbitt: “Yes, that’s good to know.”

Dr. Ellis Downes: “Great, that’s terrific for women to learn more about microwave endometrial ablation. Let’s now talk to one of the gynecologists who’s been involved with the development of it and get some more information. I’ve come over to the Microsulis booth really to see what’s happening here and certainly there’s an awful lot of interest in microwave endometrial ablation. It’s a great privilege for me to be able to talk to Dr. Nick Sharp, who’s had so much to do with the early development and clinical treatment of MEA. Nick, what are your impressions about what’s happening here at AAGL?”

Dr. Nick Sharp: “There certainly are a number of presentations about the microwave endometrial ablation. As you know, we’ve been using the technique in the U.K. now for a number of years, and we’re actually coming over here to tell the U.S. gynecologists how our results have been going.”

Dr. Ellis Downes: “So what sort of length of follow-up have you now got?”

Dr. Nick Sharp: “In Bath, we’ve have a five year follow-up, and I’m presenting this afternoon our five year data which is a very substantial data set of over 400 patients.”

Dr. Ellis Downes: “That’s terrific to hear - five year data because one of the problems with all these booths here is that long term follow-up data is often lacking, and five year data is very strong data. Without giving away too many secrets about your talk this afternoon, what sort of results are you getting?”

Dr. Nick Sharp: “Some of the results we’re getting are about one-third of the patients we treat don’t have any further periods, and we’re getting over 80% of them long term are having good results with reduction of menstrual flow. It doesn’t prevent every woman from ending up with a hysterectomy but it certainly stops the vast majority requiring a hysterectomy for heavy bleeding.”

Dr. Ellis Downes: “So you’re actually saying that for microwave endometrial ablation, the vast majority of women would be suitable for this sort of procedure?”

Dr. Nick Sharp: “Generally speaking – yes. If they just have heavy periods, then microwave endometrial ablation may well be the treatment option for them.”

Dr. Ellis Downes: “What about a woman who says – “I’ve got fibroids” - you know a lot of these women have traditionally ended up with a hysterectomy, must they still have a hysterectomy?”

Dr. Nick Sharp: “They need slightly more careful evaluation, fibroids can mean a hysterectomy which is still a more sensible option for a proportion of them. But with careful evaluation, we’ve treated quite a number of patients with fibroids, and they still have good outcomes.”

Dr. Ellis Downes: “I think one of the exciting things about MEA is the possibility of doing it under local anesthetic. You’ve obviously been developing those sort of protocols, what sort of problems or what sort of tips would you give doctors who want to do this procedure under a local anesthetic?”

Dr. Nick Sharp: “The first thing to say about local anesthesia is there’s a lot of patients who actually prefer that, surprisingly enough. They don’t like the post-operative headaches and wooziness that the general anesthetic gives. The vast majority do find it quite acceptable. We’ve had one or two patients where we had to give them a little sedation in addition but the important thing is to keep talking to the patient through the procedure and warn them that there may be a little discomfort at the initiation of the procedure. But it’s generally acceptable, and most women have experienced uterine pain in their lives either during their periods or during childbirth. So it’s a sensation they’re familiar with, and so long as you warn them about it, most of them - if they do get a bit of discomfort - will tolerate it. You can actually get through the procedure without needing any additional treatment other than the local.”

Dr. Ellis Downes: “That’s fantastic. We’re fighting slightly with the sound system here but the other key point that strikes me is how easy is it to learn? Have you had the opportunity to look at the success rates for people just learning it compared to an acknowledged expert like yourself? Does it take a long time to develop this skill?”

Dr. Nick Sharp: “No, that’s one of the beauties of this particular treatment. On some of the data that we’re presenting here, it shows that there’s really no learning curve. People treated by someone undertaking that first microwave ablation get the same kind of results that someone like me, who’s done a number now, get - so there is no real learning curve.”

Dr. Ellis Downes: “That’s terrific news, and I think on that wonderful point, we should say thanks very much to Nick Sharp. It’s great to have the opportunity to stop by to the Microsulis booth to see what’s new in microwave endometrial ablation. Let’s get on to the next booth. Barbara, we’ve wandered over to the Conceptus stand, and I have to say, this Conceptus stand is absolutely exciting. For me, it’s one of the stars of the show because I’m lucky to have with us someone from Conceptus, and we’re going to hear exactly what’s going on. Steve, what’s this all about?”

Steve: “Conceptus is currently clinically evaluating a device for a non-incisional permanent contraception. This device is delivered hysteroscopically. We’ve just completed our Phase II trials, we’re real excited about our results and hoping to start our Phase III trials very shortly.” 

Dr. Ellis Downes: “How does this STOP technique work?”

Steve: “It’s about a twenty minute procedure that we’re doing without general anesthesia in a majority of patients. Basically, the procedure is just like any other hysteroscopic - visualize the ostia, deliver this device via this catheter, and we leave an implant,”

Dr. Ellis Downes: “Right, so let’s just have a look at that. This is a fantastic device. Tell us how it works.”

Steve: “This is a Leuken tube catheter, it basically intubates the ostia of the fallopian tube, and we deposit a coil. Inside the coil there’s a PET fiber that elicits a tissue response that naturally occludes the fallopian tube. Basically, three months after implantation, we perform an HSG to document the results. In all of our devices that have been placed in the fallopian tubes, we have 100% occlusion - no women are pregnant. That’s what we’re excited about, and that’s why we’re here.”

Dr. Ellis Downes: “So you’ve got a 100% occlusion and no pregnancies.”

Steve: “So far to date.”

Dr. Ellis Downes: “Barbara, what do you make of that data?”

Barbara Nesbitt: “I think it’s marvelous.”

Dr. Ellis Downes: “How do you think a woman would respond to something like this for sterilization instead of conventional laparoscopic sterilization?”

Barbara Nesbitt: “I had conventional laparoscopic sterilization some years back. For some reason, I thought I was just going to go in and have a little something, wake up, and go home. It was extremely painful, it was abdominal surgery - it was major surgery. This is very exciting news to me.”

Steve: “That’s what’s most gratifying, the response we’ve had from patients. The patients that have enrolled in our study have had their friends and relatives come in and enroll them to the study. So recruitment has been great for us, and we’ve been real excited about everything.”

Barbara Nesbitt: “How long does it take to do the procedure? Do you need anesthesia? Is it something you can get up and go home afterwards?”

Steve: “Great questions. Our average procedure time is about twenty minutes - this is scope in and scope out. The majority of our patients - I’m talking about 94% - have been done with basically a conscious sedation or a paracervical block. We’ve had a Professor from Hansworth just describing to us that out of the last ten patients he did, eight of those were nothing more than a paracervical block and so…”

Barbara Nesbitt: “No general anesthesia or any of those things that are even more…?”

Steve: “Right, we’ve had some women who wanted general anesthesia. They wanted to be put to sleep during the procedure and not really feel anything but that’s not…”

Barbara Nesbitt: “As this gets more popular and more people have had it, they can say to somebody – “You don’t need to be put to sleep.”

Steve: “I think that’s up to the patient and doctor, and so that’s why we’re excited.”

Dr. Ellis Downes: “I think it’s terrific. Tell me where are the trials moving forward to?”

Steve: “Right now we’re doing trials in the United States, Australia, Belgium, and we’re going to be going worldwide shortly. We’re going to be moving from center to center as we develop our implant registry, and that’s what we’re creating. We’re going to be collecting data on these patients for the next five and ten years.”

Dr. Ellis Downes: “We should stress, of course, that this is tremendously exciting but it isn’t available in clinical practice at the moment. It’s only to be used in a research setting. Is that right?”

Steve: “It’s a investigational device, absolutely correct.”

Dr. Ellis Downes: “That is terrific. It’s been great joining the good folks here at Conceptus and their stand here at AAGL. This is a terrifically exciting product, and of course, we must wait for the research to give us the answers that we’re expecting. If all goes to hand we may have a device on the market fairly soon which really gives women a revolutionary new and effective way of sterilizing them instead of conventional laparoscopic sterilization. Great, Barbara, lets go on to the next booth and see what’s happening.” 

Barbara Nesbitt: “Thank you very much.”

Steve: “Thank you.”

Dr. Ellis Downes: “We’re having a terrific day, there’s an awful lot going on, the scientific sessions have been fantastic but we’ll take a little bit of time out to come to the exhibitors hall. We’ve come to the stand of SURx, which I think is one of the real hits of the show. These guys have brought along some fantastic, exciting, innovative technology. It’s great that David Steer from SURx is able to help us go through it in a bit more detail. David, thanks very much for spending some time with us.”

David: “Thanks very much for stopping by, we really appreciate that.”

Dr. Ellis Downes: “This is exciting and this is new, tell us briefly what’s it all about.”

David: “Basically, what we’re doing is treating female stress urinary incontinence without the use of implants like sutures or mesh. We do that be heating the tissue of the endopelvic fascia and causing that tissue to shrink which pulls up the bladder, the bladder neck, and the urethra causing a woman to have a more natural continence mechanism and regain her continence.”

Dr. Ellis Downes: “This is a revolutionary way of treating stress incontinence. How did you get this idea?”

David: “It’s actually a technology that’s been used in other areas of medicine before such as orthopedics or vascular surgery. We’re the first people to adopt it to treat stress incontinence but the whole concept of treating tissue and heating it to cause it to shrink is something that’s been well-known in other areas for quite some time.”

Dr. Ellis Downes: “I think we should stress that this is not commercially available, it’s all undergoing research trials. How many patients have you treated at the moment?”

David: “Yes, that’s right, it is currently an investigational device. We’ve treated approximately eighty patients laparoscopically. We’re also able to treat patients transvaginally, and we’ve treated about twenty patients transvaginally as well.”

Dr. Ellis Downes: “What sort of success rates are you getting?”

David: “Laparoscopically and transvaginally, we’re getting between 70%-80% success rates. We now have patients that we’ve followed up for over a year and the success rates seem to be holding right at about the 80% rate.”

Dr. Ellis Downes: “Now that’s very exciting. One of the problems with these sorts of technologies is getting the long-term follow-up but I guess a lot of people who are actually looking will be worried about the possible risk of fistula formation if you’ve got radio frequency energy. How do you address those understandable concerns?”

David: “Our energy is a lot lower than what you would normally see for bipolar electrocautery types of equipment so it’s really a self-limiting process once the collagen’s been denatured in the tissue. Applying more energy won’t cause a fistula to form or to cause the tissue to actually be cut. We can demonstrate that here a little bit later if you’d like.”

Dr. Ellis Downes: “Let’s have a look at that demonstration now. Let’s get an idea on how this actually works. The guys have got quite a nice set up here. Let’s see what’s happening. David, just talk us through exactly what we’re seeing at the moment.”

David: “Sure, this is pig fascia here that we have mounted up on a little frame. All we’re going to do is apply the bipolar energy to the pig fascia to show that the tissue actually does shrink.”

Dr. Ellis Downes: “I hope everybody can see this but what we’re actually seeing here is the fascia is actually shrinking in front of our eyes. I suppose the analogy is if this is the endopelvic fascia and you’ve got descent of a bladder neck, as it is elevated so you will elevate the bladder neck improving the patient’s symptoms. Have I got it right?”

David: “That’s exactly right, yes.”

Dr. Ellis Downes: “That’s really neat. Just show us that again so we can see how that works.” 

David: “We’ll try it on another piece of tissue here.”

Dr. Ellis Downes: “That’s amazing, really in front of our eyes we can see shrinkage along there.”

David: “Yes, and you can see how this was very lax before the treatment, and now it’s actually fairly tight and multiple passes will make it be even tighter as well.”

Dr. Ellis Downes: “I think that’s fantastic, and I think that it’s great, David, that you’ve been able show us these terrific treatments. I think that, certainly, we must obviously wait for results of long-term clinical trials, but I think this is one of the hits of the show. There’s been an awful lot of interest in this technology, and we must wait to see where it finds it’s place in the treatment for stress incontinence. David, thanks so much for taking time out to be with us, and we’ll be back very soon. Thanks very much.”

David: “Thank you.”