Adiana

Discussion in 'Conceptus' started by Anonymous, Feb 23, 2007 at 4:59 PM.

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  1. Anonymous

    Anonymous Guest

    I can't beleive that I am doing this (and will certainly be slammed), but here goes. I am an OB that has lurked on this site for some time. It is REALLY FUNNY, almost voyeuristic.

    I cannot comment on the business practices of conceptus, but the clinical stuff...

    ...as someone that does about 3 to 5 Essures/mo in the office, IMHO it is a nice product. Adiana is all hype. My protocol is 10 mg Valium PO prior to coming to the office, Torodol IM and then 10 cc of 1% lido intracervical. It really is a pain free procedure. The valium is overkill, but what the heck, everone deserves a good buzz now and then.

    This is from a OBG magazine about Adiana.

    As of Sept. 30, 2005, the Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women (EASE) study had enrolled 770 women at 16 sites. Almost half (47%) were aged 28-33 years. A total of 655 patients were taken for hysteroscopy, and 10 were excluded for hysteroscopic findings. The remaining 115 patients either withdrew from the study or were excluded from the study protocol.

    Treatment was attempted in 645 patients and bilateral placement was achieved in 614 (95%).

    This placement rate is comparable with that attained by Essure in its clinical trials, he said. Lateral location of the ostia is the most common reason for failure of placement of hysteroscopic sterilization devices.

    The average procedure time from insertion to removal of the hysteroscope was 12 minutes. Local and oral anesthesia was used in 35% of patients, local anesthesia plus intravenous sedation in 48%, and local plus intravenous analgesia in 17%. Nine patients were lost to follow-up or are awaiting 3-month hysterosalpingogram (HSG).

    Notice that that local plus IV sedation rate was 50%. No one is going to use IV sedation in the office. That is the problem with Novasure getting into the office. It is just way too painful.

    Other tidbits...I see my rep maybe once every 6 to 9 months. I am a trainer and have trained exactly 1 doctor (my friend and the never paid me). I think that there is very little selling going on (at least in my area of NE Ohio).

    The reimbursement is fine in OH and that includes welfare. Remember, we only get $280 for a LSC BTL in the OR. This procedure saves me $$ because it saves me TIME. Time that I can be at home with my family or in the office seeing patients. It is a total waste of time to schedule 3 BTL on a Friday afternoon, blow the whole afternoon for $600.

    That being said..many people still do it...just not me
     

  2. Anonymous

    Anonymous Guest

    Oh my sham a dong ding dong better get his people on the ball! I find it interesting that this physician doesn't even see his rep and the corporate end of treating our users and reference sites as partners is once again displayed by this posting.

    Essure is a wonderful product with a horrible leadership problem. Doc you watch how the Novasure rep treats you and see if perhaps there isn't an opening for at least a trial.

    I have personally seen Novasure done in the office without iv sedation and I am sorry to disagree with you--I'm not sure if you yourself have done it in the office setting--and it was in this reps opinion more tolerable than a balloon. Here is the spin Adiana will weave---you can follow this with any procedure of your choice without worry doc. I.E. a resection, a d &C and yes an ablation procedure of your choice or the choice of many well educated women--NOVASURE. Every doctor owes it to himself and his patient to at least familiarize himself with every modality---

    Oh yea Adiana is set for roll out---I believe my Cytyc colleagues will go to training at the end of January with a launch anticipated in February.

    Now here's a thought---what if-just maybe--Cytyc gets a combination procedure approved---the pregnancy question is tossed out of the window.

    It is truly a shame to see such a great product miss it's window of opportunity.
     
  3. Anonymous

    Anonymous Guest

    To above Poster "I bet Adiana won't be approved this time next year": Adiana was pretty much cleared/approved by the FDA Dec. 13, 2007

    Looks like you lost the bet!
     
  4. Anonymous

    Anonymous Guest

    Heard Hologic got a letter from the FDA requesting they follow patients out another 12 months before they will consider an approval of Adiana. Approval (if it happens) will be delayed for quite a while if this is true.

    Recap of the Adiana Data presented at the FDA panel meeting:
    * 10 pregnancies to date
    * 2 ectopic
    * One pregnancy in the few patients that have reached year 4

    Heard thru the grapevine there is an additional pregnancy for a total of 11. Doesn't look too good.
     
  5. Anonymous

    Anonymous Guest

    If you knew anything about the FDA you would know this is done for most all medical devices. This was done for Essure as well.

    Recap

    99% of the women did not get pregnant
    Essure has more than 30 or more Preg a year

    FYI: There were actually 11 preg and not 10
     
  6. Anonymous

    Anonymous Guest

    The Adiana Clinical Trial which was conducted by experts had 10 pregnanies.
    The one at 4 yrs being most concering- can you say fistula formation.
    And patient reliance after proper placement is 1 in 20

    The Essure Clinical Trial had none and reliance after proper placement is 100%.

    There is a ten fold increase in pregnancy with adiana over essure.

    In commerical use essure preg rate is 1 in 1000. Adiana preg rate is already 1 in 50- and it is not even out in commercial use. Sit back and watch those rates skyrocket.

    Who was the wonder kid who decided not to make Adiana radio-opaque? Great idea! Tubal occlusion or spasm; hmm can't be sure. Each HSG film was read by two independent radiologists, even then in some 40 or so films the radiologists could not come to the same conclusion. Thats roughly 8% of patients- again these are HSG's read by experts.
     
  7. Anonymous

    Anonymous Guest

    The above poster is pretty accurate....I could poke some holes.......now lets give fair balance

    Adiana had a placement rate that was around 95% while Essure was around 85% (One could easily convince a doc that those 15% of women who did not receive Essure will consider there procedure a failure)

    The average age of the Adiana patient was significantly younger than those in Essure trials (this will be an argument that Novasure reps make)

    Adiana to date has not had any allergic reactions to their product like Essure has (Fact, and this goes under reported)

    The Ablation choice after TL will play a major role in which device the doc chooses (hard to argue that Novasure is not the best device when they have almost 80% of market)

    I would agree that clinically Essure is a better product but with Novasure having almost 80% national market share it would make sense to use a product that has 98.9% Efficacy at the year one mark. You can try and put a spin but it has about 99% efficacy which is still dam good
     
  8. Anonymous

    Anonymous Guest

    Just because Novasure leads in market share does not mean it is the best choice. If you go by the published data, HTA has the best outcomes. As a physician I would not use Adiana by default just because I could ablate the patient with the same companies device. I don't buy it. HTA has better amenorrhea and overall success rates. I have done Novasure and HTA in the OR and office and HTA has been far more tolerable even though it takes longer.
     
  9. Anonymous

    Anonymous Guest

    It seems to be the best choice for about 8 out of 10 physicians. If you go IFU to IFU what you said is true about amenorrhea rates (they both are in the mid 30%). However, there are studies that show Novasure has up to 70% amenorrhea. When you compare the the whole wall of published data Novasure wins hands down.
     
  10. Anonymous

    Anonymous Guest

    I disagree. What wall of data are you talking about that shows Novasure wins? Hands down? The data I have seen shows amenorrhea rates in the high 40's to mid 50's at 3 years, with HTA being slightly higher. Have never seen 70% in any study.
     
  11. Anonymous

    Anonymous Guest

    I don’t know much about GYN (been in vascular sales 5 years). If a device has 70 or 80% market share it must have a huge advantage over the competition. Unless it was the first to market and surgeons just stayed with it.
     
  12. Anonymous

    Anonymous Guest

    Now you have seen amenorrhea rates 70% (68% to be exact) in a study.....Congrats!


    Eight Studies Evaluating Cytyc's Novasure(R) System Presented at AAGL Meeting

    MARLBOROUGH, Mass.--(HSMN NewsFeed)--Cytyc Corporation (Nasdaq: CYTC ) today announced that a total of eight studies evaluating performance of the NovaSure® System for endometrial ablation were presented at the 33rd Annual Meeting of the American Association of Gynecologic Laparoscopists (AAGL) in Las Vegas. The studies covered a range of performance characteristics and patient populations. The studies included two evaluating the use of the NovaSure System in an in-office setting, and one presenting five-year follow-up data on the efficacy of the NovaSure System for the treatment of abnormal uterine bleeding using second generation endometrial ablation.

    David Kreuze, M.D., presented a study assessing the ability of performing the NovaSure Endometrial Ablation in-office under local anesthesia. The study included 30 patients with refractory menorrhagia. All patients were treated with NovaSure Endometrial Ablation with no endometrial pre-treatment of any kind. Patients were instructed to take a mild tranquilizer and an analgesic prior to arriving at the office. At the office a local anesthetic (para-cervical block) was administered prior to the procedure. The author reported that 29 of the 30 patients were treated successfully and 87 percent reported minimal or moderate discomfort. All treated patients were released within 15 minutes of procedure completion.

    Robert Southwick, M.D., and Amy VanEss, R.N., presented a similar study, which assessed the safety, tolerability, and efficacy of NovaSure Endometrial Ablation performed in-office with minimal anesthesia. The prospective study included 78 women with severe menorrhagia secondary to dysfunctional uterine bleeding (DUB). All patients underwent pre-procedure endometrial biopsy and hysteroscopy. The patients did not receive any drug or mechanical pre-treatment to thin the endometrium prior to the procedure. Patients were advised to take a mild anti-anxiety and an analgesic orally before arrival and were given a local anesthetic at the office prior to the ablation. NovaSure Endometrial Ablation was successfully performed in-office with local anesthetic on 94 percent of patients (73/78). Three patients were not eligible for ablation and the NovaSure procedure was successfully performed on two others in the operating room. Results for the 73 patients showed average pain scores similar to pain experienced during menses. The patients treated with NovaSure Endometrial Ablation had a mean satisfaction score of 4.79 on a scale where one is dissatisfied and five is extremely satisfied and 72 of 73 patients said they would recommend the procedure to a friend.

    A study by Bongers et al., from Maxima Medical Centre, in Veldhoven, The Netherlands, presented five-year follow-up data comparing the NovaSure System and ThermaChoice® balloon ablation for the treatment of pre-menopausal women with menorrhagia. The study included 126 patients randomized at a ratio of two to one, NovaSure System versus ThermaChoice. Five-year follow-up data was available for 80 percent of the NovaSure System arm and 72 percent of the ThermaChoice arm. Results showed that at five years post-treatment, hysterectomy was avoided in 91 percent of the patients treated with the NovaSure Endometrial Abalation System and 89 percent of patients treated with ThermaChoice. Amenorrhea rates were 68 percent in the NovaSure arm and 36 percent in the ThermaChoice balloon arm. The authors concluded that the NovaSure System is an effective and safe second-generation device, and yielded better amenorrhea and patient satisfaction rates when compared to ThermaChoice.

    "The studies presented at this meeting clearly demonstrate that use of the NovaSure Endometrial Ablation System in an office setting under local anesthesia is a viable alternative for many patients and their physicians," said Ellen Sheets, M.D., Cytyc's chief medical officer. "In addition, the five-year follow-up data presented at this meeting suggests that NovaSure provides a greater long term amenorrhea rate as compared to the balloon technology and validates the efficacy of NovaSure technology in avoiding costly and invasive hysterectomies for the treatment of menorrhagia."

    Cytyc Corporation is a leading provider of best-in-class medical technology that enables physicians and laboratories to improve patients' lives throughout the world. Cytyc provides diagnostic and minimally invasive surgical products targeting cancer and women's health. The ThinPrep® System is the most widely used method for cervical cancer screening in the United States. The ThinPrep System consists of the ThinPrep® 2000 Processor, ThinPrep®3000 Processor, ThinPrep® Imaging System, and related reagents, filters, and other supplies. The ThinPrep System also provides the platform from which the Company launched its expansion into breast cancer risk assessment with the FirstCyte® Breast Test. The NovaSure® Impedance Controlled Endometrial Ablation System, or the NovaSure® System, is an innovative endometrial ablation device to treat menorrhagia, or excessive menstrual bleeding. The MammoSite® Radiation Therapy System is a single-use device for the treatment of breast cancer that positions radiation sources directly into the post-lumpectomy site to optimize radiation treatment delivery while minimizing damage to healthy tissue. The GliaSite® Radiation Therapy System is for the treatment of malignant brain tumors.

    Cytyc is traded on The Nasdaq Stock Market under the symbol CYTC. Cytyc, ThinPrep, FirstCyte, NovaSure, MammoSite, and GliaSite are registered trademarks of Cytyc Corporation. ThermaChoice is a registered trademark of Johnson & Johnson Corporation.
     
  13. Anonymous

    Anonymous Guest

    looks like somebody needs to sharpen the "old" clinical saw
     
  14. Anonymous

    Anonymous Guest

    The data I have seen is different- 53% amenorrhea for HTA at 3 years and 44% for Novasure. 94% success for HTA vs. 87% for Novasure. Not sure why the data is so drasitcally different and would be interested to know the answer. Also, I have looked on the MAUDE database and HTA appears to be much safer overall, with far less serious injuries. Hard to argue patient safety.
     
  15. Anonymous

    Anonymous Guest

    Wow.....are you that brainwashed?.....It’s obvious that you feel that HTA is the best thing since sliced bread (that’s fine). The above referenced article is 1 of 3 that I know of that show Novasure has an amenorrhea rate of around 70% (remember the whole wall of evidence). The fact that you referenced the MAUDE database to compare the safety of Novasure vs. HTA shows that you are a true idiot. For every 100 cases done with Novasure there are only about 10 done using HTA. So, of course there would be a discrepancy in adverse events. Everyone knows that the Maude database goes hugely under reported. On this same subject Thermachoice had a death were a patient died because of an allergic reaction to anesthesia prior to use of the device. This went into the IFU and Maude database for Thermachoice and the device was never even opened. I’ll put this one to rest by using an above quote that is relevant, “If a device has 70 or 80% market share it must have a huge advantage over the competition. Unless it was the first to market and surgeons just stayed with it.” The proof is in the pudding. The GYN’s have spoken and it’s obvious that Novasure is the best GEA for at least 8 out 10 cases. Hard to argue that surgeons would use a device 8 out 10 times that did not have great safety results when other viable results are available!
     
  16. Anonymous

    Anonymous Guest

    Brainwashed? I don't think so. Idiot? I'll put my intellect up against yours anytime.
    Yes, the MAUDE database is underreported but that doesn't change the fact there are a significant amount of bowel injuries as a result of Novasure. Based on underreporting there must be more. I will take the possibility of a vaginal burn to a bowel injury any time. I'll tell you what, you start paying my malpractice insurance, I'll start using your product.
    Regarding the post about “If a device has 70 or 80% market share it must have a huge advantage over the competition. Unless it was the first to market and surgeons just stayed with it.” The advantage is speed, and yes, many physicians prefer that. The other thing is a lot of doctors were trained on Novasure and stayed with it after residency because of comfort level. The big advantage of HTA is I can see during the entire procedure and I can treat more patients and different patients (fibroids, large cavities, septate...) because the saline conforms and treats the entire cavity.
    Again, I have done both but clearly prefer HTA just like you tout Novasure. We all have our reasons for using what we use.

    By the way, this string started because of an Adiana post and I still contend that a physician should not blindly use a product because they use the same companies product for other purposes. I use Essure and it is a great product. I would not switch just because another company that I use came out with something. It has to be better and so far everything I have seen or been told about Adiana does not command any reason to switch.
     
  17. Anonymous

    Anonymous Guest

    what an f'ing joke. any dr that posts on rep boards should continue to use inferior products. fyi, i wouldn't wanna touch your malpractice.
     
  18. Anonymous

    Anonymous Guest

    You are lame. If the doctor agreed with your opinion, you would be psyched they were talking it up. This one doesn't so you have to try to put them down. Give me a break.
    Since when are doctors not allowed to read/post on rep boards.
    Don't we deal with them everyday? Are we too cool for them or vice versa?
     
  19. Anonymous

    Anonymous Guest

    If I was an Essure rep, I would fire up the resume. Phase III data is strong and Novasure dominates the market with over 70% share. Docs are salivating at when it will be launched. Furthermore, it can be used in conjunction with Novasure so the balloon reps should get worried about their slim market share getting smaller. Docs prefer Novasure over Thermachoice so when Adiana comes, Essure and THC are in trouble. Essure has yet to deliver what they had hoped.
     
  20. Anonymous

    Anonymous Guest

    Increase in Sales Force?

    Just heard from the Florida reps that NovaSure is hiring 75-100 junior reps for the upcoming Adiana launch. Can anybody verify this? I didn't think the product had been approved?