Baanya said:
"Vieve approved by the Australian TGA for use in Australia
Vieve approved by the US FDA for use In the US"
Baanya, while your above claims are technically true, there is more to the story.
I was interested to find out how this product, which delivers Radio Frequency inside the vagina to improve the structural integrity by increasing collagen production, would help with Urinary Incontinence which is caused by many different things but one prominent cause is lax pelvic floor muscles. I went directly to the Vevive website.
Quote from article: “Our device was one of the few brands not mentioned by the FDA because it’s completely safe”, said Viveve device consultant Judith Booker. “Our system uses a completely different type of laser, so there’s no risk of burning or injury.”
This is a very cleverly worded sentence which doesn't actually reveal the full truth. Perhaps it is more accurate to say that their device was not mentioned by the FDA because (according to their own website) their device does not have regulatory approval for the indications made in the linked article in the US, and so why would the FDA mention it. It might be safer to use in your vagina than a laser, but you still can't use it for UI treatment in the US. And you can't use it for UI in Australia either.
Quote from the Viveve Website:
"In the United States, Taiwan and Thailand and the Viveve System is cleared for general surgical procedures for electrocoagulation and hemostasis.
Viveve has received regulatory approval in many additional countries throughout the world and is available through physician import license in Japan.
Country-specific approved indications include:
• In Argentina the Viveve System is approved for the treatment of urinary incontinence
• In Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Hong Kong, Japan, Malaysia, Panama, Philippines, Singapore and the UAE the Viveve System is approved for the treatment of the vaginal introitus, after vaginal childbirth, to improve sexual function.
• In the EU, Iceland, Korea, Lebanon, Liechtenstein, Norway, Switzerland and Turkey the Viveve System is approved for the treatment of vaginal laxity."
Despite what the linked article appears to say, it seems that this product only has regulatory approval for treatment of Urinary Incontinence in Argentina.
Furthermore, the Vevive website shows that they are currently in the process of recruiting patients for clinical trials for the UI indication.
It's all there on their website. Although it looks like there is quite a future for this device in improving vaginal laxity and restoring sensation in the vagina after childbirth, it appears that it is a fair way off being able to claim that it can improve UI. And I suppose that even if some UI cases are resolved by this treatment, it is treating a different underlying cause than the PeriCoach and so is not a genuine competitor to our product.
The linked article in the first post, appears to be nothing much more than cleverly worded advertising. Read it again. Note the doctor quote in the middle of the article about the evidence of being able to cure UI being scanty. That's called covering your a... Note that that statement is surrounded before and after by anecdotal claims so that you forget that you just read that there is no scientific evidence to support it's use for UI....
I do hope though, for the sake of women all over the world, that when they complete their clinical trial it results in some form of positive outcomes for women suffering UI. Although the $2500 price tag would put this treatment out of reach of most suffers i would suggest.
ALT Price at posting:
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