I’ve been trying to do due diligence on this device since the company contacted me about a month ago. They have not made this easy and here’s why I’m concerned.
What is it? This is a new way to deliver radiofrequency (RF) into the dermis with possibly less discomfort, less downtime and more reliable results. It’s a patented RF cannula inserted into the skin and then moved under the skin in a fanning motion to create the heat that then tightens the skin.
What’s not to like? Like many marketing campaigns, Reveal (the company who owns this) is not making it easy to figure out if these results are real. The technology is patented by an Italian company and then licensed by Reveal in the U.S. and being sold as Attiva.
Concerns about the company Reveal, owner of Attiva:
- What’s unusual is that Reveal is solely a marketing company and not a device company. Usually a device company will buy or license a technology from a European company and then vet it themselves. They will publish about it, get FDA approval, and have several doctors present this at conferences. None of this has happened yet.
- One U.S. plastic surgeon in Denver has developed the protocols for use and published before and afters. It’s easy to see how this could be a conflict. He is a key member of the company and has a significant financial stake it seems.
- Reveal was started by Cynosure’s marketing group, who left the company together to start Reveal. There is a lawsuit against Reveal by Cynosure. There hasn’t been a good explanation of the risks of this suit for the company.
Concerns about the data:
- First of all, there is very little data. This device was supposedly launched in Europe, but didn’t launch well. Why not?
- Is there data from the EU that we’re not seeing?
- Why is all the data in the U.S. from one plastic surgeon who has a significant financial interest in Reveal?
- Why is the data not published?
- Are the before and afters, just the top 10% of results? What percent of patients are getting these excellent results. The response from our reps was just that “patient satisfaction rate has been off the charts”. Kybella had excellent patient satisfaction ratings until it wasn’t free and was being used in more clinics.
Potential for complications:
- Whenever a great deal of heat needed to tighten skin is used, there is a potential for complications like fat divots, uneven results, no results, etc. In my opinion, possible complications haven’t been addressed adequately by the company.
- We’d all like to know more about possible burns, divots, uneven results, color problems.
After the experience with Ellacor, where complications were very much minimized by the company, we all need to be skeptical, I think.
If anyone knows more, I would love it if you’d communicate with us by calling our clinic at (206) 939-6633 and leaving a message or going on our website and contacting us that way.
I hope this helps, and I would love it if this was real…..but is it?
Brandith Irwin, MD
Concierge Dermatology & Laser, Seattle
Founder of SkinTour
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