In this episode, I join expert urogynecologist Dr. Rebecca McCrery from Omaha, Nebraska, to discuss the innovative Revi device from Blue Wind. Dr. McCrery discloses her involvement in the clinical trials that led to FDA approval and shares her insights on the benefits and functionality of this implantable tibial nerve stimulator for treating overactive bladder. We'll cover the procedure details, patient experiences, the advantages of this device over other treatments, and the consideration of insurance and billing challenges. She underscores the importance of providing patients with multiple therapy options. She highlights the non-invasiveness and effectiveness of the Revi device.
You can find more information on Dr. McCreary and the Revi at:
https://adultpediatricuro.com/our-providers/physicians/ https://bluewindmedical.com/
Facebook: https://www.facebook.com/bluewindmedical
Instagram @bluewindmedical
Timeline
00:28 Introduction and Guest Introduction
00:49 Disclosure of Conflicts of Interest
01:59 Overview of Overactive Bladder Treatments
02:57 Introduction to the Revi Device
04:36 Implantation Procedure Details
06:48 Device Features and Patient Experience
11:18 Availability and Insurance Considerations
15:26 Final Thoughts and Conclusion
Hi there. I'm here today with Dr. Rebecca McCreary, who is an expert urogynecologist in Omaha, Nebraska. And she's here to talk to me today about the Revi device from Blue Wind. And before we get started, she just wanted to mention a couple of disclosures that she has. So do you want to go ahead and start there?
Good morning.
Thank you. I do want to disclose that I have participated in the blue wind clinical trial that resulted in FDA approval of the device. And I'm presently recruiting patients for a post FDA approval study. And then I have done some consulting work with the company in the past.
And I mean, you have done similar work with other companies in the past, correct?
It's not just exclusive to this company.
That's correct. I've participated in a number of clinical trials for a variety of overactive bladder devices and other urogynecology therapies, I guess, and consulted for a number of different companies, including other implantable tibial nerve stimulators.
Yeah. And, and I would trust you to be as objective about this data as possible. I mean, I, I think it's always important to disclose all of our biases. We have biases, but I, I think you can speak to the device without overstating anything. Is that fair?
Yeah, I think that's fair. And a lot of it doesn't come down to particular numbers or anything, but rather introducing just another concept that we have to treat overactive bladder and just helping spread.
information and make it available to patients.
Yeah. I, you know, when it comes to the numbers, I always feel like our treatments for overactive bladder, everything works about the same. And it's really just finding the treatment for that particular patient that suits them the best.
I would agree. You know, like it's, we've got a number of different options now.
And I never know exactly which option is going to work for a particular patient and it's a little bit trial and error. And then what appeals to a patient.
Right. I agree. But all the data, I mean, it seems like it's always somewhere between 60 and 80% success rates, right? Sometimes a little bit better, but right in that range.
Okay. So this device is for overactive bladder. So frequency, urgency, needing to run to the bathroom, not being able to get there on time. And it's a tibial nerve stimulator. So your tibial nerve runs along your ankle and there are different ways that we can stimulate it. So you can stimulate it.
transcutaneously with patches. So through the skin percutaneously with needles through the skin. And then there are implantable devices. And do you want to talk about what type of device this is?
Yeah. So this is an implantable device. We implanted using local anesthesia, local numbing medicine. And it's performed as an outpatient procedure.
And the nice thing is, The device is a therapy that would be a long term treatment option for patients. And I think that really aligns nicely with overactive bladder being a chronic problem that really deserves a chronic therapy. So it's nice that a patient doesn't have to be in my office all of the time to receive the treatment, which would be the current model for some of the percutaneous therapies on the market.
And so it really moves the needle in, in introducing a therapy that patients can do a little bit more on their own terms.
Yeah, I, I agree with that. I, I think it's important that we support people, but I think most people would prefer to be, you know, away from the office and managing these things on their own time.
So when you're implanting it, are you doing it in your office or are you doing it in a surgery center?
I'm doing it in a surgery center. I certainly could see how it could safely be done in the office. It's just that's the best setup we've had. From just I guess the technical aspects and having the right support staff that knows the importance of sterile technique and things like that.
But I could certainly see how it could be implemented in an office safely in the future.
How long does it take to implant it?
Maybe 20, 30 minutes, you know, some of it is just depending upon you know, what kind of response the patient's getting. And I really think it's important to take the time during the procedure to make sure the placement is optimized.
And so. You know, one procedure might take a little longer than another. And you know, but if you don't get the placement, right, you know, it's hard to expect the therapy to work. Yeah.
When you talk about placement, how are you checking that in the office or in the procedure?
Yeah. Ideally we see the nerve bundle.
And so we are laying the device right over the Actual tibial nerve area. But then we're asking patients where they feel the stimulation when we turn the device on or activate it and making sure that they're getting the appropriate sensation at the right time. Reasonable levels. Okay. So the objective information, you know, like we're seeing it and then having the patient confirm.
So patients are awake while you're doing this and you're asking them where they feel the stimulation and making sure that when you turn the stimulation on, you don't have to turn it on super high. Is that right? Okay. Yep. And then what makes this device different than the other implantable tibial stimulators?
One nice feature of this device is that there aren't any batteries that are part of the implant. And so all of the batteries or things that would wear out over time are in the low band that the patient wears on their ankle to activate the device. So you're not having to go through another surgery to change out a battery, you know, when it wears down.
So it's one and done. And I think that's important because even if the battery lasts for a long time, I mean, you're, at some point you're going to be back replacing that battery and, and that's a, that's a surgery and that's a lot for people to go through how, so when they wear this external stimulator, how often do you have to wear it?
So in the clinical trial that we. Participated in and are currently enrolling patients for patients use the device for 30 to 60 minutes a day. Now, I can certainly see, you know, like, if a patient has the device implanted outside of the setting of a clinical trial, I could see them using it a little bit.
differently to adjust to their, their situation. But those are the parameters we're using for the clinical trial.
Yeah. So the current recommendation is to do it every day. Yes. Do, do they know? So if it were me, I would want to charge it the least amount possible. Right. I mean, I would want to do it as infrequently as possible.
Do they know that that's the, the minimum amount that you need to get the results?
You know, I think every patient's a little bit different and the way the FDA wants these trials designed or wants to approve things is with specific parameters. Yeah. And so I imagine for one patient it's different than another and and it may change for individual patients over time as overactive bladder kind of waxes and wanes just with how it behaves.
Well, and it just seems to me over time we're learning with the neurostimulation that you, you can stimulate it less than we initially thought. Especially with sacral neurostimulation, right? It doesn't have to be continuous or as frequent. So, you know, it'll be interesting to see over time if that recommendation is less.
Do you have any idea what patients think about that? Do they find that to be a burden or are they just happy to be doing it at home?
You know, I think patients are happy doing it at home. And I think patients, I think patients really are looking for. results. And so if somebody is getting efficacy, I think they're willing to do what it takes to achieve that goal.
And you know, I think in, in reality, you know, patients are gonna miss a day here or there and might make up for it. You know, on another day, but I do think there's something to be said about patients being kind of aware that their actions do affect their bladder and their, you know, the results they're getting.
Yeah. So when they are wearing the battery and they're stimulating the device and the battery is on It's on what kind of a a device that you, yeah, that you strap around your ankle. Can you do things while you're stimulating it? I mean, could you be doing the dishes, working around the house?
Yes.
So it just needs to make to continually interact with the stimulator or the device. And so it maybe wouldn't make sense to be doing a vigorous walk outside, but certainly, you know, household things, it's it's got a Velcro band to it. So it stays in place and One can be up moving around.
Okay.
So I, I feel like I should know this, but I don't actually know this. Is it commercially available at this point in time or is it still just available via trial?
It is commercially available at this time. It's waiting kind of a final determination for a CPT code. And so you know, it's just trying to figure out that insurance piece at this point.
Okay. So the device is available, but the whole billing part is lagging, which is, you know, pretty common with new devices, but definitely impacts how quickly physicians can start doing them. Is it available all across the country or just in certain parts? Because, you know, things come to Oregon later than they come to other places.
Well, Nebraska usually isn't the first place for things either. So I can relate to there with, with that. But I think it's definitely available at sites that were involved with some of the clinical trial work. And then like my site. Is currently enrolling patients in kind of a subsequent trial.
And so the, the implants we're doing right now, we're, we're running through that, that trial, just because we're kind of waiting to see where the coding ends up.
So if someone is interested in this device do they have a physician finder on their website?
You know, I haven't, I haven't looked to see if they have that, but I would guess that they will in the near future if it is not already out there.
Yeah. Do you know what the website is? Is it Blue Wind?
Blue Wind is the name of the company and Rebi is the name of the device. I want to say Blue Wind Medical is Yeah, the website. And then I'm sure they have contact information there. So if someone is interested, they could get more information on the website.
In general, have the patients in whom you've implanted this device, have they been happy with it?
I feel like we've had a lot of really happy patients with it. I think there's a lot of patients that are looking for a non medication therapy that, works with their lifestyle. Yeah. You know, the, the percutaneous tibial nerve stimulation just doesn't work.
For so many patients because they don't, you know, live close to the office.
Yeah. Right. I mean, when you do that stimulation, you have to come into the office once a week for 12 weeks, and then you have to come in for maintenance and you're right. That is a very difficult thing for a lot of patients to do.
I mean, even if you live close. It's very time consuming. And I, you know, I think a lot of patients feel the same way about Botox as well. I mean, you're frequently getting those injections every six to nine months, but six to nine months comes around pretty quickly. So having something you can do at home, even if it's Daily, I think is very attractive to a lot of people.
And then my own bias is that I think sometimes when we're talking about nerve stimulation, I, I think, you know, sometimes the sacral nerve stimulation in the back feels really invasive to people, but somehow the ankle doesn't.
Yeah. And there's certain people that just don't want something done in their back for whatever reason.
And so it's really nice to have. another option to stimulate. And I think the other thing is, if this doesn't get somebody the results that they're looking for, sacral neuromodulation is still an option. Botox is still an option, right? Medications still an option,
right? I mean, you can always do multiple things.
Yeah. And I think the more options we have for people the better, right? Because different people want different things. Is there anything else that you want to say about this particular device?
I was really excited when I saw that the way it got approved was that patients didn't necessarily need to fail medications in order to be a candidate for this device in the FDA labeling of it.
Now we'll see what insurance companies require, you know, for them to approve it, but I. I really don't understand why medications always have to be tried first before we move onto other therapies. And I think the fact that the FDA did label it in such a manner really speaks to them seeing the safety of the device.
And yeah,
and, and I don't know that medications are always. safer than other therapies. So
no, I definitely, I mean, I agree with that. I worry about the systemic effects of medication, right? I mean, the side effects are frequently intolerable, but then also you're impacting the rest of your body in so many different ways.
And there are lots of people that aren't willing to take that risk or can't take that risk. I think we think of medications as being easier, but I think these. You know, therapies that target a very specific area or a very specific nerve you know, work in such a limited way in the body and they just impact that nerve.
And I think in a lot of ways that's a lot safer. So I agree with you. I think that'll be a really interesting shift if we can offer medications to patients, but not necessarily have to try them on everybody first, right? And have people fail them because some people are forced to take medications and before they can do anything else.
And, you know, that's not, I mean, that's not really the way that I want to practice medicine.
Well, especially when you. Have potential risks of cognitive decline. I mean, that just doesn't sound real appealing to sign up for or wanted to ingest, you know, like whether I've got, you know, memory changes as part of my family history or not.
Yeah, it's, it's hard to pick memory changes and, and dryness, right? But I mean, right.
Yes.
Well, I want to thank you for your time and your expertise. There aren't a lot of people that are doing these implants yet. And so I really appreciate your taking the time to talk to me about it and your experience.
Well
thank you.
Always a pleasure.
