Gregory Levitin, MD, Otolaryngologist/Head and Neck Surgery, Director, Vascular Birthmarks and Malformations at the New York Eye and Ear Infirmary of Mount Sinai talks about a new noninvasive procedure involving cryotherapy to help patients with their congestion, runny nose, and breathing issues.
Interview conducted by Ivanhoe Broadcast News in May 2019.
Talk to me a little bit about ClariFix. What is it designed to do?
LEVITIN: Well, ClariFix is a very interesting procedure. It takes an old technology – cryotherapy – but applies it in a nonsurgical way. So instead of having to cut tissue, we’re actually just applying a topical freezing to a nerve in the back of the nose. Now, this nerve is a very important nerve. It controls the feelings of congestion, of post-nasal drip, of a runny nose. And so these are pretty much the common symptoms that a lot of people have when the weather changes, the temperature changes or the pollen counts change. Now, in the past, we’ve always looked at this as a – how do we treat this? Either with medications all the time, whether it be nasal sprays or tablets, whether it be surgery where we’re trying to shrink tissue or remove tissue. But now, for the first time, we have a nonsurgical remedy where we’re not even entering the tissue, we’re just applying cryotherapy or freezing to the back of the nose. And within 30 days, we’re seeing a reduction in 50% or more in nearly every patient with less congestion, less runny nose, breathing better, sleeping better.
How this is done?
LEVITIN: The ClariFix device is done under local anesthesia. So, to make someone comfortable, we apply a topical anesthesia, kind of like going to a dentist, wait about 10 or 15 minutes. And then we apply the device, which is, again, freezing the nerve in the back of the nose. This is done in about 15 to 20 minutes in an office setting. People literally walk in and they walk out. It’s been a real game changer for a lot of patients because they’ve not been able to find a treatment that can give them long-lasting effects without having to sacrifice time away from work or having to take on the burden of surgery or any other invasive procedure.
How long does it take to actually treat that nerve in the back of the nose?
LEVITIN: ClariFix is a surprisingly simple device. So, the actual device applies for 30 seconds freezing to the back of the nose on the left and the right side. But to make patients comfortable in the office setting, we have to apply anaesthesia. So, we do a combination of topical anesthesia and local injections, kind of like a dentist, to make people comfortable. And it takes about 15 minutes to make them numb, but literally less than a minute and we’ve made a big difference.
Any other side effects? Any pain or swelling anyplace else?
LEVITIN: So for the ClariFix device, the anasthesia usually is sufficient for most patients. Occasionally someone may have a headache, basically like a brain freeze, for about 15-20 minutes afterwards. But once it goes away, there’s essentially no other pain. The first few days may be a little extra runny nose or a little extra congestion, as if you caught a cold, but they’re not sick. But by the end of the first week, people are already healing. By the end of 30 days, the net effect is pretty much taken hold and most people are seeing a significant reduction in their symptoms.
How often does this have to be redone? Is this a once-a-season, or once you do it one time, are you good to go?
LEVITIN: For the ClariFix device, we like to call it a one-and-done procedure. If you do it one time, it should create a sufficient scar to reduce the activity of the nerve that innervates the back of the nose. This should translate to less congestion, less drip, better breathing pretty much within 30 days.
Who’s this good for? Who’s the ideal patient for this?
LEVITIN: The typical patient is someone who has year-round symptoms. If you only have symptoms during allergy season for a couple of weeks, take a couple of medications – take some medicine for a couple of weeks, and you’ll be fine. But so many patients have year-round symptoms, year-round congestion, year-round drippy nose, year-round excess secretions. And these are the people who are really suffering a lot in their quality of life. So for the ClariFix device we’re looking for patients who have tried medication in the past but failed, tried other remedies but did not work. And these are patients who are not sick but their quality of life has been affected and can make a really big difference in how they feel.
Is there a temperature? Is there a threshold? What essentially are you freezing to be able to affect the nerve?
LEVITIN: Essentially with cryotherapy, we are applying a cold temperature, essentially a subzero freezing temperature, for a consistent amount of time to create a controlled scar. And that controlled scar limits the activity of the nerve through that pathway, and therefore we get a reduction in symptoms.
Is it FDA approved and how long have you guys been using it here?
LEVITIN: This was FDA approved back almost two years ago, and we’ve been using it. Actively, we were one of the first centers that began using this. But now we’ve had easily over 150 patients treated, and the response has been overwhelmingly positive. People can’t believe how easy it is. That’s often the first thing they say is “that’s it?” In less than a minute, we can really make a big difference for these patients.
Is it covered by insurance?
LEVITIN: Absolutely. This is a covered-by-insurance procedure.
LEVITIN: ClariFix is a new procedure. But the good news is that this is covered by most insurances. And we’ve been able to get almost every patient that’s come through the office covered by insurance when it’s appropriate for those patients.
Can you tell me a little bit about David? He’s the patient that’s coming out.
LEVITIN: So David’s a great example of a patient who basically has had a chronic stuffy nose. This is someone who’s never breathed normally, has perhaps gotten worse during allergy season. And when David came in, he had already tried many of the types of medical treatments we’ve had before. David had already tried nasal sprays, he had already tried the oral antihistamines, and tried the saline rinses. It wasn’t that he was so sick, but he was actually quite miserable from his quality of life and his quality of breathing. So now that David’s several weeks out from his procedure, when you ask David how he’s feeling, he has to think about it. Like, he really forgot what he used to feel. And now his symptoms are the kind of things where he doesn’t think about how stuffy his nose is. He goes to bed breathing well. He doesn’t wake up stuffy or having to blow out mucus from the back of his nose. So many of the little things that affect your quality life change. And I just like to say it’s like a puddle that evaporates – eventually it just goes away.
Is there anything I didn’t ask you that you would want people to know?
LEVITIN: I would want people to know that this is safe and effective. It’s been proven for several years in treatment now. And I think for the right patient this can make a big difference in their quality of life.
Most people who would come in, they said other doctors, or doctors who don’t offer this, they say you need surgery.
LEVITIN: Yeah. Exactly.
So is this a step above or in between surgery and medication?
LEVITIN: The way to look at cryotherapy or ClariFix procedure is as a nonsurgical alternative for the same type of symptoms that we used to treat with surgery or medications. So we’re really looking at a different way of treating patients in the traditional sense. And for most patients, they can avoid surgery and avoid being on medications on a daily basis.
What would the surgical option have entailed if they couldn’t get relief with medication?
LEVITIN: So we’re basically treating the inferior turbinate, or the tissue that gets spongy when it gets congested. In the past, we would do several types of procedures to either shrink that tissue, burn that tissue or even cut out part of that tissue. And those have a lot of side effects, meaning that people are very congested, very crusty, very miserable. Not only that, but they’re often done under general anesthesia. So in this case, we’re avoiding surgery entirely, avoiding the two to three-week recovery period and really giving patients a completely new opportunity to treat their symptoms without any of the negative side effects that we had in the past.
Are those are painful procedures?
LEVITIN: It goes without saying that a lot of these surgical procedures are often very painful or at the very least very uncomfortable. But most of our patients will describe this as essentially one of the easiest procedures they’ve ever undergone.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Ilana Nikravesh, PR
347-852-3382
ilana.nikravesh@mountsinai.org
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