Mayo Clinic offers newly approved treatment for acid reflux disease
A novel device, a ring of tiny magnetic titanium beads, acts to keep stomach acid from leaking into the esophagus. Mayo Clinic in Florida helped test the device in patients.
JACKSONVILLE, Fla. — Mayo Clinic in Florida will be one of the first health care institutions in the United States to offer a newly approved device to treat gastroesophageal reflux disease (GERD). The condition, also known as acid reflux disease, can lead to serious health problems.
The U.S. Food and Drug Administration (FDA) approved the device and treatment procedure on March 22 for patients with GERD who continue to have chronic reflux symptoms despite taking medication.
Mayo Clinic in Florida expects to offer the new treatment immediately, says C. Daniel Smith, M.D., chair of the Surgery Department at Mayo Clinic in Florida, and an internationally recognized expert on the treatment of GERD.
Dr. Smith is experienced in using the system because Mayo Clinic in Florida was one of only 14 centers nationally that participated in a clinical trial that led to the FDA’s approval of the device.
“Mayo has been a leader in the treatment of esophageal diseases, especially GERD, and we are pleased to be offering this new treatment to our patients immediately,” he says.
GERD is a condition in which liquid, or food, in the stomach flows back up into the esophagus due to the inability of a ring of muscle between the lower esophagus and the top of the stomach to close properly.
If drugs aimed at neutralizing the acid in the stomach fails to prevent GERD, an operation designed to correct the mechanical defect is considered. But between 1.5 million and 2 million patients of those patients could benefit from treatment that is much less complex than current surgical options, Dr. Smith says.
“The new system will offer a long-needed treatment option for a large group of underserved patients,” he says.
The results of the clinical study that led to approval of the device have not yet been published. But “the data presented to the FDA revealed striking results when compared to other GERD treatments that have been investigated over the past 20 years,” Dr. Smith says. “The system offers effective control of GERD with limited side effects and thus far an excellent safety record.”
The implanted device is a ring of tiny magnetic titanium beads that is wrapped around the junction between the stomach and esophagus, serving as a mechanical augmentation of the lower esophageal sphincter (the ring of muscle). The magnetic attraction between the beads is strong enough to keep the sphincter closed to refluxing acid, but weak enough so that food can pass through it into the stomach, Dr. Smith says. The device can be implanted using minimally invasive surgery methods.
Dr. Smith performs about 200 GERD-related surgeries a year and has been involved with many new treatments over the past several decades. “I expect this device to be a game changer for the treatment of GERD in select patients who have failed management with drugs,” says Dr. Smith.
Ken DeVault, M.D., chair of the Department of Internal Medicine at Mayo Clinic in Florida, also participated in these studies. “I have many patients who are searching for something more than medication for their reflux, but have been hesitant to undergo a traditional reflux surgery,” he says. “I think this procedure may well be a very attractive option for that group.”
Drs. Smith and DeVault were consultants to the company that developed the device and participated in the research study. Mayo Clinic licensed related technology to the company in exchange for equity.
Download a PDF of the news release here
Journalists: The following audio and video clips with Dr. C. Daniel Smith are available for download and use in your stories.
Announcing the new treatment: MP4
An Intro to GERD: MP4
Device Overview: MP4
Patient Selection: MP4
More Information: MP4
Below is an edited youtube video of Dr. C. Daniel Smith announcing this newly approved treatment for acid reflux disease. You may embed it with your stories.
Contact information regarding this release:
Kevin Punsky
(904) 953-2299 (days)
(904) 953-2000 (evenings)
punsky.kevin@mayo.edu
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My husband has had severe gerd for several years. It has been somewhat controlled with diet and medication, however he has been having increasing episodes of emesis at night. Last night he ate pizza at about 7:30pm and he was up til at least 10:00. He was up twice through the night with severe emesis, and then when he was in the tub, this am, had an episode of emesis resulting in passing out and hitting the back of his head on the tub. 911 had been dialed, but he awakened and was alert and oriented times three. His vital signs were stable and he refused to go to the hospital at that time. When he gets sick at night he has stated “it feels like razor blades when throwing up”. He has never really been offerred any options other than the medication. He is eating earlier, and has been sleeping with the head of the bed elevated for years. And we have even invested in an adjustable bed, so he can keep his head up. I would appreciate more information on treatment options, especially the new magnetic implant, and any other information.
What is the cost of this new treatment?
Does it cause metal detectors to go off in the airport?
How does it compare to EsophyX Transoral Incisionless Fundoplication surgery? They create a similar contrictive valve on the LES.
We’ll check for you.
I had the Esophyx x oral transoral done two weeks ago ,iam still suffering from reflux it did not seem to make a difference. Could this new surgery still be performed on me ?
Thank you for your message. If you would like to seek help from Mayo Clinic, please call one of our appointment offices in Arizona at 480-301-1735; Florida, 904-953-0323; or Minnesota, 507-284-2511.
Hello,
What is the cost of this surgery.
Would you know if it is approved in Canada?
Thank you for your note. We do have a department that might be able to answer your questions regarding cost of the procedure. If you would like to contact the Fee Estimates area either at http://www.mayoclinic.org/billing-rst/ or by phone at 507-284-4027 they may be able to help.
Hi,
I have been in treatment of GERD for several months without any improvement. I would like to know the cost of this surgery. I’m in Guatemala, just for your information. Could you please send any other information to my email, thanks in advance.
We are checking on this for you.
hi,i did nissen fundoplication opration almost last year. but i feel that i still have reflux and i have been using imprazool. but i think it hasn’t work.i want to know if i can do linx antireflux device? could you please send any other information to my email, thanks in advance.
Hello Mahsa. We would recommend that you request an appointment to have that question answered by one of our physicians. Phone numbers and information on requesting appointments can be found here: http://www.mayoclinic.org/patientinfo/appointments.html.
Hello! I have a 11 years old boy with a Funduplication surgery, which is not working well due it got loose. My question is if can be possible for him the surgery to implant the ring. Thankyou!
Micaela, we wish your son the best; unfortunately, we cannot diagnose conditions, provide second opinions or make specific treatment recommendations through this correspondence. If you would like to seek help from Mayo Clinic, please call one of our appointment offices. The numbers can be found at http://www.mayoclinic.org/ under “request an appointment.”
Please direct me to whomever can answer this question. I have severe dismotility of my esophagus. I have had GERD my entire life. I have been treated with Nexium and Zantac for almost 25 years. My voice is very hoarse and I still have frequent reflux, although I do not feel heartburn. Would the newer method with the titanium magnets be appropriate for my condition? I am having difficulty finding a surgeon who will deal with my issues due to the dismotility. Thank you!
Hi Deb, Thank you for your comment. Unfortunately, we cannot diagnose conditions, provide second opinions or make specific treatment recommendations through this correspondence. If you would like to seek help from Mayo Clinic, please call one of our appointment offices. The numbers can be found at http://www.mayoclinic.org/ under “request an appointment.”
Bom dia,fiz a cirurgia de correção de refluxo mas nada adiantou eu estou pior,já passei por varios gastro renomados aqui no Brasil eles só dizem que meu caso é raro,minha cordas vocais estao todas derretidas por causa do acido,já perguntei de anel vai demora chegar aqui no Brasil eles não sabem dizer,eu sinto dor 24 horas por dia estou a base de tecta e digedrat,não sei mais o que fazer,até mais.
I am a US citizen living in Germany. Will this procedure be available here anytime soon? I suffer daily from acid reflux. The medications do not alleviate the burning, and they have caused me to visit the emergency room twice with panic attack symptoms. I am really interested in this new procedure, and if it will not be done here in Germany, would it be difficult for me to have it done in the States?
Yours truly,
Cheryl Hornung
Marburg, Germany
I need to know the name of the procedure that is used to place the linx device. If you could provide the H-ICDA code as well, that would be very helpful. My insurance requires specific information before they will say if they cover the procedure. Many thanks in advance.
ps: for the person in Germany, I think the linx device has been approved in Europe (and UK) for a long time. I might be wrong, but it for sure is done in the UK.
Is this an outpatient procedure?
I have had acid reflux for many years. I was told that the opening to my stomach was like a volcano and I had a hiatal hernia. So, I did what the pulmonary doctor told me to do. We got an electropedic bed, because with putting our bed up on blocks made my Irish husband say, “ok, now the marriage is going down hill from now on” with his little Irish smile. Then I could sleep upright and also avoided certain foods. Sleeping upright for many years was terrific for my face and a heart monitor nurse said it is good for other health factors too. How ever life is stress. We have raised 8 children in a full time blended family, five under 5 and three teenagers. They are all 43 to 58 years old, 19 grandchildren and 11 great grandchildren. They are all successful contributions to society and their families. We also, last July, took in a granddaughter who needed a soft and loving place to fall. We had a policy in our home as follows after they left home. If you have a problem, try to figure it our for yourself. Still having a problem? Call us for ideas. Still having a problem and your back to the wall? Come home to regroup, but here are the rules. You must be working your way out by finding solutions, going to school and most of all YOU CAN NEVER BE HAVING MORE FUN THAN WE ARE ABLE TO HAVE
. We have never been very well of financially and have worked very, very hard with very high credit scores, even at our worst of times. The children would ask us why we did not go out on dates like their friends parents. So one Saturday afternoon we went to a movie in the afternoon. We sat in the back of the theater and we did not intend to do so, but we went fast to sleep and awoke to an empty room. So, our fun was just raising good solid citizens in a loving and hard working family. However, our only down time was crawling into bed knowing our children were all tucked in bed, even as teenagers,and we had given good measure running over to our employers and each other. HOWEVER, I was a health food advocate since I was 34, so we ate very simple foods, no sweets except for birthdays and special occasions. For Christmas I would take the five little ones to the grocery store and they could pick out any sugary cereal in a box that they wanted to get. It took them at least a half hour to decide. The boxes were lined up on the table and they would exchange a cup with a sibling. I also have gone to an ND and nutritionist for many years, along with having an excellent diagnostic physician. Therefore, I am 77 but in excellent condition, despite having had 16 surgeries in my life time. I am full blooded Norweigian, so genetically I guess I have that as a plus too.
HOWEVER, I the reason I had the Fundoplication surgery is because I have to have both of my knees replaced since I have had 5 knee surgeries and can no longer exercise the way I should be doing. They told me I would have to be laying flat during the recovery and I said “I have not laid flat for many years.” Therefore, it was decided that I should have the Fundoplication Surgery. (edited out name- RP, from Center for Social Media) I have had the surgery and am doing quite well so far. However, several things were not done properly. One was that I was not given a deeper understanding about the process of the surgery, or before the surgery any information about what I would need to eat on a progressive scale after the surgery, so that we could have what we needed on hand before the surgery. Also, we wish they had called in the RX’s that we needed instead of giving us written ones as we left the hospital. Therefore, we could have quickly picked them up on the way home. Before I left the hospital the nurse said that I had to eat something before I left. The dietitian came in to us and gave me two pieces of information, then told me to call the kitchen and get a meal of soft food. The woman asked if I wanted chocolate pudding. I didn’t know and it was soft. The turkey was just ground into small pieces and zucchini slices with firm edges. I had sense enough to chew and chew before swallowing. Then I read the information and found out that I was suppose to only have liquids/broths for two weeks and absolutely NO chocolate. Then pureed food for at least a week etc.etc. I had five incisions in my belly and my shoulders ached. I am an OUT OF THE HOSPITAL AS QUICK AS POSSIBLE person, so I went home the evening of the second day, thank goodness. My husband and I are doing our due diligence now, but we wish there had been more information provided by the doctor and the printed nutrition information given before the surgery. After the surgery 4 other doctors came into my room, but I never saw the main surgeon. It gave me the feeling that I might have been a human living “cedavor” to teach other doctors how to do the procedure. They all came in smiling like I had had a baby and they were all thinking they were the fathers.I am doing ok, I think, but I doubt that I will get a call to check on how I am doing from the doctor.The surgery was on Thursday, I came home last night about 8:30, as we live in the country and about 40 miles from the hospital. When I know learn that the people who have this surgery have a shorter life span, it gives me pause. Hopefully, my having been health aware for so many years, I will beat the odds. Now, I am going to concentrate on as little stress as possible,and to educate my doctors about the process, along with suggestions for better preparing and communicating with their patients and available for other people contemplating this surgery.
Thank you for giving me an avenue as an outlet for my experience and some suggestions that I hope will help doctors become more aware of what patients need to know before this surgery and also just as important after the surgery.
Best regards,,
Martha Cannon
(edited out company, RP)
How many linx operations have been done thus far at the clinic?
Why visitors still use to read news papers when in this technological globe
everything is existing on net?
I have had this reflux problem for years. I even failed Nexium twoce a day. Now Im on dexilant two a day, the carafate syrup, at night along with dompidone, and trying to sleep sitting up at night. Im so ready for the new device. Does anyone know who and if its avatible in Houston, texas. thanks for your coment!Laura.
Thanks for your question, Laura. We will forward it along to Dr. Smith for his review and then get back to you with his response. Thanks again!
Hello, Laura. Dr. Smith recommends that you check the manufacturer’s website http://www.toraxmedical.com/linx/implantingCenters.php to determine its availability in Houston, Texas. Thank you.