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TORAX LINX APPROVED BY FDA

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Posted 3/23/2012 8:47 PM (GMT 0)

FDA NEWS RELEASE

For Immediate Release: March 22, 2012
Media Inquiries: Morgan Liscinsky, 301-796-0397; [email protected]
Consumer Inquiries: 888-INFO-FDA

FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease

The Food and Drug Administration today approved the LINX Reflux Management System for people diagnosed with gastroesophageal reflux disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.

GERD is a condition in which food or liquid in the stomach flows back into the esophagus. This can irritate the esophagus, causing heartburn and other symptoms.

Patients with GERD are first advised to make dietary and lifestyle changes such as losing weight, eating smaller meals and avoiding certain types of foods that may trigger symptoms. There are medications available, such as antacids and proton pump inhibitors, for those who do not respond to dietary and lifestyle measures.

Surgical treatment usually is reserved for people who have severe symptoms such as chronic GERD or a large hiatal hernia, a condition in which part of the stomach pushes upward through the diaphragm. Surgery is also an option for those who do not follow their recommended medical therapy or who want to avoid a lifetime of medical therapy.

“The LINX Reflux Management System is a sterile, single-use, surgically placed device used to treat the symptoms associated with GERD,” said Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health. “LINX offers an option to patients and their health care providers and is an alternative to current surgical procedures.”

The LINX system is composed of a series of titanium beads, each with a magnetic core, connected together with independent titanium wires to form a ring shape. It is implanted at the lower esophageal sphincter (LES), a circular band of muscle that closes the last few centimeters of the esophagus and prevents the backward flow of stomach contents.

The force of the magnetic beads is designed to provide additional strength to keep a weak LES closed. Upon swallowing, the magnetic force between the beads is overcome by the higher pressures of swallowing forces, and the device expands to accommodate a normal swallow of food or liquid. Once the food passes though the LES, the device returns to its resting state. 

The company conducted a feasibility study of 44 patients at four centers with a five-year follow-up plan. In addition, the company conducted a pivotal study of 100 patients at 14 centers with a five-year follow-up plan. Patients enrolled had GERD and chronic GERD symptoms, despite medical therapy. Results from both the feasibility and pivotal trials indicate that the benefits obtained with the LINX Reflux Management System outweigh its risks.

As a condition of approval, the company will institute a required training program to educate new users on patient selection, device implantation and post-procedural care of patients treated with LINX.

The most common adverse events experienced with the LINX included difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea.

It is important to note that patients with LINX will no longer be able to undergo Magnetic Resonance Imaging (MRI) procedures. The magnetic beads interfere with the machine and can cause the device to be damaged and the patient to be injured.

The LINX Reflux Management System is manufactured by Torax Medical Inc. in St. Paul, Minn.

For more information:

Posted 3/24/2012 12:32 AM (GMT 0)
wow, this is good news. Hopefully Prevacid will continue working for me until 10 yr long term follow-up data is available for the LINX. I don't want to be on PPI's forever and the LINX sounds like a much simpler option than the Nissen. It's also nice that I could still have a Nissen after having a LINX if the LINX were to be ineffective.

Liz
Posted 3/24/2012 2:25 AM (GMT 0)
Finally good news!
Posted 3/24/2012 5:09 PM (GMT 0)
Great news for our members who have been waiting for this approval.  So far Torax has not issued a press release on their site but I am sure it will be there soon.

Thanks Raj2011 for posting this info.

Kindly,

Kitt

Posted 3/26/2012 12:57 AM (GMT 0)
Torax Medical has updated their website.

So, the next question is .. which medical centers are going to start offering this and when? My guess is those medical centers that were involved with the trials will be the first to offer it.

I doubt if the insurance companies will cover this for a while. I am still struggling with the insurance companies to cover TIF - which has been around for so many years and even after ASGS (American Society of General Surgeons) has already endorsed it!
Posted 3/26/2012 5:46 AM (GMT 0)
Yes, agree.  It will be really hard to get insurance companies to pay for the Linx. I think it's just too new and there are no long-term studies yet.

Sal

Posted 3/26/2012 3:42 PM (GMT 0)
Awesome news! Thanks for posting.

And yes, I'm betting that most insurance won't cover it for a while. Thus the question is, how much will the procedure cost for paying straight out of pocket? $10,000, $15,000, more? I'm guessing it will probably be in that range, based on what I've seen in the U.K.

Also, this may not be the place to ask it, but how is the LINX device secured in place? What prevents it from moving around if you go for a long run or jump on a trampoline, etc.?
Posted 3/26/2012 5:34 PM (GMT 0)
GREAT NEWS!!!!!
For all of you out there waiting you won't be disappointed. Hopefully insurance companies will decide to cover the Linx right away. Mine is still going strong with very little problems. Good luck to all. Shooz
Posted 3/26/2012 6:15 PM (GMT 0)
Thanks Shooz! Are you still off all PPI's? Do you have any ongoing challenges with side effects (esophageal spasms?), etc.?
Posted 3/26/2012 6:24 PM (GMT 0)
My guess would be that the insurance companies would want to cover the Linx pretty quickly. It's probably an easier and less expensive procedure than fundoplication, and with a quicker recovery time.

speedygerd, I think the Linx is held in place by a couple of things. Once it's in place, the body naturally surrounds the implant with new tissue. Also as I understand it, the surgeon makes a small opening between the esophagus and the vagus nerve bundle, and passes the Linx through that opening, so that would probably hold it in place also.
Posted 3/26/2012 7:00 PM (GMT 0)
Speedygerd,
I went back on the PPI's last year after my surgeon found a small leak near the LES. I'm hoping to try again to stop them. The only issues that I have had are some foods getting stuck at the LES. That has improved greatly as time goes on. Sticky things still cause me problems, I have to remember to do a better job of chewing. As I have discussed in some of my past posts I never looked back!! I have a much better quality of life now. Good luck. Shooz turn
Posted 3/26/2012 7:06 PM (GMT 0)
@speden

Good point about the vagus nerve bundle and the new tissue holding it in place. I just keep having weird visions of it slipping out during vigorous activities, but I imagine they've investigated that quite extensively.

Unfortunately, I have to disagree with you on the insurance company coverage however. I think the same argument could be made for the Esophyx TIF procedure, but it sounds like very few companies cover that yet either.

I think many insurance companies only pay for the NF because it is a much more invasive procedure and they know that a lot of people will opt to not have this more life altering surgery and just live with GERD instead. The easier the surgery, the more people are going to want it, so they save themselves money in the long run by only covering the more invasive procedures.

They can also then use the "experimental technology" labels to defeat the newer and more palatable surgeries and provide a less attractive option in the NF.

I certainly hope I'm wrong, but PPI-LESS's experience with the TIF seems to confirm it. Hopefully the long term results from the Linx turn out to be so good that they can't not cover it!
Posted 3/27/2012 12:55 PM (GMT 0)
I don't think the success rate and long term results for TIF are very good compared to fundoplication, so that's probably why insurance may not pay for TIF. Insurance companies see fundoplication as the gold standard for long term reflux treatment. It's been around a long time and has a pretty good success rate.

I wouldn't put the Linx in the same category as the Esophyx TIF. The Linx is essentially a greatly simplified, and easily reversible fundoplication procedure, so that's why I think insurance companies may consider covering it. But we'll have to see what they decide.
Posted 3/27/2012 2:12 PM (GMT 0)
I would be very surprised if the insurance companies will start covering Linx without waiting for the results (which might take at least a few more years)

In general, insurance companies are really not willing to experiment with GERD procedures - especially because:
- Most GERD patients are able to use medications and are able to control their symptoms.
- Remaining GERD patients mostly fall into the 'severe GERD' cases and they are not that unwilling to go with Nissen (which has been around for a long time and is a GOLD standard for severe cases)
- There are very few GERD patients like me - who are not able to tolerate the medications - yet - don't quite have 'severe GERD' symptoms and pH results.

So, the physicians who review cases at the insurance companies don't quite understand / appreciate the unique situations like mine. I am going through the appeal process with them - to make them understand my (relatively) unique situation - since I feel I do make an ideal candidate for the TIF procedure. I expect this process to take another 3-4 weeks to complete.
Posted 3/27/2012 7:49 PM (GMT 0)
How about the pateints who have to get NF done....LINX would now be an option for them. Ofcourse, the insurance companies will need to approve that first...but in terms of cost, i think LINX is going to cost them less compared to NF. And i am quite sure, TORAX will be already trying to sell this to the insurance companies or making up plans. TORAX will be making much more money if insurance approves it, and not otherwise.

Raj
Posted 3/28/2012 3:11 PM (GMT 0)
Torax put out a press release yesterday on the Linx. Here are some excerpts:

President and CEO of Torax Medical, Todd Berg, stated, “After years of extensive development and clinical studies, we are pleased to have the LINX System available to patients in the U.S. suffering from GERD. Torax will immediately begin training new centers throughout the U.S. We will work with medical centers that have a specific expertise in the treatment of reflux disease to create ‘Centers of Excellence’ for the LINX System. Patients will have access to the LINX procedure within the next 30 days.”

…

Dr. Tom DeMeester, Chairman Emeritus of Surgery USC Keck School of Medicine, further commented, "Chronic gastroesophageal reflux is a serious and progressive disease primarily resulting from a defect in the lower esophageal sphincter. I am impressed with the extensive clinical study of the LINX System which resulted in a unanimous recommendation for approval by a FDA Advisory Panel, followed now by FDA approval. The LINX System is a needed alternative to the current surgical anti-reflux procedure, Nissen fundoplication, originally developed over 50 years ago.”

“The FDA‘s process to approve the LINX System has been rigorous and thorough. We are pleased to be able to offer an innovative and much needed medical device option to patients and their healthcare providers for treatment of the debilitating symptoms of this disease,” noted Timothy Mills, Ph.D., Chairman of Torax Medical and Managing Director, Sanderling Ventures.

Here's a link to the full release:

www.toraxmedical.com/news/downloads/PR_LINXFDAApproval.pdf
Posted 3/28/2012 3:32 PM (GMT 0)
What if you don't have insurance?

Does anyone think I would still be able to get it?

What if I go to one of the county hospitals in my state?

Would they provide the procedure?

Can you get a surgery without insurance in California?
Posted 3/28/2012 3:49 PM (GMT 0)
Nickles,

If you don't have insurance you would have to pay out of your pocket.  I do not believe that any county hospital is going to provide this procedure and at this time I would doubt that they have any surgeons that perform this surgery. 

You can get any surgery you choose without insurance if you have the $$ to pay and the surgeon feels you have a need. 

Kindly,

Kitt

 

Posted 3/28/2012 4:31 PM (GMT 0)
There was some discussion around this before, but I don't remember what the consensus was .. but I was wondering if LINX device can be implanted even on those patients who've had TIF or Nissen - but are still not fully asymptomatic?
Posted 3/28/2012 6:57 PM (GMT 0)
@PPI-LESS

I don't know about the TIF, but I suspect it would be difficult to do with someone who already had a NF, as the area of the LES is already covered by the stomach wrap.
Posted 3/28/2012 7:58 PM (GMT 0)
Hello everyone, first off hurray to the torax being approved. Iv been kinda stressing also about if my insurance is going to pick this procedure up or not. To me this is a no brainer compared to the other surgerys that are out there for gerds. I had read that the torax results are as good or even better than the nissen results and your still able to burp and vommit. If the ring doesnt work out its easy enough for them to remove it. PPI-LESS, i am in the same boat as you are with the ppis. I have been on them for 14 years and am only 26 years old. At first they were a godsend and later on they were poison to me. I dont use them like i used to but occasionally am forced to use one to keep the reflux down. They work great but the side effects are just to much for me to take. If my insurance doesnt cover this i will jump through hoops to plead my situation or just end up paying whatever , but i do know i will not let myself keep taking these poisonous pills and allow myself to be sick everyday because of a little reflux. Its a no brainer for me.. Best of luck to everyone.
Posted 4/2/2012 12:10 AM (GMT 0)
Hello Shooz.

I have a question foy you.

You have a hiatal hernia?

How old are you?


I sorry i don't speak much english, I have 18 years old, and i dont want the fundoplication get.

I am nervous.

confused

Post Edited (Kenpo_Miguel) : 4/1/2012 6:14:55 PM (GMT-6)

Posted 4/2/2012 7:34 PM (GMT 0)
Hi Kenpo,
I will be 60 in 4 weeks. I did have a hiatal hernia less than 2 centimeters. It was fixed during the surgery. The best way to ease all of your fears is to have a conversation with your doctor and let him or her know what your fears are. The best doctors are the ones that will talk and listen to you. Good luck to you. Shooz
Posted 5/1/2012 3:09 AM (GMT 0)
Shooz

Is the pain swallowing anything similar to
The pain swallowing when you has the bravo in?
My pain swallowing was so bad and I would
Get so depressed with the pain and that concerns
Me with the linx swallowing pain
Posted 4/18/2015 7:09 AM (GMT 0)
Hello Shooz

Can you let me know how are you doing now - I am on all meds possible and not really getting much relief. Considering LINX if I am eligible - how has it worked out for you? Can I ask who was the Dr that operated on you?
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