Stretta: not an option?

My docs don't do it. If you have a sizable hiatal hernia it's not going to do anything for it.

She did say that they told her that the insurance will not pay and they informed her up front about it.

hopegood,

I believe many doc's have gone away from stretta, as it has caused more problems than it resolved. Nissen is the "gold standard" with linx picking up steam as well.

Bryter-Later,

Wow, it's like looking in the mirror....I'm 42 yr old male, 5' 9" 125 lbs.

This is very interesting.....I thought stretta was done by "poking" several tiny holes to create scar tissue to "tighten" up the les. This however uses RF which is the same process as removing barretts. I was not aware of this type of stretta. I'd love to hear more thoughts on this from members.

Hi GERD Forum,

Full disclosure - I am Director of Marketing for Mederi who is the current owner of the Stretta technology. We are monitoring blogs and responding to make sure that patients have accurate information on our product.

Mederi purchased the assets behind Stretta (the former company folded due to financial and reimbursement problems), updated the technology, safety mechanisms, generator and training programs, and officially relaunched Stretta in 2012 (Stretta was available from Mederi in limited supply beginning in 2010). The technology was dormant (sleeping but still alive) during the change of ownership, update to technology, and updated FDA as well as CE (Europe) clearance.

Allow me to share some simple facts that are backed by clinical evidence (pubmed.com):
- Stretta has 32 clinical studies dating back to 2000, only three of these were company sponsored
- Of those there are multiple 4-year studies showing 75-86% of patients off their daily PPIs after Stretta
- Stretta 10-year follow-up data was just presented at Digestive Disease Week and submitted for publication
- A Meta-Analysis published last year examining data on 1,400 patients, shows Stretta offers improvement in every measureable outcome for GERD including reduction of acid
- There have been more than 15,000 Stretta procedures performed
- The adverse event rate of Stretta on the FDA database as well as in clinical studies is much less than 1%
- SAGES guidelines gave Stretta the highest recommendation possible due to the amount of clinical data

We are increasing our marketing to raise awareness so stay tuned – although as a small company our efforts are very grass roots and we focus more on product and training/education than mass marketing. Our best advocates are physicians like the SAGES organization who objectively examined the data and as you see in the link in the thread below and gave Stretta the highest recommendation possible (you can also read some of the abstracts of studies at that link). Stretta practicing physicians consist of GIs as well as Surgeons.

Stretta has been studied and proven, we have made very good progress with US insurance reimbursement coverage (Medicare in 12 southwest and midatlantic, states, also covered in VA centers, and by Tricare/military), and this coverage is growing. Stretta is currently available in almost 40 countries. New treatment options like the Linx are interesting and the data is promising, but simply it is still surgery and a magnetic implant, and must be removed if someone needs an MRI procedure (see Linx clinical study and website).

Stretta works in select patients – when patients don't respond to PPIs, have a smaller than 2 cm hiatal hernia – and would like an option other than surgery or an implant. It also works nicely after a Nissen surgery after the wrap loosens or if the surgery fails. Because Stretta doesn't rule out other treatments or procedures, it is a good option for many patients.

Only your doctor can determine if Stretta is an option for your GERD treatment.
FOR SAFETY INFORMATION ON STRETTA PLEASE GO TO THE LINK BELOW:
http://blog.mederitherapeutics.com/index.php/stretta-safety-information/

There is much "urban legend" regarding Stretta – so thank you for allowing me to set the record straight.

Sheila Doyle
Director of Marketing Communications
Mederi Therapeutics Inc.

Hi Pat Fill, may I ask how your neighbor is doing?

Thank you

Hi Forum and Pat Fill -

An implant like Linx around the LES is a contraindication for Stretta. Not just because the metal may react to the heat but because the RF energy in Stretta could be interrupted if a metal object or the like is in or near contact. It would need to be removed prior to Stretta.

The good news for patients is that there are options now - not any of them work for every patient. What is clear is that Stretta fits in the middle between medications and any kind of surgery to treat chronic GERD.

And you are correct on Post-Nissen as well as Post-Bariatric patients - Stretta has been studied and effective in those patient populations.

You may be interested to see the Stretta 8-year data just published yesterday from italy - here's the link to the study:
http://www.hindawi.com/journals/grp/2014/531907/

Thank you for your question.
Sheila Doyle
Director of Marketing Communications
Mederi Therapeutics Inc.

Hi Again Pat -

Only your doctor can tell you the required time after Linx removal surgery and before Stretta. And yes Stretta has been studied in patients with LPR - 500 patient study from China -
Here is the link to the study: http://www.ncbi.nlm.nih.gov/pubmed/21542958

Please see a trained Stretta physician to determine if Stretta is an option for your GERD treatment.

See below for the safety information on Stretta:
Safety Information
INDICATIONS FOR USE: The Stretta System is intended for general use in the electro­surgical coagulation of tissue and intended for use specifically in the treatment of gastroesophageal reflux disease (GERD).

CONTRAINDICATIONS: The use of electrosurgery is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interest of the patient. The following is a list of patient groups in which the use of the Stretta System for the treatment of GERD is contraindicated: subjects under the age of 18, pregnant women, patients without a diagnosis of GERD, hiatal hernia >2cm, achalasia or incomplete LES relaxation in response to swallow, poor surgical candidates, ASA IV classification, Patient has an implant near the LES that could be conductive with RF energy

WARNINGS: These complications are rarely seen but could potentially occur with the use of electrosurgery for the treatment of GERD: transient bleeding, bloating, transient chest pain, transient difficulty belching, transient dysphagia, transient epi­gastric discomfort, transient esophageal mucosal laceration, transient fever, Injury to esophageal mucosa, perforation, pharyngitis, vomiting transient with potential for bleeding or Esophageal injury. If any vomiting occurs, contact your treating phy­sician immediately. Excessive vomiting may result in perforation and more serious injury resulting in death. The following complications have not been seen, but could possibly occur infrequently: Achalasia, transient delayed gastric emptying, dental injury, dyspnea, infection, larynx injury, worsened GERD (Note: Consult physician or instructions for use for full contraindications, warnings and precautions).

Thank you for your question.
Sheila Doyle
Director of Marketing Communications
Mederi Therapeutics Inc.

Hi Wendy -

We are getting ready to train physicians on Stretta at UAB - but they haven't done cases yet. There are several in and around Atlanta that would be close and also in New Orleans. Most experienced would be Dr. Ed Lin in Atlanta and Dr. Gary Reiss in New Orleans. You can get their information at this link: http://www.stretta-therapy.com/physician-finder.

Thank you - let me know if you have any other questions.

Sheila

Hi Wendy -

Stretta doesn't have the same issue as fundoplication does with burping - but only a doctor can determine if you are the right kind of candidate for Stretta. It has shown very good success in LPR and some believe it is ideal for those who are "upright refluxers". You should review the studies on the Stretta website for the most complete information and safety considerations - then talk to a doctor about options. Interestingly there are some ENTs who also do Stretta and among GIs too there is some talk about "aero-digestive" specialties that would combine the upper and lower issues as they are usually connected.

Thanks!
Sheila

No problem Wendy - could be couple months on uab - but keep checking our stretta website physician finder it's updated daily. It is best to ask the physician how many they have done - I know dr. Lin has done a lot but don't know a figure.

Good luck and hope you will be feeling better soon!

Shiela,

I am having the Stretta Procedure tomorrow if my hernia is still small enough. I live near the New Orleans area and my GI dr will be performing it. I also have gastroparesis and had a partial Nissen a few years ago which had to be undone because of the GP? Am hoping I do well.