Linx

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Torax Medical Inc. has partnered with selected medical centers in the United States to evaluate the safety and efficacy of the LINX device in patients with gastroesophageal reflux disease (GERD) who have undergone a previous laparoscopic sleeve gastrectomy (LSG) for obesity and are looking for an alternative to taking daily proton pump inhibitors (PPIs) or other anti-reflux medications. The purpose of the study is to see whether the LINX device can be used safely in people with GERD who have had LSG surgery and if it can reduce or eliminate GERD-related symptoms.

To qualify, patients must be at least 22 years old, had bariatric sleeve surgery at least 12 months ago, have documented symptoms of GERD (acid reflux), currently need to take daily GERD medication and meet other criteria. Participation in the clinical trial will last 1 years after the LINX device is implanted.

Note: The LINX device has not been proven safe and effective in patients who have undergone LSG surgery which is the purpose of this research. As a result, there are both known and potentially unknown risks associated with LINX surgery for people who have had LSG surgery. 

More information can be found on the National Institute of Health, clinicaltrials.gov website: https://clinicaltrials.gov/ct2/show/NCT02429830?term=TORAX+RELIEF&cond=GERD&rank=1

CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use. The LINX device is approved in the US to be used for patients who have never had gastric (stomach) surgery.

The CALIBER Trial is a multi-center randomized controlled trial comparing LINX to acid suppression medication (omeprazole) in patients with troublesome regurgitation.  All patients had a diagnosis of GERD as confirmed by abnormal acid exposure time and moderate to severe regurgitation despite taking once-daily omeprazole.  Patients were randomized to treatment with twice a day omeprazole or LINX.  The primary endpoint of the trial was elimination of moderate to severe regurgitation at 6 months after treatment.  Preliminary results reported at DDW showed*:

  • 92.6% of patients treated with LINX achieved the primary endpoint success criteria versus 8.6% of patients treated with twice a day omeprazole.
  • Significant improvement in quality of life was achieved in 88.9% of patients treated with LINX versus 6.8% of patients treated with twice a day omeprazole.
  • Normal levels of reflux were restored in 92% of patients treated with LINX compared to 36% of patients treated with twice a day omeprazole.

*This data was presented at Digestive Disease Week 2017 (DDW) in Chicago, IL, by Dr. Reginald Bell, SurgOne Foregut Institute, Englewood, CO

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Torax Medical, Inc., a leader in devices to treat sphincter-related diseases, including gastroesophageal reflux disease (GERD), announced today that Health Care Service Corporation (HCSC), the 4th largest commercial health insurer in the U.S., has issued a medical coverage policy for the LINX® Reflux Management System effective April 1, 2016.

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Torax Medical, Inc., a leader in therapeutic interventions for sphincter-related diseases, announced today the release of new data from a 415 patient, multi-institutional study, comparing magnetic sphincter augmentation to laparoscopic Nissen fundoplication (LNF) for control of reflux. The study was led by Brian Louie, MD, Director, Thoracic Research and Education and colleagues from the Swedish Medical Center in Seattle, Washington. Collaborating centers were led by John Lipham, MD, Chief of Upper GI and General Surgery at Keck School of Medicine of USC in Los Angeles, California and Paul Taiganides, MD, Director of the Heartburn Treatment Center at Knox Community Hospital in Mount Vernon, Ohio.

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Torax Medical, Inc., a leader in therapeutic interventions for sphincter-related diseases, including gastroesophageal reflux disease (GERD), announced today the American Medical Association (AMA) has created a new Category 1 Current Procedural Terminology (CPT®) Code for esophageal sphincter augmentation using the LINX® Reflux Management System effective January 1, 2017. The LINX device is placed with a minimally invasive laparoscopic procedure and is intended to restore control of abnormal reflux.

“The AMA’s assignment of a specific code for esophageal sphincter augmentation not only validates the clinical need for the LINX® device, it also confirms the procedure has achieved the necessary level of utilization and clinical evidence to be included in the U.S. healthcare coding system. Support for the new code came from both Gastroenterological and Surgical Specialty Societies, whose members treat patients with GERD and recognize the need for better treatment options. Importantly, this code will provide surgeons who perform anti-reflux procedures a specific means to communicate with payers when performing the LINX® procedure,” stated Todd Berg, President and CEO of Torax Medical.

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Would you like Torax Medical to send information on LINX to the doctor currently treating your reflux disease?

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The information provided on this website is not medical advice and is intended for educational purposes only. Talk to a doctor if you have concerns about your health. Call 911 in the event of a medical emergency. Please do not submit medical information to this website or request treatment advice. For more information about the benefits and risks of LINX please click here.

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