Linx

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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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New 5-year results are in

September 14, 2015 via multivu.com

New 5-year results of a Landmark Study confirm LINX procedure as a beneficial treatment for gastro-esophageal reflux disease (GERD). Study authors conclude LINX should be a first-line therapy option for GERD sufferers.

Torax Medical announced the completion of a landmark study confirming long-term results of the LINX® Reflux Management System in controlling reflux-related symptoms and eliminating dependence on the acid suppression medications called proton pump inhibitors (PPIs). Findings from the clinical study demonstrated that the LINX procedure normalized the amount of acid in the esophagus, while safely and effectively relieving heartburn and regurgitation, and improving quality of life without the need for PPIs. The LINX device was approved by the FDA in early 2012 and is currently the only medical device approved by the FDA to be safe and effective for the treatment of gastro-esophageal reflux disease (GERD).

Authors of the clinical study, published this week in a leading medical journal [Clinical Gastroenterology and Hepatology (http://www.cghjournal.org/article/S1542-3565(15)00763-6/abstract) concluded LINX should now be considered a first-line anti-reflux therapy for appropriate patients.

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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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