New 5-Year Results of a Landmark Study Confirm LINX Procedure as a Beneficial Treatment for Gastro-esophageal Reflux Disease
Study authors conclude LINX should be a first line therapy option for GERD sufferers
PR Newswire, St. Paul, Minn. (September 14, 2015)
Torax Medical announced completion of a landmark study confirming the long-term results of the LINX® Reflux Management System in controlling reflux-related symptoms and eliminating dependence on 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.
All patients included in the LINX study had pathologic levels of acid in their esophagus, had compromised quality of life from their reflux disease and were refractory to continuous PPI therapy (median duration of treatment with PPIs was 5 years). The study’s efficacy endpoints for success at 5 years, restored quality of life and reduced PPI dependence, were both met.
Robert Ganz, MD, FASGE, Chief of Gastroenterology, Abbott Northwestern Hospital and Associate Professor of Medicine, University of Minnesota commented, “This study demonstrates the LINX procedure provides significant and durable improvement in heartburn, regurgitation, PPI independence and quality of life. Patients can now have a relatively simple procedure to restore their sphincter function and avoid the invasiveness required in fundoplication procedures. In my view, LINX represents the next generation of anti-reflux treatment.”
At five years:
- 85 percent of patients were free from daily dependence on PPIs
- Bothersome heartburn was reduced to 11.9% from 89% at baseline
- Bothersome regurgitation was reduced to 1.2% from 57% at baseline
Because medications are less effective at managing regurgitation, the near elimination of regurgitation in this clinical study after LINX represents an extraordinary benefit for patients with this life-altering symptom. Importantly, no new safety risks emerged during the 5-year follow-up period. If needed, the device can be removed and the rates for reoperation were less than the expected range for other anti-reflux procedures at 5 years. Overall, patients in this clinical study achieved significant clinical benefits from the LINX procedure; these benefits are now shown to be sustained at 5 years.
The Disease
Gastro-esophageal Reflux Disease (GERD) is a chronic, often progressive disease resulting from a weak lower esophageal sphincter that allows harmful gastric fluid to reflux into the esophagus, resulting in both pain and injury to the esophageal lining. Symptoms of GERD include heartburn and regurgitation, often associated with chronic sleep disruption, and may also include persistent cough, excessive throat clearing, hoarseness and a feeling of a “lump” in the throat. Acid reflux medications, such as Prevacid®, Nexium®, and Prilosec®, affect gastric acid production, but do not repair the sphincter defect, allowing continued reflux. The FDA has issued a series of statements on possible side effects of long-term PPI use including: possible fracture risk, low magnesium levels, and clostridium difficile-associated diarrhea. More recently, a study out of Stanford University published in the journal PLOS ONE showed PPI use may increase the risk of heart attack.1 Anti-reflux surgery called Nissen fundoplication reconstructs a new reflux barrier using a portion of the patient’s stomach which is wrapped around the lower portion of the esophagus. GERD is associated with a pre-cancerous condition known as Barrett’s esophagus, which increases the risk of esophageal cancer.
The LINX Reflux Management System
LINX is a small implant comprised of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads augments the existing esophageal sphincter’s barrier function to prevent reflux. The device is implanted using a standard minimally invasive laparoscopic procedure and is an alternative to the more anatomically disruptive fundoplication, commonly used in surgical anti-reflux procedures. The LINX Reflux Management System is indicated for those patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
LINX does require a surgical procedure and is associated with potential risks, contraindications and life style modifications. For more information on LINX, including a statement of risks, please visit www.linxforlife.com.
About Torax Medical
Torax Medical, Inc. is a privately-held medical device company headquartered in St. Paul, Minnesota that develops and markets products designed to treat sphincter disorders utilizing its technology platform, Magnetic Sphincter Augmentation (MSA). Torax Medical is currently marketing the LINX® Reflux Management System for the treatment of GERD in the U.S. and Europe and the FENIX® Continence Restoration System for the treatment of Fecal Incontinence (FI) in Europe. For more information, please visit www.toraxmedical.com.
1. PLOS ONE | DOI:10.1371/journal.pone.0124653
Maggie Wallner
Torax Medical, Inc.
[email protected]
651-361-8900
LINX System - Abridged Brief Statement
LINX® Reflux Management System - Abridged Brief Statement
The LINX® Reflux Management System is indicated for those patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Contraindications: Do not implant the LINX System in patients with suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.
Warnings: The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T), depending on the LINX model implanted. Laparoscopic placement of the LINX device is major surgery.
General Precautions: The LINX device is a long-term implant for use in patients 21 years or older. Medical management of adverse reactions may include explantation and/or replacement.
Potential Risks Associated with LINX System: dysphagia, stomach bloating, nausea, odynophagia, increased belching, decreased appetite, inability to belch or vomit, flatulence, early satiety, device erosion, device migration, infection, pain, and worsening of preoperative symptoms.
For more information on the LINX Reflux Management System, contact your physician or Torax Medical, Inc.
For full patient information visit www.linxforlife.com or www.toraxmedical.com.