Torax Medical Announces FDA Approval of a New LINX® Device Compatible with 1.5 Tesla Magnetic Resonance Imaging (MRI) Systems

ST. PAUL, Minn.–(BUSINESS WIRE)–Torax Medical, Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a next generation LINX® Reflux Management System that is MR conditional in magnetic resonance imaging (MRI) systems up to 1.5 Tesla (1.5T), which represents about 90% of MRI systems in use in the U.S. The LINX 1.5T design contains a different grade of magnets that have a higher resistance to being demagnetized when subjected to external magnetic fields (i.e. MRI).

“We are pleased to make this next generation LINX device available to patients seeking relief from their reflux symptoms while broadening their access to diagnostic imaging options after treatment”

“We are pleased to make this next generation LINX device available to patients seeking relief from their reflux symptoms while broadening their access to diagnostic imaging options after treatment,” said Todd Berg, President and CEO of Torax Medical.

Patients considering the LINX procedure should consult their healthcare provider regarding any questions related to MR imaging. Patients who have already received a LINX implant should consult their provider prior to undergoing any MRI tests. Information on diagnostic imaging options with LINX is also available at www.linxforlife.com and www.toraxmedical.com.

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. GERD is associated with a pre-cancerous condition known as Barrett’s esophagus, which increases the risk of esophageal cancer. 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 The alternative surgical option to LINX is Nissen fundoplication. 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.

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.

¹PLOS ONE DOI:10.1371/journal.pone.0124653