01.29.15
Torax Medical said it has completed a second five-year clinical trial for the LINX procedure to treat gastro-esophageal reflux disease (GERD). Previous reporting of safety and efficacy for this pivotal trial provided the scientific evidence necessary for U.S. Food and Drug Administration (FDA) approval for the LINX device in early 2012.
“Completion of this pivotal trial is a momentous achievement for the study investigators. The vigilance necessary to perform a study of this magnitude is significant and critical for the advancement of minimally invasive surgery,” said Tom R. DeMeester, M.D., chairman of the Medical Advisory Board for Torax Medical and Chairman Emeritus, University of Southern California's Department of Surgery. “This new data provides an essential basis for the long-term durability of the LINX procedure. GERD is a chronic condition and needs a minimally invasive treatment option when the disease becomes progressive.”
Torax Medical’s LINX Reflux Management System was studied as an Investigational Device Exemption under regulatory oversight of the FDA starting in 2007. The multi-center, prospective, pivotal trial was statistically powered to establish scientific evidence of safety and efficacy of the LINX procedure in the treatment of chronic reflux disease. Patients included in the pivotal trial were refractory to proton-pump inhibitor (PPI) therapy and had pathologic levels of esophageal acid exposure. The long-term efficacy endpoints evaluated at five years were control of reflux related symptoms and reduction in dependence of PPI therapy. Preliminary assessment of these endpoints, with more than 80 percent of available patients reporting, showed that 86 percent of patients continue to have significant reduction in their reflux symptoms and 86 percent have eliminated their daily dependence on PPI therapy. These results are consistent with the three-year clinical outcomes previously reported from this study in the New England Journal of Medicine, the company claims.
"Torax Medical and physician thought leaders have now collaborated for over a decade building a foundation of evidence to support the safety and efficacy of the LINX procedure. Top U.S. medical journals have already reported on over 1,000 unique patients treated with the LINX procedure," said Todd Berg, president/CEO of Torax Medical. "This five-year pivotal study is an excellent capstone to this effort."
Gastro-esophageal Reflux Disease 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. 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.
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.
Torax Medical is a privately-held medical device company headquartered in St. Paul, Minn., that develops and markets products designed to treat sphincter disorders.
“Completion of this pivotal trial is a momentous achievement for the study investigators. The vigilance necessary to perform a study of this magnitude is significant and critical for the advancement of minimally invasive surgery,” said Tom R. DeMeester, M.D., chairman of the Medical Advisory Board for Torax Medical and Chairman Emeritus, University of Southern California's Department of Surgery. “This new data provides an essential basis for the long-term durability of the LINX procedure. GERD is a chronic condition and needs a minimally invasive treatment option when the disease becomes progressive.”
Torax Medical’s LINX Reflux Management System was studied as an Investigational Device Exemption under regulatory oversight of the FDA starting in 2007. The multi-center, prospective, pivotal trial was statistically powered to establish scientific evidence of safety and efficacy of the LINX procedure in the treatment of chronic reflux disease. Patients included in the pivotal trial were refractory to proton-pump inhibitor (PPI) therapy and had pathologic levels of esophageal acid exposure. The long-term efficacy endpoints evaluated at five years were control of reflux related symptoms and reduction in dependence of PPI therapy. Preliminary assessment of these endpoints, with more than 80 percent of available patients reporting, showed that 86 percent of patients continue to have significant reduction in their reflux symptoms and 86 percent have eliminated their daily dependence on PPI therapy. These results are consistent with the three-year clinical outcomes previously reported from this study in the New England Journal of Medicine, the company claims.
"Torax Medical and physician thought leaders have now collaborated for over a decade building a foundation of evidence to support the safety and efficacy of the LINX procedure. Top U.S. medical journals have already reported on over 1,000 unique patients treated with the LINX procedure," said Todd Berg, president/CEO of Torax Medical. "This five-year pivotal study is an excellent capstone to this effort."
Gastro-esophageal Reflux Disease 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. 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.
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.
Torax Medical is a privately-held medical device company headquartered in St. Paul, Minn., that develops and markets products designed to treat sphincter disorders.