Top U.S. Medical Centers Offering New Minimally Invasive Procedure for Reflux Disease

Tue Apr 24, 2012 7:00am EDT

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Top U.S. Medical Centers Offering New Minimally Invasive Procedure for Reflux Disease

Torax Medical today announced Keck Medical Center of USC, Mayo Clinic Florida, and UC San Diego Health System of UCSD are among the first centers offering a new procedure using the LINX® Reflux Management System, recently approved by the U.S. Food and Drug Administration (FDA). The LINX System is indicated for use in patients diagnosed with Gastroesophageal Reflux Disease (GERD).

President and CEO of Torax Medical, Todd Berg, stated, “The LINX System is one of the most comprehensively tested devices for reflux disease, including two FDA regulated clinical trials. This has allowed us to engage top U.S. medical centers and offer this option to their patients. LINX will be available to additional centers once they complete pre-qualification requirements and training programs.”

The LINX System

The LINX System 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 with a standard minimally invasive laparoscopic procedure and is an alternative to the more anatomically disruptive fundoplication, commonly used in anti-reflux surgical procedures.

Dr. C. Daniel Smith, past President of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), shared this perspective, “I expect the LINX System to change how surgeons and patients look at reflux disease. We now have a new option for patients, which appears to offer a better balance of benefit to risk. In the past, patients have had to weigh the severity of their symptoms to the side-effect risks of their surgery. For select patients who have failed management with drugs this is a significant new treatment option.”

On April 10, Bettina Kilburn of Atlanta was among the first in the nation to undergo the LINX procedure. “Even with PPI medications and strict lifestyle changes, my reflux had limited every aspect of my daily life. I finally came to a point where I knew I wanted neither decades of compromised lifestyle, nor dependence on medications that didn’t resolve my symptoms. I considered a Nissen fundoplication, but was concerned about side effects. I chose LINX because it offered me the possibility of a permanent solution. Within a day after my LINX procedure, I had retired my slant pillow and challenged the new ‘valve’ successfully with solid food, including chocolate. My recovery is an ongoing process, but one marked by the joy of new freedom.”

Dr. Tom DeMeester, Chairman Emeritus of Surgery USC Keck School of Medicine, commented, "We used to believe that this disease could be addressed with only acid suppression drugs. After years of this approach, we have found that the prevalence of the disease continues to rise resulting in higher healthcare costs and further complications such as pre-cancerous Barrett’s esophagus. Incomplete control of symptoms, continued risk of disease progression and significant side effects are all material limitations of these drugs. I am encouraged that we are now looking to address the primary source of this disease, which is the sphincter defect.”

The Disease

Gastroesophageal 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. Symptoms of GERD include heartburn, regurgitation, inability to sleep and dietary constraints. Acid suppression drugs, such as Prevacid®, Nexium®, and Prilosec®, affect gastric acid production, but do not repair the sphincter defect and allow continued reflux. Reflux can progress to a pre-cancerous condition known as Barrett’s esophagus and possibly esophageal cancer. Approximately 7% of adults in western countries suffer daily from symptoms of GERD.

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 both the LINX Reflux Management System for the treatment of GERD and its FENIX™ Continence Restoration System for the treatment of Fecal Incontinence (FI) in Europe. Investors include: Sanderling Ventures, Thomas, McNerney & Partners, Accuitive Medical Ventures, Kaiser Permanente Ventures, and Mayo Medical Ventures. For more information, please visit www.toraxmedical.com.

Tom DeMeester, MD and Daniel Smith, MD are paid consultants to Torax Medical.

Torax Medical, Inc.
Todd Berg, 651-361-8900
President and CEO

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