IFFGD Vice-President, William Norton, submitted the following written public testimony to the FDA in connection with a January 11, 2012 meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee to consider the premarket approval of the LINX Reflux Management System for the treatment of gastroesophageal reflux disease (GERD):

On behalf of the International Foundation for Functional Gastrointestinal Disorders (IFFGD), I would like to thank the Food and Drug Administration (FDA) for its work to evaluate the safety of treatments for conditions that affect the public. IFFGD is a 501(c)(3) nonprofit education and research organization dedicated to improving the understanding of functional gastrointestinal and motility disorders. Our mission is to inform, assist, and support people affected by painful and debilitating digestive conditions for which too few treatment options exist.

I write to you today in response to Docket No. FDA-2011-N-0002 regarding the January 11, 2012 meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. At this meeting, the Panel will consider the premarket approval of the LINX Reflux Management System for the treatment of gastroesophageal reflux disease (GERD).

GERD is a chronic condition which develops when the back-flow (reflux) of stomach contents into the esophagus causes troublesome symptoms and/or complications. The condition is often characterized by painful or problematic symptoms that can undermine a person’s daily life – emotionally, socially, and professionally. Additional serious health problems can result if it is not treated effectively. One uncommon but serious complication is Barrett’s esophagus, a potentially pre-cancerous condition associated with esophageal cancer.

There are several treatment options currently available for individuals suffering from GERD, including long-term use of medications and fundoplication surgery. Nonetheless, treatment response varies from person to person and is not always effective or desirable. Other treatment options are needed for GERD sufferers. If the Panel finds the LINX System to be a safe and effective therapy to relieve symptoms of GERD, it would be a significant step forward for patients.

Thank you for your consideration of our comments.

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