Heart burn is also referred to as gastro-esophageal reflux disease (GERD), which is a condition that occurs when food particles reenter the esophagus. Now, the US Food and Drug Administration has approved of the LINX Reflux Management System for patients of GERD.
For issuing the consent, the team conducted a trial to test the safety and efficacy of the LINX Reflux Management System. As per the results, the benefits of the system surpassed the risks associated with it.
Generally, people suffering from GERD are advised to undergo simple lifestyle modifications such as weight loss, smaller meals and avoidance of certain ingredients. Surgical treatment is advisable for patients of chronic GERD and those with a large hiatal hernia. It is also opted by people who wish to refrain from other long-term medications.
“The LINX Reflux Management System is a sterile, single-use, surgically placed device used to treat the symptoms associated with GERD. LINX offers an option to patients and their health care providers and is an alternative to current surgical procedures,” commented Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health.
Some of the side-effects reported were inclusive of swallowing difficulties, pain while swallowing, nausea, chest pain and vomiting. The LINX system comprises a cascade of titanium beads with a magnetic core on each of them. These cores are linked together with separate titanium wires that form a ring-like structure. It is planted at the lower esophageal sphincter (LES) that essentially prohibits the backward flow of stomach constituents.
Notably, patients with LINX should not be exposed to MRI scans as the magnetic beads may damage the machine and injure the patient. Torax Medical has manufactured the LINX Reflux Management System.