US-based medical device company Torax Medical has received a positive recommendation from the US Food and Drug Administration's (FDA) Gastroenterology and Urology Devices Advisory Panel for its LINX reflux management system.
The LINX reflux management system is a flexible ring of interlinked, miniature titanium beads with magnetic cores, designed for the treatment of gastro-oesophageal reflux disease (GERD). The device is placed around the oesophagus just above the stomach using a standard laparoscopic procedure, to augment the existing sphincter preventing it from opening to acid and other reflux. The magnetic attraction between the beads is intended to help the sphincter resist opening to gastric pressure, preventing reflux from the stomach into the oesophagus, and letting higher pressures from swallowing overcome the magnetic forces, allowing food and liquid to pass normally into the stomach.
The FDA advisory panel affirmed the efficacy, safety and risk-benefit ratio for the reflux management system, while Torax Medical chief executive officer Todd Berg said they the company was happy that the Gastroenterology and Urology Devices Advisory Panel recognised the clinical benefits of the LINX System. ''We look forward to working with the FDA to reach a final decision on approval to make the LINX treatment available to patients in the US,'' he added.
In the US, the LINX system is not approved for commercial distribution and is currently limited by Federal law to investigational use.
The company said chronic exposure of the oesophagus to reflux may lead to numerous complications including ulcerations, Barrett's oesophagus and oesophageal cancer.
Headquartered in Minnesota, Torax develops and markets products designed to treat sphincter disorders.
The company's technology platform magnetic sphincter augmentation (MSA) is currently marketed in Europe as the LINX reflux management system for the treatment of GERD and the FENIX continence restoration system for the treatment of fecal incontinence (FI).