Back in January we reported the FDA’s favourable panel review of Torax Medical’s LINX Reflux Management System, here. Back then we predicted that full clearance would not be far behind, and now we can report that the agency has now done the deed. LINX is now cleared for use in people diagnosed with gastro-(o)esophageal reflux disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.
GERD is a condition in which food or liquid in the stomach flows back into the oesophagus. This can irritate the oesophagus, causing heartburn and other symptoms.
Surgical treatment usually is reserved for people who have severe symptoms such as chronic GERD or a large hiatal hernia, a condition in which part of the stomach pushes upward through the diaphragm. Surgery is also an option for those who do not follow their recommended medical therapy or who want to avoid a lifetime of medical therapy.
How does it work?
The LINX system is composed of a series of titanium beads, each with a magnetic core, connected together with independent titanium wires to form a ring shape. It is implanted at the lower oesophageal sphincter, a circular band of muscle that closes the last few centimeters of the oesophagus and prevents the backward flow of stomach contents.
The force of the magnetic beads is designed to provide additional strength to keep a weak sphincter closed. Upon swallowing, the magnetic force between the beads is overcome by the higher pressures of swallowing forces, and the device expands to accommodate a normal swallow of food or liquid. Once the food passes though the lower oesophageal sphincter, the device returns to its resting state.
The company conducted a feasibility study of 44 patients at four centers with a five-year follow-up plan. In addition, the company conducted a pivotal study of 100 patients at 14 centers with a five-year follow-up plan. Patients enrolled had GERD and chronic GERD symptoms, despite medical therapy. Results from both the feasibility and pivotal trials indicate that the benefits obtained with the LINX Reflux Management System outweigh its risks.
Approval requires company to provide training
As a condition of approval, the company will institute a required training program to educate new users on patient selection, device implantation and post-procedural care of patients treated with LINX.
The most common adverse events experienced with the LINX included difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea.
It is important to note that patients with LINX will no longer be able to undergo Magnetic Resonance Imaging (MRI) procedures. The magnetic beads interfere with the machine and can cause the device to be damaged and the patient to be injured.
“The LINX Reflux Management System is a sterile, single-use, surgically placed device used to treat the symptoms associated with GERD,” said Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health. “LINX offers an option to patients and their health care providers and is an alternative to current surgical procedures.”
The full FDA press announcement can be found here.