Ethicon, a Johnson & Johnson MedTech company, has received label expansion approval from the US Food & Drug Administration (FDA) for its LINX Reflux Management System.
The LINX system is now approved for patients with Barrett’s oesophagus (BE) experiencing gastroesophageal reflux disease (GERD) symptoms.
The LINX Reflux Management System is a minimally invasive, fundic-sparing procedure designed to treat GERD.
It consists of a flexible ring of small magnets implanted around the lower oesophageal sphincter (LES). The strength of the magnets is calibrated to assist in keeping the weakened LES closed, thereby preventing reflux.
The LINX system was developed by Torax Medical, which was acquired by Ethicon in 2017.
Its latest approval is based on a retrospective review of a 2021 study, which demonstrated that LINX is both safe and effective in managing GERD symptoms in patients with BE.
Johnson & Johnson MedTech bariatric medical director Jörg Tomaszewski said: “We understand the urgency for patients with Barrett’s oesophagus experiencing gastroesophageal reflux disease to find relief from symptoms.
“This decision from the FDA to revise the labelling for LINX underscores Johnson & Johnson’s unwavering commitment to offering innovative solutions that safely and effectively serve as many patients as possible.”
According to Johnson & Johnson MedTech, the system offers an alternative to medications that control or suppress stomach acid to treat GERD.
In addition, the LINX Reflux Management System has shown its efficacy in treating GERD in both patients with and without BE.
Furthermore, a single-arm clinical trial found that 71% of BE patients who experienced GERD symptoms were able to stop relying on daily reflux medications after receiving the LINX treatment, the Johnson & Johnson MedTech claimed.
Study investigator John Lipham said: “The LINX Reflux Management System demonstrated remarkable efficacy at alleviating symptoms of gastroesophageal reflux disease in patients with Barrett’s oesophagus.
“With the opportunity to extend this treatment option to more patients with GERD, I am thrilled for patients to experience much-needed relief from this condition and experience improved quality of life.”
Johnson & Johnson MedTech, the medical technology division of Johnson & Johnson, introduced the Polyphonic platform in June.
Polyphonic is an open and secure digital ecosystem designed to enhance the surgical experience via improved connectivity.
