Indications, Safety and Warnings

The LINX® Reflux Management System is indicated for patients diagnosed with pathologic Gastroesophageal Reflux Disease (GORD) as defined by abnormal pH testing, and who continue to have chronic GORD symptoms despite maximum medical therapy.

The LINX Reflux Management System is labelled for use by physicians only.

Contraindications: Do not implant the LINX Reflux Management System in patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.

Warnings: The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T), depending on the LINX model implanted. Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. In the event alternative diagnostic procedures cannot be used and MRI is required, the LINX device can be safely removed utilizing a laparoscopic technique that does not compromise the option for traditional anti-reflux procedures.

Failure to secure the LINX device properly may result in its subsequent displacement and necessitate a second operation.

General Precautions: The LINX device is a long-term implant. Explant (removal) and replacement surgery may be indicated at any time. Management of adverse reactions may include removal and/or replacement.

The LINX device has not been evaluated in patients with a hiatal hernia larger than 3 cm. Use of LINX device in patients with a hiatal hernia larger than 3 cm should be considered on the basis of each patient’s medical history and severity of symptoms.

The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's oesophagus or Grade C or D (LA classification) oesophagitis.

The safety and effectiveness of the LINX device has not been evaluated in patients with electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants.

The safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions:

  • Scleroderma
  • Suspected or confirmed oesophageal or gastric cancer
  • Prior oesophageal or gastric surgery or endoscopic intervention
  • Distal oesophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or a known motility disorder such as achalasia, nutcracker oesophagus, and diffuse oesophageal spasm or hypertensive LOS
  • Symptoms of dysphagia more than once per week within the last 3 months
  • Oesophageal stricture or gross oesophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.)
  • Oesophageal or gastric varices
  • Lactating, pregnant or plan to become pregnant
  • Morbid obesity (BMI >35)

Potential Complications: Potential complications associated with the LINX Reflux Management System include achalasia (lower part of oesophagus does not relax), bleeding, death, device erosion (device passing through the oesophageal wall), device explant/re-operation, device failure, device migration (device does not appear to be at implant site), diarrhoea, dysphagia (difficulty swallowing), inability to belch or vomit, infection, impaired gastric motility, injury to the oesophagus, spleen, or stomach, nausea, odynophagia (painful swallowing), organ damage caused by device migration, pain, peritonitis (inflammation of the peritoneum), pneumothorax (collapsed lung), regurgitation, saliva/mucus build-up, stomach bloating, vomiting, and worsening of preoperative symptoms (including but not limited to dysphagia or heartburn).

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