Understanding Your Gastroesophageal Reflux Disease (GERD) Doc. No. 3595 Rev. 1 Understanding Your Gastroesophageal Reflux Disease (GERD)

GERD is caused by a weak sphincter muscle Doc. No. 3595 Rev. 1 Understanding GERD GERD, also called reflux, is a chronic, often progressive condition caused by a weak Lower Esophageal Sphincter (LES). The LES is a muscle at the junction of the esophagus and stomach that functions as the body’s natural barrier to reflux. In people with reflux, the LES is weak, allowing acid and bile to reflux from the stomach into the esophagus. GERD is caused by a weak sphincter muscle

GERD Symptoms Heartburn is the most common symptom of GERD. Doc. No. 3595 Rev. 1 GERD Symptoms Heartburn is the most common symptom of GERD. Other symptoms include: Regurgitation Sore throat Cough Chest pain Left untreated, GERD can lead to serious complications, including: Esophagitis Stricture Barrett’s esophagus Esophageal Cancer

GERD and Your Quality of Life Doc. No. 3595 Rev. 1 GERD and Your Quality of Life Reflux can also significantly impact quality of life. Patients with reflux disease often experience: Poor quality of sleep Reduced work productivity Dietary compromises to avoid symptoms Reflux patients may also have concerns about the long-term effects of reflux or the consequences of lifelong dependence on reflux medications.

Doc. No. 3595 Rev. 1 GERD and Medication Medications such as Nexium® or Prilosec®, are designed to control or suppress acid production in the stomach. These medications do not address the source of reflux and do not prevent reflux. Many patients on reflux medications experience symptoms, such as, regurgitation, respiratory complications and acid breakthrough.

The LINX® Reflux Management System Doc. No. 3595 Rev. 1 The LINX® Reflux Management System

LINX® Reflux Management System Doc. No. 3595 Rev. 1 LINX® Reflux Management System The LINX® System is designed to restore the body’s natural barrier to reflux. The LINX System consists of a series of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads augments the Lower Esophageal Sphincter (LES) to prevent reflux. Swallowing forces temporarily break the magnetic bond, allowing food and liquid to pass normally into the stomach.

LINX® Reflux Management System Doc. No. 3595 Rev. 1 LINX® Reflux Management System The LINX System helps keep the LES closed to prevent reflux The LINX System expands temporarily to allow for normal swallowing

Doc. No. 3595 Rev. 1 The LINX® Procedure

Doc. No. 3595 Rev. 1 LINX® Procedure The LINX System is placed around the esophagus just above the stomach by a trained surgeon. Standard minimally invasive laparoscopic approach Generally completed in less than 1 hour No alteration to gastric anatomy Reversible No post-operative adjustments

Post-operative Patient Care Doc. No. 3595 Rev. 1 Post-operative Patient Care

What To Expect After Surgery Doc. No. 3595 Rev. 1 Return to a normal diet as soon as tolerated Follow steps to manage dysphagia, if encountered Return to normal physical activity within a week Patients generally maintain ability to belch and vomit LINX Implant Card provided to all patients

Is the LINX® System Right for You? Doc. No. 3595 Rev. 1 Is the LINX® System Right for You?

Indication For Use FDA INDICATION Doc. No. 3595 Rev. 1 Indication For Use FDA INDICATION The LINX Reflux Management System is indicated for patients diagnosed with GERD, as defined by abnormal pH testing, who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux. 14

Frequently Asked Questions Doc. No. 3595 Rev. 1 Frequently Asked Questions

Frequently Asked Questions Doc. No. 3595 Rev. 1 Frequently Asked Questions Q. How is the LINX System implanted? A. The LINX System is implanted using a minimally invasive surgical technique called laparoscopy. This technique uses small incisions in the abdominal wall to access the area around the esophagus where the device will be placed.   Q. How long does the procedure last? A. The procedure usually lasts less than an hour, but each patient’s experience may differ. Q. When can I start eating normally again? A. Patients are encouraged to return to a normal diet as soon quickly as tolerated. This helps the body adapt to the LINX System. Q. When can I return to normal physical activities? A. Patients are generally able to return to non-strenuous activity within a couple of days. Q. Will I be able to belch or vomit with the LINX System? A. Patients who have received the LINX System have reported the ability to belch and vomit. Q. How long will the LINX System last? A. The LINX System is designed to be a life-long implant.  The cases and wires are constructed of titanium, which has a long history of use in permanent medical implants. The LINX System uses permanent magnets that are designed not to wear out. Q. Can I go through airport security? A. The LINX System should not affect airport security. All patients will be provided with an implant card to have available in the event an issue arises. Q. Will I be able to feel the LINX System after it has been implanted? A. A small number of patients have reported sensations in the area of the LINX System. It is not known if this is the device or the result of surgery in the area. These sensations have gone away over time. Q. Can I have an MRI? A. The LINX System is not considered safe for magnetic resonance imaging (MRI). You must avoid having a MRI test if you are treated with the LINX System. The MRI could cause serious injury to you and/or interfere with the magnetic strength and the function of the device. 16