LINX Reflux Management System Clinical Study Protocol

At present, the primary alternative for GERD patients with an incomplete symptomatic response
to proton-pump inhibitors (PPIs) is laparoscopic Nissen fundoplication. This surgical
procedure continues to be the prevalent non-medical treatment option for GERD patients,
despite several important limitations. First, it is a very traumatic procedure, requiring
portions of the stomach to be dissected and then wrapped around the tubular esophagus,
creating permanent anatomic alterations. Secondly, it can create significant side effects,
such as gas bloat syndrome, the inability to belch and the inability to vomit.

The intent of the LINX System is to allow a surgeon, using existing laparoscopic techniques
and instruments, to augment a weak LES and restore the defective barrier at the
gastroesophageal junction (GEJ). This defect of the GEJ is the source of abnormal reflux. The
LINX device is an expandable string of individual titanium beads with magnetic cores. The
device is laparoscopically placed as a ring around the lower esophageal sphincter. The
magnetic attraction of the beads augments the esophageal sphincter's ability to resist
gastric pressures that cause reflux. At rest, the LINX device encircles the sphincter with
each bead resting against an adjacent bead, to avoid compression of the tubular esophagus.
When swallowing, higher pressures are created, allowing the magnetic bond between beads to
break, and the LINX implant to expand radially. This serves to preserve swallow and other
physiologic functions, such as belching and vomiting, and avoids the side effect of
post-prandial bloating. The device can be placed with minimal dissection, preserving anatomy,
and is also removable, if necessary. This provides important benefits as it preserves the
native anatomy, unlike the Nissen procedure.

Inclusion Criteria:

- Subject must be at least 18 years of age and at least the minimum Age of Majority
according to applicable State or Country Law and must be less than 75 years of age,
with a life expectancy > 3 years

- Subject is a suitable surgical candidate, i.e. is able to undergo general anesthesia
and laparoscopic surgery

- Documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than
6 months (regurgitation or heartburn which is defined as a burning epigastic or
substernal pain which responds to acid neutralization or suppression)

- Patient requires daily proton pump inhibitor or other anti-reflux drug therapy

- Total Distal Ambulatory Esophageal pH must meet the following criteria: pH< 4 for ≥
4.5% of the time Note: Subjects shall have discontinued any GERD medications for at
least 7 days prior to testing.

- Subjects with symptomatic improvement on proton-pump inhibitor (PPI) therapy
demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on
proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6 point improvement
when comparing their on PPI and off PPI GERD-HRQL score

- GERD symptoms, in absence of PPI therapy (minimum 7 days)

- If the subject is of child bearing potential must have a negative pregnancy test
within one week prior to implant and must agree to use effective means of birth
control during the course of the study

- Subject is willing and able to cooperate with follow-up examinations

- Subject has been informed of the study procedures and the treatment and has signed an
informed consent form

Exclusion Criteria:

- The procedure is an emergency procedure

- Currently being treated with another investigational drug or investigational device

- History of gastroesophageal surgery, anti-reflux procedures, or
gastroesophageal/gastric cancer

- Any previous endoscopic anti-reflux intervention for GERD

- Suspected or confirmed esophageal or gastric cancer

- Any size hiatal hernia >3cm as determined by endoscopy

- Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg
peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences

- Esophagitis - Grade C or D (LA Classification)

- Body Mass Index (BMI)>35

- Symptoms of dysphagia more than once per week within the last 3 months.

- Diagnosed with Scleroderma

- Diagnosed with an esophageal motility disorder such as but not limited to Achalasia,
Nutcracker Esophagus, or Diffuse Esophageal Spasm or Hypertensive LES

- Subject has a history of or known esophageal stricture or gross esophageal anatomic
abnormalities (Schatzki's ring, obstructive lesions, etc.)

- Subject has esophageal or gastric varices

- Subject has history of or known Barrett's esophagus

- Cannot understand trial requirements or is unable to comply with follow-up schedule

- Pregnant or nursing, or plans to become pregnant during the course of the study

- Medical illness (i.e. congestive heart failure) that may cause the subject to be
non-compliant with or able to meet the protocol requirements or is associated with
limited life expectancy (i.e. less than 3 years)

- Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that
exhibit depression that are on appropriate medication(s) are allowable.

- Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials

- Subject has an electrical implant or metallic, abdominal implants