A Study of Reflux Management With the LINX® System for Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

INCLUSION CRITERIA

Subjects included in the study must meet all the following criteria:

1. Age >22 years

2. Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device
implantation date.

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

4. Documented typical symptoms of GERD for longer than 6 months (regurgitation or
heartburn which is defined as a burning epigastric or substernal pain which responds
to acid neutralization or suppression).

5. Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.

6. 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, with the exception of antacids up to the morning of
testing.

7. Subjects with symptomatic improvement on PPI therapy demonstrated by a GERD-HRQL score
of <10 on PPI and >15 off PPI, or subjects with a >6 point improvement when comparing
their on PPI and off PPI GERD-HRQL scores.

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

9. 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.

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

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

EXCLUSION CRITERIA

Subjects should be excluded from the study based on the following criteria:

1. The procedure is an emergency procedure.

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

3. Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.

4. Subject had any major complications related to the laparoscopic sleeve gastrectomy
that may interfere with, or increase the risks of the LINX procedure (such as, but not
limited to, leaks from the gastric remnant and infection at the sleeve gastrectomy)

5. Plans to surgically revise the gastric pouch (either known preoperatively or decided
intraoperatively)

6. Currently being treated with another investigational drug or investigational device.

7. Suspected or confirmed esophageal or gastric cancer or prior gastric or esophageal
surgery or endoscopic intervention for GERD (with the exception of sleeve
gastrectomy).

8. Distal amplitude <35 mmHg or <70% peristaltic sequences (if using Conventional
Manometry). -or- If using High Resolution Manometry (exclude for any of the
following):

- Distal Contractile Integral (DCI) ≤ 450 mmHg·s·cm or

- ≥ 50% ineffective swallows or

- ≥ 50% fragmented swallows (Fragmented swallows are defined as those with a ≥ 5cm
break [large] in peristaltic integrity).

9. Presence of esophagitis - Grade C or D (LA Classification).

10. BMI >35.

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

12. Diagnosed with Scleroderma.

13. Diagnosed with an esophageal motility disorder such as but not limited to achalasia,
nutcracker esophagus, or diffuse esophageal spasm or hypertensive LES.

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

15. Subject has esophageal or gastric varices

16. History of/or known Barrett's esophagus. Note: The diagnosis of Barrett's esophagus
requires both endoscopic and histologic evidence of metaplastic columnar epithelium.
Endoscopically, there must be columnar epithelium within the esophagus.
Histologically, the epithelium must be metaplastic, as defined by the presence of
goblet cells.by

17. Subject cannot understand trial requirements or is unable to comply with follow-up
schedule

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

19. Any reason which the Investigator believes may cause the subject to be non-compliant
with or unable to meet the protocol requirements.

20. Subject has an electrical implant or metallic, abdominal implants.