Gastroenterology · Made in Germany

GERDX® System

A step between medication and surgery in gastroesophageal reflux disease (GERD): full-thickness plication (eFTP) from inside the stomach.

This page is intended for healthcare professionals.

GERDX System: Applicator and retroflexed instrument tip
Indication: GERD

Who is it for?

Patients with proven reflux who depend on a proton pump inhibitor (PPI) to keep their symptoms under control and who cannot take PPI long term or do not want lifelong medication, and are not surgical candidates yet.

The manufacturer describes the indication as GERD with a hiatal hernia of up to 3 cm that is not well controlled with medication, or where long-term medication is not an option. The randomised GERDX trials enrolled PPI-dependent patients; in the Gut 2022 trial their symptoms were controlled on PPI and most had non-erosive reflux disease. Patient selection decides the outcome.

The GERDX System creates a full-thickness plication (eFTP) at the gastroesophageal junction from inside the stomach, intended to rebuild the flap valve.

Dysfunctional gastroesophageal valve allowing reflux

Dysfunctional Valve

A weakened gastroesophageal junction lets gastric content reflux freely into the esophagus.

Functional gastroesophageal flap valve

Target: Functional Flap Valve

The plication is intended to rebuild the flap valve at the gastroesophageal junction.

0Incisions: the procedure is fully transoral
17.4 minMean procedure time, Gut 2022 randomised trial, n=70
Procedure

How is it performed?

Like a gastroscopy: under deep sedation or general anaesthesia, entirely from inside the stomach, under direct endoscopic view.

GERDX procedure: Introduction & Positioning
Retroflexed Applicator with opened arms at the gastric cardia
Step 01

Introduction & Positioning

The Applicator is introduced through the mouth and oesophagus over a guidewire, and an ultra-slim endoscope is passed through its scope channel. Under direct endoscopic view its front part is fully retroflexed, the arms are opened and the Tissue Retractor is advanced toward the gastric wall.

GERDX procedure: Tissue Retraction
Tissue Retractor drawing the gastric wall between the open arms
Step 02

Tissue Retraction

The Tissue Retractor is advanced deep into the gastric cardia; pulling it back draws the gastric wall between the open arms of the Applicator. The arm design and the centrally placed retractor gather a generous fold of tissue. Because the endoscope moves independently of the Applicator, the view is kept throughout.

GERDX procedure: Full-Thickness Plication
Arms closed: the full-thickness duplication takes shape
Step 03

Full-Thickness Plication

The arms are closed under view, creating a duplication through all layers of the stomach wall: endoscopic full-thickness plication, eFTP. The suture passes through every layer so that the fold holds, and the Applicator lets you reposition the Suture System before it is deployed permanently.

GERDX procedure: Suture Deployment & Removal
Deployed pledget suture holding the recreated tissue fold
Step 04

Suture Deployment & Removal

The pre-tied transmural pledget suture holds the full-thickness duplication at the gastroesophageal junction; wrapping the tissue this way is intended to rebuild the flap valve. The Tissue Retractor is removed, the arms are closed again, and the Applicator is straightened and withdrawn.

System

What does the system consist of?

Four components, ordered separately: the applicator, the suture system, the tissue retractor and the guide wire. An ultra-slim endoscope of at most 6 mm runs inside the applicator and moves independently of it.

GERDX Applicator

GERDX Applicator

A flexible instrument introduced over a guidewire, with the endoscope running inside its scope channel. Cables can only pull; the patented micro-hydraulic drive also pushes and holds, so tissue grasping, approximation and suture deployment come from one slim instrument.

GERDX Tissue Retractor

GERDX Tissue Retractor

Housed in the distal tip, stainless steel with a polycarbonate sheath. After the arms open, a rotating movement takes it into the muscle layer and pulls the wall between the arms for a true full-thickness bite; a movable sheath limits the depth.

GERDX Suture System

GERDX Suture System

A pre-tied transmural suture carried on the arms, non-resorbable, in two systems: a single filament polypropylene USP 2-0 and a multifilament polyester USP 0, pre-tied over titanium retention bridges. Two 10×6 mm ePTFE pledgets spread the contact pressure over the constantly moving stomach wall and are designed to keep the thread from cutting through.

Measurements at a glance

Endoscope outer diameter
≤ 6 mm
Endoscope length
≥ 100 cm
Bite block, inner size
≥ 22 × 18 mm
Suture spacing
≈ 0.5 cm
Implant materials

What stays in the body?

All three are long-established implant materials.

Suture: polypropylene USP 2-0 or polyester USP 0, depending on the suture system Retention bridges: titanium, grade 5 Pledgets: ePTFE, 10×6 mm
The difference

What changes for the patient and the unit?

  • Nothing is placed around the oesophagus The plication is made from inside the stomach: no dissection at the hiatus, no prosthesis; only suture, pledgets and retention bridges remain.
  • No procedure-related major event reported in the two randomised trials In both randomised sham-controlled GERDX trials: Gut 2022 (n=70) and Endoscopy 2023 (n=60).
  • What the scope must meet An ultra-slim endoscope of at most 6 mm outer diameter and at least 100 cm length runs inside the applicator's scope channel; the instructions name the Olympus GIF-XP190N or similar. A standard gastroscope places the guide wire first and checks the plication at the end. A latex-free bite block with an inner dimension of at least 22 by 18 mm completes the list.
Clinical evidence

What has been published?

Two randomised sham-controlled trials and five-year follow-up with the previous-generation device.

A physician holding the GERDX applicator and showing it to the team in an endoscopy room in Türkiye
GERDX in Türkiye

From first case to routine practice

Melekırmak Medical is the Türkiye distributor of G-SURG GmbH. eFTP depends on patient selection and a trained team, so we run the system as a programme. The system is in use in gastroenterology units in Türkiye today.

The programme is one we build with the manufacturer: the selection criteria gone through with your team before your first case, a proctor for your first patients, then field support.

Education & Workshops

Technical data

Manufacturer
G-SURG GmbH
Class
Is / IIa / IIb
SUT code
None
Sterilization
Sterile, for a single patient, not to be resterilized

Order items

ComponentClassShelf life (months)Order number
ApplicatorIs18 to 24255-000-01
Suture systemIIb24 to 36801-000-01
Suture systemIIb24802-000-01
Guide wireIs24 to 36810-000-01
Tissue retractorIIa24 to 36820-000-01

Sources: Gut 2022, Kalapala, n=70, Endoscopy 2023, Maydeo, n=60, Surgical Endoscopy 2008, Pleskow, n=33

If you are a patient or a relative: only a specialist in the relevant branch can judge whether this treatment fits you. Please ask your own physician.

Updated: 29.09.2026

Bringing a procedure to Türkiye

How we build a physician-to-physician programme around a new device.