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No pharmaceuticals. No surgery.
When patients suffer from chronic gastroesophageal reflux disease (GERD) that is not well controlled with medications, or where long-term medications are not an option, the procedure of an endoscopic full-thickness plication (eFTP) performed with the GERDX-System could be an alternative.
The GERDX-System bridges the big treatment gap between medication and more invasive surgical solutions by being less invasive, having fewer adverse effects and without limiting future treatment options.
The GERDX-Procedure is a minimally invasive treatment for patients with gastroesophageal reflux disease (GERD) and a hiatal hernia up to 3cm.
Similar to a gastroscopy, the procedure is performed from inside the patient`s stomach under direct endoscopic visualisation.
Achieving similar clinical outcomes as the more well known surgical procedures, the GERDX-System is less invasive and has far fewer adverse events, all without limiting future treatment options.
The incisionless procedure is performed from inside the patient´s stomach under deep sedation or general anesthesia. By use of a flexible endoscope and a guidewire, the Applicator can be gently introduced into the stomach via mouth and esophagus. Under visualization of the endoscope, the front part of the Applicator is fully retroflexed, the arms opened and the Tissue Retractor is advanced into the tissue.
The Tissue Retractor is advanced deep into the gastric cardia mucosa and by pulling back, the gastric wall is retracted into the open arms of the Applicator. Due to the design of the manipulating arms and the central positioned Tissue Retractor a lot of tissue can be gathered for the subsequent suturing process.
As the integrated endoscope can be navigated independently from the Applicator, a perfect visualization is given within the whole procedure.
The arms of the Applicator are closed under visualization, creating a full-thickness duplication (eFTP, endoscopic full-tickness plication) through all layers of the stomach wall. Suturing through all layers of the stomach wall is highly important as this forms the basis for a durable outcome. Due to this fact the design of the Applicator allows easy repositioning of the Suture System before deploying it permanently.
The Suture System has been deployed, the Tissue Retractor removed and the arms of the Applicator re-opened again. The pre-tied transmural pledget suture ensures a full-thickness duplication and a tight closure of the gastro-esophageal junction around the shaft of the Applicator. In addition to this the natural flap-valve is recreated again by wrapping the tissue. Afterwards the arms are closed again, the Applicator straightened and removed from the patient.
The underlying functional principle of the GERDX-System is called endoscopic full-thickness plication (eFTP). Many studies and publications have been made available to the public showing a high level of safety and efficiency.
Since then many adaptions and further developments have been made with the GERDX®-System. By use of the patented micro-hydraulic system all disadvantages of cable-driven, flexible instruments have been eliminated. The micro-hydraulic system allows highest precision and force transmission in every situation.
During the development of the GERDX-System, emphasis was placed on a straight forward usability, enabling the physician to focus on the patient rather than on the technology.
All parts of the GERDX-System are supplied as sterile, single-use products.
Traditional flexible endoscopic technologies rely on cables to drive the systems, however cables can only be pulled, and are very limited with the amount of force that can be transferred.
Micro-Hydraulics allow for the application of exceptionally high force and precision, required for tissue grasping and approximation, as well as the firing of surgical technologies for suturing and stapling.
Minimum space is required for the Micro-Hydraulic system which enables the reduction in size of the technology, and makes it more flexible, and less invasive for insertion into the patient.
The GERDX-Tissue Retractor is located inside the distal tip of the GERDX-Applicator.
After opening the arms of the GERDX-Applicator the GERDX-Tissue Retractor can be moved towards the target tissue.
Through a rotational movement, the GERDX-Tissue Retractor drills into the muscle layer of the stomach wall, pulls it between the arms of the Applicator and thus enables a subsequent full-thickness suturing.
A movable sheath prevents a too deep penetration into the stomach wall.
The arms of the GERDX-Applicator are equipped with the GERDX-Suture System. Depending on the application, different Suture Systems can be used.
In order to ensure a long durability of the GERDX-Sutures System in the extremely active stomach tissue, the filament is reinforced on both sides with ePTFE pledgets.
Due to the large surface of these pledgets (10x6mm), the contact pressure is reduced and evenly spread. This effectively prevents migration of the filament through the stomach.
Permanent remaining parts
To allow a durable fixation of the tissue in this highly active region of the human body ePTFE-pledgets are used to reinforce the surgical sutures. The big surface of the ePTFE-pledgets (10x6mm) reduce the load on the tissue and thereby mimimize the risk of migration. This is the basis for a durable and safe solution.
All materials are tested on their biocompatability and in use for many years within daily surgery:
surgical suture: braided PET, USP 0
anchors: titanium, grade 5
A different non-invasive approach, compared to surgery or a lifelong pharmaceutical therapy:
- brief intervention time (avg. 20min)
- short hospitalization
- alternative treatment options remain
Many clinical data on the procedure of eFTP (endoscopic Full-Thickness Plication) have been published within the last 15 years.
As the procedure showed a high level of safety and efficiency the GERDX-System was designed to perform eFTP.
In addition to the clinical data published for the GERDX-System and the procedure of eFTP, the GERDX-System is regularly presented within congresses and other medias.
Live-Procedure shown during the worlds largest virtual endoscopy meeting "Endoscopy on Air".
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Report on TV regarding GERDX-Procedures performed in the UAE.
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Report on TV regarding the first GERDX-Procedure performed within the UK.
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We combined already established gold-standard procedures with our patented micro-hydaulic technology to archive minimally invasive gastroenterologic procedures.
In close cooperation with physicians, this leads to highly innovative products used internationally.
We focus on:
Treatment of gastroesophageal reflux disease (GERD)
Resection of gastro intestinal stroma tumors (GIST)
Incisionsless bariatric procedures (EWL)