Overview
The GaBP Ring™ device is an annular restrictive ring placed around the surgically created pouch during a gastric bypass procedure to provide a stabilized pouch outlet.
Benefits of a Stabilized Pouch Outlet:
- Increases rate of success in more patients, especially the super obese.
- Reduces rate of gastric outlet problems at the anastomosis.
- Reduces need for revision operations.
- Limits complications associated with pouch outlet dilation,including inadequate weight loss, weight regain, GERD, dumping syndrome, and reactive hypoglycemia.
- Prefabricated, standardized and sterilized device that is ready to use and easy to implant!
Indications for Use
The GaBP Ring™ Autolock System includes the GaBP Ring™ device and the Gastrostomy Site Marker. The GaBP Ring™ device is an annular restrictive band intended to be placed during a gastric bypass procedure to limit the post-operation dilation of the gastric reservoir for improved maintenance of weight loss. The optional Gastrostomy Site Marker is intended to be placed onto the bypassed stomach to identify the location for possible future percutaneous placement of a gastrostomy tube.
Contraindications
The GaBP Ring™ Autolock is designed for use in bariatric surgery, with the creation of a restrictive pouch.
The GaBP Ring™ device may not be used on:
- Patients where gross infection or gross contamination is present
- Patients who are undergoing other treatment processes contraindicative to bariatric surgery; or
- Patients with severe psycho-emotional or medical problems that would make surgery unnecessarily risky
Precautions
The Surgeon must verify the compatibility of the GaBP Ring™ device with any other instruments to be used together in the surgical technique, prior to attempting band placement. Smooth jawed clamps should be used to handle the rubber areas of the GaBP Ring™ device.
Mechanical failure of the GaBP Ring™ device due to cutting, puncturing, or overstressing and subsequent separation at the damaged area may result in complications.
Periodic radiographic observations are recommended. If there is band erosion, the GaBP Ring™ device can be removed endoscopically.
The GaBP Ring™ Introducers should be removed from the patient, and documented.
Outlet stenosis can occur from an improperly sized GaBP Ring™ device.
It is the responsibility of the Surgeon to advise the patient of all potential risks and complications of the various procedures and devices.
Technology
The GaBP Ring™ device has a soft consistency that provides patients with comfort and safety. The device is radiopaque and made from implant grade silicone rubber. The ends have a plastic one-way locking mechanism that can be applied manually or laparoscopically. The device is reinforced with a monofilament core for strength and to help control food intake. The device is supplied with two silicone rubber tips, GaBP Ring™ Introducers, used to help feed the device into position around the physician created “pouch”. The GaBP Ring™ Autolock System also includes a circular flat radiopaque silicone disk called a Gastrostomy Site Marker that is placed on the bypassed stomach as a locator mark for future gastrostomy tube placement.