Search Results

The GT Metabolic MagDI™ System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GT Metabolic MagDI System is intended for use in adult patients > 21 years.

The set of two (2) Magnets is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis. After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.

The GT Metabolic MagDI System is intended for use in the creation of side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GT Metabolic MagDI System is intended for use in adult patients > 21years.

The set of two (2) Magnets is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis. After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.

The GT Metabolic MagDI System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GT Metabolic MagDI System is intended for use in adult patients > 21 vears.

The MagDI System is comprised of two (2) GT Metabolic DI Magnet ("Magnet") devices delivered sequentially with a minimally invasive GT Metabolic Delivery System ("Delivery System"). Class I magnetic surgical instruments (GT Metabolic Laparoscopic Positioning Device: FDA Listing #D512834) are used to position the Magnets to the target anastomosis locations in the duodenum and ileum and connect the two Magnets. The device provides a method for the creation of a round (oval/circular) compression anastomosis. After a period of approximately 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool. The MagDI System components (Magnets and Delivery System), as shown in Figures 1 and 2 below, are provided sterile and are for single use.

The Ez-HBT™ Helicobacter Blood Test is intended for use in the qualitative detection of 1302 in whole blood specimens, collected after the ingestion of 3C-urea. Helicobacter pylori (H. pylori) organisms colonizing the lining of the human stomach, produce urease which converts 13 C-urea into 13 CO2 and ammonia (NH4). The device is indicated as an aid in the diagnosis of H. pylori infection in symptomatic adult subjects, 18 years or older. For use by health care professionals. Administer test under a physician's supervision. Metabolic Solutions, Inc. or a qualified laboratory using Gas Isotope Ratio Mass Spectrometry or equivalent instrumentation must analyze the test samples.

Metabolic Solution's Ez-HBT Helicobacter Blood Test is based on the ability of H. pylori to produce the enzyme urease and convert urea to ammonia and carbon dioxide. By providing Helicosol (125 mg of 13C-labeled urea), the carbon dioxide produced by this reaction is carbon-13 labeled and an increase in the level of 1300 in the blood is an indication of the presence of H. pylori. The test requires a single blood sample, collected 30 minutes after ingestion of the drug. Subsequently, this blood sample is transported to a qualified laboratory. The CO, is evolved from the blood into the headspace of the Vacutainer tube and analyzed by gas isotope ratio mass spectrometry (GIRMS) to determine the 13CO .: 12O2 ratio. A diagnosis of H. pylori infection is based on the detection of blood 13CO, being greater than a cutoff value.