Syncro Medical Innovations, Inc. was founded in Macon, Georgia in 1998. The first generation feeding tube (Magnaflow) utilized a hand held external magnet to steer the feeding tube into the distal duodenum. The feeding tube had a small magnet embedded at its distal end. The second generation feeding tube was enhanced by the addition of a magnetically activated sensor switch near the tube’s distal end and a light indicator at the proximal end. The third generation feeding tube (Syncro Blue Tube) was improved by re-locating the tube distal end magnets to the removable stylet.

Now in its fourth generation, the Gabriel® Feeding Tube with Balloon incorporates a small balloon at the tube’s distal end that allows the tube to advance post-pyloric via peristalsis. This eliminates the need for the external steering magnet and the tube's distal end magnet. Inflation of the balloon at mid-esophagus provides confirmation that the tube is inserted in the esophagus, not in the trachea, by observing no decline in pulse oximetry.

The Gabriel Feeding Tube with Balloon is available with ENFit® connector that is compliant with ISO 80963-3 standard. A convenience kit is provided with all needed accessories.

Gabriel® Feeding Tube with Balloon – New Critical Care Catheter

Development supported by:

DOD Award# W81XWH-09-2-0097

Identified problem:

Enteral feeding tubes historically have been associated with rare but serious complications.  Feeding tube misplacement in the lung, although rare (2%), is associated with high mortality rate (50%).  An ideal feeding tube should minimize tracheal misplacement and allow early gastric feeding with high potential for post-pyloric migration.  The Gabriel Feeding Tube with Balloon (GFTB) was developed by Dr. Sabry Gabriel with support from the United States Department of Defense to accomplish these goals.

Developed solution:

The GFTB has a balloon at its distal end.  It is inserted through the patient’s topically anesthetized nostril.  At the 30 cm depth mark (mid-esophagus), the balloon is inflated (using the syringe provided).  If the patient’s pulse oximetry does not drop, esophageal placement, rather than lung or tracheal placement, is confirmed within a few seconds. The tube is then advanced to the 70 cm mark, and the stiffening stylet is pulled out gradually as you advance more of the tube to the 100 cm mark. The stylet is removed and the tube is secured at the nose. The tube’s distal end balloon is deflated after 48 hours.

The tube wall is thin and flexible, but does not occlude by kinking, as it is reinforced with a spiral wire. This feature allows for placement of ample slack of the tube in the stomach and feeding without occlusion by kinking. Tube distal migration occurs by the natural effect of peristalsis on the bolus-sized balloon. The tube is packaged with a “convenience kit” that includes a numbing gel, applicator for the numbing gel, lubricant gel, syringe, skin adhesive and securing tape to save time during bedside placement.

Clinical validation:

During use in clinical practice, no misplacement of a tube in the lung or trachea has occurred so far.  This is a function of the effectiveness of the balloon as an early detection feature using the patient’s pulse oximetry.  Enteral feeding began immediately with the head of bed elevated 30 degrees once gastric placement was confirmed by X-ray.  The majority of the tubes placed in patients migrated post-pyloric within 12 to 24 hours by the effect of peristalsis on the balloon at the tube’s distal end.  It was observed that any nurse who can place an NG tube can easily place the GTFB with little (or no) additional training.

Benefits of enteral feeding are generally well known among clinicians. Whenever possible, post-pyloric feeding can provide an added advantage of reduced gastro-esophageal reflux aspiration type pneumonia. In that regard, the Gabriel Feeding Tube with Balloon offers more chance for distal tube migration than tubes without a balloon. It can also be used for gastric feeding. Because there is enough slack in the stomach, the tube has a significant chance to advance distally while tubes that are short and have less than 15 cm in the stomach will never advance distally.

When long conventional feeding tubes are inserted in the stomach, they tend to occlude by kinking. Therefore, it became common to use short NG tubes to feed when gastric suction is no longer needed. However, these short NG tubes will never advance distally even in patients with strong peristalsis.

 Reimbursement: CPT code 43761.