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The Low Profile Non-Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma.

The Low Profile Non-Balloon Feeding Device is used to provide nutrition, medication, and decompression access into the stomach through a secured (initial placement) or formed (replacement) stoma. The device may be placed using one of two insertion methods including an 'obturator' insertion method and a 'capsule' insertion method. Capsule Insertion Method: The internal bolster of the device is encased by water dissolvable capsule. The capsule technology provides a low-profile option that is delivered by lubricating the capsule with lubricant, inserting the device through the stoma site, and pulling on a pull tab that pulls a suture through the capsule and deploys the internal dome. Once the capsule is deployed, the internal dome returns to its uncompressed shape and the device is held in place. Obturator Insertion Method: A T-Handle and ratcheting obturator rod (Snap Arm Assembly) is used to extend the internal dome, decreasing the outer profile of the dome. When the dome is fully elongated, the internal dome maintains a narrow profile that can easily be inserted into the stoma site with proper lubrication. Once inserted into the stoma site, the ratcheting rod and T-handle are removed and device is held in place by the internal bolster. Once placed, both devices provide access to nutrition, medication, and decompression into the stomach via a Mini ONE® feeding port. Both devices are identical after placement regardless of the insertion method chosen. Removal of feeding device can be performed by using a removal tool assembly (Snap Arm and T-handle with removal tool reinforcer). Removal is done by elongating the internal bolster to reduce the outer diameter of the dome, providing for an easier removal process. The Low Profile Non-Balloon Feeding Device will be offered in several different diameters including14 Fr, 18 Fr, 20 Fr, and 24 Fr and will be available in stoma lengths ranging from 1.0 cm to 4.4 cm. The Low Profile Non-Balloon Feeding Device is provided sterile for single use only. The molded body of the Non-Balloon feeding device is made of medical silicone. The Low Profile Non-Balloon Feeding Device consists of an external bolster, feeding catheter, and internal retention bolster similar to the predicate devices. The external bolster consists of a feeding port for access to the stomach through the tubing of the device and a strap with a plug to close the feeding port while not in use. In addition, an anti-reflux valve is included in the feeding port area to prevent backflow of stomach contents while not in use. The feeding catheter is inserted into the stomach through a stoma and is held in place with the internal retention bolster. There are two different insertion methods for the proposed device, the 'capsule' and the 'obturator' method. The 'capsule' version includes a tapered capsule enclosing the internal bolster at one end that allows ease of insertion and an obturator rod is pre-loaded in to the shaft prior to use. The 'obturator' version uses a T-Handle and snap arm assembly for controlled insertion and elongation through the device shaft. The Low Profile Non-Balloon Feeding Device and the predicate devices are provided in a number of sizes to accommodate different stoma diameters and lengths.