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The G-Tube is indicated for placement in adult populations that require enteral feeding, medication or gastric decompression through an established gastrointestinal stoma tract.

The Gastrostomy Feeding Tube (G-Tube) consists of two product versions (models): a Bi-Funnel G-Tube and a Tri-Funnel G-Tube. Each G-Tube version is offered in varying shaft French (FR) sizes and balloon sizes. Both versions are offered in the same functional length. The overall difference between the Bi-Funnel and Tri-Funnel G-Tube is that the Tri-Funnel G-Tube allows for simultaneous delivery of feeding solutions and medications while the Bi-Funnel G-Tube allows for delivery of either feeding solutions or medications at a time. Both Bi-Funnel and Tri-Funnel G-Tubes consist of a silicone funnel, shaft, adjustable external balloon. The funnel for the Bi-Funnel G-Tube has two ports: one port houses the balloon inflation valve which allows for balloon inflation and deflation, and the other port houses the male ENFit* connector (also known as PG Lock* connector) which allows for delivery of feeding solutions and medication. The Tri-Funnel G-Tube has three ports: one port houses the balloon inflation valve, the center port houses the male ENFit connector which allows for delivery of feeding solutions, and the last (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the connector when the device is in use. The same ENFit connector, tether and cap components are used for both Bi-Funnel and Tri-Funnel G-Tubes. The remaining components (shaft, adjustable bolster and balloon) are commonly shared for the Bi-Funnel and Tri-Funnel G-tubes and identical in both versions.

The EndoVive™ 3S Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive™ 3S Extension Set is intended to connect to a low profile balloon for enteral feeding, medication administration and gastric decompression. The EndoVive™ 3S Low Profile Balloon is indicated for use in adult and pediatric patients who require long term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach. The EndoVive™ 3S Extension Set is indicated for the delivery of nutrition, hydration and/or medication into the stomach through a low profile balloon and also provides a mechanism for gastric decompression.

The EndoVive™ 3S Low Profile Balloon Kit contains an EndoVive™ 3S Low Profile Balloon which is a sterile, low profile balloon gastrostomy tube. The kit also contains the following accessories which are intended to facilitate placement and use of the EndoVive™ 3S Low Profile Balloon: Continuous and Bolus feeding extension sets, a stiffener, transition adapters, syringes, lubricating jelly, gauze pads and a patient care bag. The EndoVive™ 3S Extension Sets will be sold separately in a non-sterile 5-pack configuration. The low profile gastrostomy tube is normally placed in a clinical setting and can be replaced and used in both a clinical and home care setting. The extension sets and syringes included with the kit may also be used in both a clinical and home care setting. Before using the EndoVive™ 3S Low Profile Balloon, the stoma tract must be measured and the tube size appropriate for the patient must be identified by the healthcare provider. The distal end of the tube is inserted through a gastrointestinal stoma tract and into the stomach. Then the balloon is inflated with sterile or distilled water. The fitment of the tube is verified by ensuring that the external bolster is flush against the abdomen. Extension sets are connected to the feeding port of the low profile gastrostomy tube to begin enteral administration and gastric decompression. The male ENFit connectors attached to the proposed devices are then connected to enteral sets and syringes incorporating female ENFit connectors. If enteral accessories incorporating female ENFit connectors are not available, the feeding port and medication port transition adapters may be connected to commonly available enteral administration sets and syringes. The male ENFit connectors attached to the EndoVive "" 3S Extension Sets were designed to reduce the likelihood of unwanted connections between enteral connectors. Until the ENFit connectors become widely available, the ENFit transition adapters will be provided with the EndoVive™ 3S Low Profile Balloon Kit to mitigate the risk of inaccessibility to care within the use environment. The general types of materials used for the proposed devices consist of silicones, thermoplastics and non-DEHP PVC materials.