Description

Overview

A low-profile, balloon-retained gastrostomy device for long-term enteral access, the Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button provides gastric feeding, medication delivery, and decompression. This validated variant is 16 Fr with a 2.7 cm stoma length and is gastric-only (no jejunal port). It is intended for enteral use only and features ENFit connectivity on the feeding side.

Indications and Contraindications

• Indications: Patients unable to tolerate oral feeding, at low risk for aspiration, and/or requiring gastric decompression or direct gastric medication delivery.
• Contraindications (non-exhaustive): Ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity.

Placement and Use

May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, and is also intended as a replacement device via an established stoma tract.

Key Design Features

• Low-profile, skin-level button with external base and balloon retention.
• Feeding port with anti-reflux valve that remains closed when no extension set is attached.
• Tapered, recessed distal tip at recommended fill volume.
• Radiopaque stripe for visualization.
• High-clarity, medical-grade silicone construction.

Connectivity and Compatibility

• ENFit connectivity (enteral-only) on the feeding side.
• MIC-KEY SECUR-LOK connector with alignment marks and quarter-turn lock.
• Use only MIC-KEY extension sets; do not connect to non-enteral systems.

Included Components (ENFit)

• MIC-KEY Low-Profile G-tube (button).
• 35 mL ENFit enteral syringe.
• 6 mL Luer slip syringe for balloon inflation/deflation.
• Gauze pads (4).
• Insertion stylet (US only).
• Water-soluble lubricant (US only).
• Extension sets: 12 in/30 cm continuous-feed (right-angle patient-end, Y-connector with medication port, clamp) and 12 in/30 cm bolus (straight patient-end, clamp).
• Extension sets are non-sterile, reusable for a single patient; not made with natural rubber latex; DEHP-free.
• Stoma measuring device not included.

Balloon and Sizing

• 16 Fr device: recommended balloon fill 5 mL (maximum 10 mL). Use sterile/distilled water only; do not use air, saline, or contrast.
• Family sizes: 12, 14, 16, 18, 20, 24 Fr; stoma lengths typically 0.8–5.0 cm (2.7 cm validated for this variant).
• Typical silicone balloon life 1–8 months; check balloon water volume periodically (e.g., weekly).

Materials and Sterility

• Tube: medical-grade silicone with radiopaque (barium sulfate) stripe.
• Button: single-use, sterile, EO-sterilized; do not reuse or re-sterilize; do not use if package is damaged.
• Extension sets: non-sterile; reusable for a single patient.
• Not made with natural rubber latex; not made with DEHP as a plasticizer.

MRI Safety

MR Conditional at 1.5 T and 3 T; maximum spatial field gradient ≤ 19.6 T/m; whole-body averaged SAR < 2 W/kg (Normal Operating Mode). Expected maximum temperature rise < 1.3 °C after 15 minutes; image artifact typically < 45 mm at 3 T with GRE.

Additional Notes

Enteral-only device. Maintain patency with appropriate flushing per IFU.