Description

Overview

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level gastrostomy device for long-term enteral feeding, medication delivery, or gastric decompression in pediatric and adult patients. It features an inflatable internal retention balloon and a low-profile external base that sits at skin level. Initial placement may be performed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance; it is also suitable as a replacement tube for mature tracts.

Design and materials

• Low-profile button with external base designed to rest at skin level; proper fit typically leaves 1–2 mm clearance.
• Anti-reflux valve in the feeding port opens when a MIC-KEY extension set is attached to help minimize leakage when disconnected.
• Recessed, tapered distal tip; radiopaque stripe for visibility under imaging.
• High-clarity, medical-grade silicone; not made with natural rubber latex or DEHP.

Connectivity and extension sets

• ENFit (ISO 80369-3) connectivity with SECUR-LOK lock-and-key interface; use only MIC-KEY extension sets with the MIC-KEY port.
• Included 12 in (30 cm) extension sets:
• Continuous feed: right-angle SECUR-LOK, Y-connector with medication port, integrated clamp.
• Bolus feed: straight SECUR-LOK, ENFit connector, clamp.

Sizes and balloon

Available sizes

• French sizes: 12, 14, 16, 18, 20, 24 Fr.
• Stoma lengths (cm): 0.8, 1.0, 1.2, 1.5, 1.7, 2.0, 2.3, 2.5, 2.7, 3.0, 3.5, 4.0, 4.5, 5.0 (availability varies by size).

Balloon fill volumes

• Inflate with sterile or distilled water only; do not use air, saline, or contrast.
• 12 Fr: recommended 3 mL; maximum 5 mL.
• 14–24 Fr: recommended 5 mL; maximum 10 mL.

Sterility and reuse

• G-tube: sterile (ethylene oxide); single-use only; do not reuse or resterilize; do not use if package is damaged.
• Extension sets: non-sterile; reusable for a single patient; latex-free and DEHP-free.

Kit contents (typical ENFit configuration)

• MIC-KEY Low-Profile G-Tube (ENFit).
• Continuous feed extension set (12 in/30 cm) with Y-connector/medication port and clamp.
• Bolus feed extension set (12 in/30 cm) with clamp.
• 6 mL Luer slip syringe (balloon) and 35 mL ENFit enteral syringe.
• Gauze pad(s).
• Insertion stylet and water-soluble lubricant (in some regions).
• Patient use and care guide (per kit configuration).

MRI safety

MR Conditional at 1.5 T and 3 T (Normal Operating Mode). Under typical conditions (whole-body SAR < 2 W/kg), limited heating is expected; localized imaging artifact may occur near the device.

Indications and contraindications (summary)

• Indications: long-term enteral feeding in patients unable to meet needs orally; direct gastric medication delivery; gastric decompression; typically for patients at low aspiration risk.
• Contraindications (examples): ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity; clinician judgment required.

Handling notes

• Use only MIC-KEY extension sets; keep the SECUR-LOK engaged during feeding; disconnect by unlocking per IFU.
• Flush the tube and extension sets before and after use to help prevent clogging.
• Check balloon volume per clinician guidance; stabilize the button during inflation/deflation to avoid dislodgement.