Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level, balloon-retained G-tube that provides long-term enteral access for delivering nutrition and medications directly to the stomach and for gastric decompression. For enteral use only and intended for patients of all ages. Prescription use (Rx only).

Indications and contraindications

• Indications: Long-term enteral feeding in patients who cannot tolerate oral intake, are at low risk for aspiration, and/or require gastric decompression or direct medication delivery to the stomach.
• Contraindications: Ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity.

Placement and sizing

• May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement via an established stoma tract.
• Correct stoma length measurement is required; select a shaft length that matches the measured tract.

Design and key features

• Low-profile, skin-level “button” with external base, balloon valve, and ENFit extension-set port with port cover.
• Feeding port includes an anti-reflux valve that remains closed when no extension set is attached; do not insert a syringe directly into the feeding port.
• Recessed distal tip and radiopaque stripe for imaging confirmation.
• High-clarity, medical-grade silicone construction; sterile (ethylene oxide sterilized); not made with natural rubber latex.

Connectors and compatibility

• ENFit-only connections; intended for MIC-KEY ENFit Extension Sets, ENFit enteral syringes, and ENFit feeding administration sets.
• Use only MIC-KEY G extension sets with the MIC-KEY G feeding port. SECUR-LOK twist-to-lock mechanism helps reduce leaks and accidental disconnects; keep connections locked during feeding.
• Medication port: via the ENFit Y-connector on the continuous feed extension. Jejunal feeding port: not included (G-tube configuration).

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile Gastrostomy Feeding Tube.
• MIC-KEY Continuous Feed Extension Set, 12 in, ENFit, SECUR-LOK right-angle Y-connector with medication port and tubing clamp (non-sterile; single-patient reusable; not made with natural rubber latex; DEHP-free).
• MIC-KEY Bolus Feed Extension Set, 12 in, ENFit, SECUR-LOK straight connector (non-sterile; single-patient reusable; not made with natural rubber latex; DEHP-free).
• 6 mL Luer slip syringe (for balloon inflation/deflation) and 35 mL ENFit enteral syringe.
• Gauze pads. Not included: stoma measuring device. Note: some regional kits include an insertion stylet and water‑soluble lubricant.

Sizes and balloon fill (water only)

• French sizes: 12, 14, 16, 18, 20, 24 Fr; typical stoma lengths ~0.8–5.0 cm (size-dependent).
• Inflate balloon with sterile or distilled water only. 12 Fr: 3 mL (max 5 mL); 14–24 Fr: 5 mL (max 10 mL). Do not use air, saline, or contrast.

MRI safety

• MR Conditional at 1.5 T or 3 T in Normal Operating Mode (whole-body SAR < 2 W/kg). Expected temperature rise < 1.3 °C after 15 minutes; image artifact < 45 mm at 3 T (gradient echo). Refer to device labeling for the maximum spatial field gradient.

Use and care

• Single-use device; do not reuse, reprocess, or resterilize. Verify package integrity before use.
• Always attach an appropriate MIC-KEY ENFit extension set; do not insert syringes or feeding lines directly into the feeding port. Use only ENFit-compatible enteral accessories to avoid misconnections.
• Check balloon water volume weekly and replenish per IFU; silicone balloons typically last 1–8 months.
• Maintain patency by flushing through the extension set before and after use and at recommended intervals; avoid acidic irrigants.
• External base should rest slightly above the skin and the tube should rotate freely; consult a clinician if fit changes, rotation is restricted, or skin irritation occurs.