Description

The Avanos MIC-KEY Low-Profile Balloon Gastrostomy Button is a skin-level, balloon-retained feeding tube for long-term enteral nutrition, medication delivery, and/or gastric decompression in pediatric and adult patients. It may be initially placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or used as a replacement in a mature stoma tract. For enteral use only.

Key features and safety

• Low-profile, discreet “button” design minimizes snagging and interference with clothing.
• Internal inflatable silicone retention balloon; recessed/tapered distal tip and radiopaque stripe for placement verification.
• Anti-reflux valve in the feeding port; opens only via a MIC-KEY extension set (do not insert syringes directly into the button valve).
• SECUR-LOK patient-end interface with alignment marks for twist-to-lock security to help reduce leaks and accidental disconnects.
• High-clarity medical-grade silicone; not made with natural rubber latex or DEHP. Sterile, single-use (do not reuse, reprocess, or resterilize).
• MR Conditional at 1.5T and 3T: Normal Operating Mode whole-body SAR ≤ 2 W/kg; expected temperature rise < 1.3 °C after 15 min; image artifact < 45 mm on 3T gradient echo.

Connectivity and extension sets

• ENFit connectivity (ISO 80369-3) on the feeding side via extension sets; MIC-KEY SECUR-LOK at the patient end.
• Use only MIC-KEY extension sets with the MIC-KEY feeding port; remove the extension set between uses.
• Extension sets: right-angle SECUR-LOK design for continuous feeds (with optional Y-ports) and straight SECUR-LOK for bolus; ENFit connectors, swiveling/strain relief, non-sterile, reusable for a single patient, latex- and DEHP-free.

Kit contents (ENFit configuration)

• MIC-KEY Low-Profile Gastrostomy Button with ENFit-compatible port and balloon valve.
• Two ENFit extension sets (12 in/30 cm each): continuous feed (right-angle, Y-ports) and bolus (straight).
• 6 mL luer-slip syringe (balloon inflation/deflation) and 35 mL ENFit enteral syringe.
• Gauze pads (commonly 4). Insertion stylet and water-soluble lubricant included in some regions.

Sizes and balloon fill

• French sizes: 12, 14, 16, 18, 20, 24 Fr; stoma lengths (cm): 0.8–5.0 in discrete steps (24 Fr typically 1.5–5.0).
• Balloon inflation: 12 Fr—3 mL recommended (max 5 mL); 14–24 Fr—5 mL recommended (max 10 mL).
• Use sterile or distilled water only; do not use air, saline, or contrast.

Placement and care

• Attach extension set by aligning black marks, insert, then twist clockwise to lock; keep locked during use. Detach by turning counter-clockwise to re-align marks.
• External base should rest approximately 2–3 mm above the skin.
• Flush through the extension set before and after use and per care guidelines; periodically check balloon volume per the IFU.

Indications and contraindications

• Indicated for patients who cannot tolerate oral feeding, are at low aspiration risk, and/or require gastric decompression or direct gastric medication delivery.
• Contraindications include ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity (refer to IFU for complete list).

Materials and regulatory

• Tube: medical-grade silicone with barium sulfate radiopaque stripe; associated components may include engineering polymers per manufacturer.
• Sterilized with ethylene oxide (ETO). Prescription device (Rx only). Do not use if package is damaged; do not resterilize.
• CE marked; manufactured under an ISO 13485–compliant quality system. Typical shelf life: 2 years when stored cool and dry, away from heat/radiation.