Description

A low-profile, skin-level gastrostomy button designed for long-term enteral feeding, medication delivery, and gastric decompression in pediatric and adult patients. The internal water-inflated retention balloon secures the device, while the ENFit configuration supports current enteral connection standards via MIC-KEY extension sets.

Indications

• Patients who cannot tolerate oral feeding and require sustained enteral nutrition
• Direct gastric medication delivery
• Gastric decompression
• Suitable for patients at low risk for aspiration

Placement and Replacement

• May be placed percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance
• Usable as a replacement device through an established stoma tract

Connectors and Ports

• ENFit enteral standard via MIC-KEY extension sets
• Patient-end MIC-KEY SECUR-LOK connection designed to help reduce leaks and accidental disconnects
• Included extension sets: right‑angle continuous-feed Y-extension with medication port; straight bolus extension (each approx. 12 in)
• Jejunal port: none; Medication port: on the Y-extension

Key Features

• Low-profile, skin-level design for discretion and reduced interference with clothing
• Recessed distal tip and radiopaque stripe for visualization
• Feeding port with anti-reflux valve (opens when extension set is attached)
• Tubing clamp on extension sets

Materials and Biocompatibility

• High-clarity, medical-grade silicone
• Not made with natural rubber latex
• Not made with DEHP as a plasticizer

Retention Balloon

• Internal inflatable balloon; use sterile or distilled water only
• For 20 Fr: recommended fill 5 mL; maximum 10 mL

Sterility and Reuse

• Tube: sterile (EO sterilized); single-use only (do not resterilize or reuse)
• Extension sets: non-sterile; reusable for a single patient

Regulatory

• Prescription use (Rx Only)
• MR Conditional (see device IFU for specific MRI conditions)

Typical Kit Contents (ENFit configuration)

• Low-Profile Gastrostomy Feeding Tube
• Continuous-Feed Y-Extension with ENFit connectors and medication port (right‑angle, ~12 in)
• Bolus Extension with ENFit connectors (straight, ~12 in)
• 6 mL luer slip syringe (balloon inflation/deflation)
• 35 mL ENFit enteral syringe
• Gauze pad, insertion stylet, water‑soluble lubricant (availability may vary)

Sizes and Options

• French sizes: 12, 14, 16, 18, 20, 24 Fr
• Stoma lengths commonly 0.8–5.0 cm (availability varies by size)

Example Configuration

• 20 Fr outer diameter; 1.5 cm stoma length

Contraindications (non-exhaustive)

• Ascites, colonic interposition, portal hypertension, peritonitis, morbid obesity