Description

The MIC-KEY Low Profile Balloon Gastrostomy Feeding Tube, developed by Avanos, is a specialized medical device designed for patients requiring long-term enteral feeding. Suitable for both pediatric and adult patients, it provides a discreet and comfortable solution for those unable to tolerate oral feeding, offering direct delivery of nutrition, fluids, and medications into the stomach. Additionally, it serves as an effective tool for gastric decompression.

Design and Placement

This device features a low-profile, skin-level design, making it particularly suitable for active individuals and children. Its placement can be achieved percutaneously under fluoroscopic, laparoscopic, or endoscopic guidance, or as a replacement using an established stoma tract. The internal retention balloon, inflatable with sterile or distilled water, secures the tube within the stomach, while the external base rests slightly above the skin to minimize movement and support stoma development.

Key Features

• Anti-Reflux Valve: The feeding port is equipped with an anti-reflux valve to prevent backflow and leakage, enhancing patient comfort and safety.
• Atraumatic Tip: The recessed distal tip ensures gentle insertion and removal, reducing irritation to the stomach wall.
• Radiopaque Stripe: A radiopaque stripe allows for clear visualization during placement.
• Secure Connections: The extension set connector, available in ENFit or Catheter Tip, includes a secure locking mechanism with an audible double click for some models.

Material and Construction

Constructed from DEHP-free, latex-free medical-grade silicone or polyurethane, the MIC-KEY tube is a sterile, single-use device. Its robust design ensures compatibility with daily activities while maintaining high safety standards.

Configurations and Accessories

Available in various sizes, the tube offers outer diameters ranging from 10 to 24 French, with stoma lengths from 0.8 cm to 6.0 cm. Balloon fill volumes vary according to size, with specific configurations detailed in the Instructions for Use (IFU). The device is complemented by extension sets for continuous and bolus feeding, syringes for balloon management, and other essential accessories, often included in the kit.

Maintenance and Care

Proper maintenance involves daily cleaning of the tube and stoma site, regular flushing to prevent clogging, and periodic checking of balloon volume. Extension sets should be replaced regularly, and the device should not be reused or resterilized.

Safety and Compliance

The MIC-KEY tube is designed to prevent misconnections, complying with ENFit and ISO standards. It meets rigorous criteria for biocompatibility, sterilization, and radiopacity, and is FDA-cleared as a Class II medical device. For specific clinical use, users are advised to consult the official Instructions for Use and healthcare professionals.