Introduction; Intended Use; Detailed Indications For Use; Device Description - Aspire Assist Manuel D'utilisation

1

Introduction

1.1

Intended Use

The AspireAssist Aspiration Therapy System is intended for
gastric drainage using a percutaneous endoscopic gastrostomy
(PEG) tube.

1.1.1 Detailed Indications for Use

The AspireAssist Aspiration Therapy System is intended to
provide gastric drainage for aspiration therapy to facilitate
weight reduction in morbidly obese adults (≥ 18 years) with a
Body Mass Index (BMI) of 35-65 kg/m
concurrently with a weight management support program.
Patients must have failed to lose weight or maintain long-term
weight loss with more conservative weight reduction
alternatives, such as diet, exercise and behavior modification
programs.
1.2

Device Description

1.2.1 System Overview

The AspireAssist consists of three parts:
1. A-Tube: a tube that is inserted through the belly and into
the stomach in an endoscopic (video camera in a tube
inserted down the esophagus and into the stomach)
medical procedure. The A-Tube connects the inside of the
stomach to the outside of the abdomen.
2. Skin-Port: a disc that sits slightly less than 1 cm above the
skin, attaches to the end of the A-Tube on the outside of the
abdomen, and controls the opening and closing of the

A-Tube.

3. Companion: a hand-held device that connects to the
Skin-Port, helps stomach contents flow more easily out of
the stomach through the A-Tube, and empties into a toilet.
The food emptying process is called Aspiration Therapy.
1.2.2 A-Tube
Skin-Port
Controlled entryway to the A-Tube that attaches to the
Connector and keeps the A-Tube in place.
Stoma Tract
The stoma is the opening in the belly. The tract is a channel
created between the skin and the stomach that surrounds the
A-Tube.
A-Tube Bumper
Dome-shaped rubber disc that sits against the stomach wall
and prevents the A-Tube from pulling-out of the stomach.
Stomach Tube
Tube with holes that drains stomach contents into the A-Tube.
4
, and must be used
2
Connector
attached to
Skin-Port
Companion
A-Tube
Bumper
Skin-Port
A-Tube™ (in stoma tract)
Connector Tube
Drain Tube (to
toilet or other
suitable
receptacle)
A-Tube™
(in stomach)