Regulatory, Medical & Safety Information
Transparency, safety, and responsible use
Complete regulatory, safety, and medical information for GASTER control® — a CE-marked abdominal support medical device with controlled external compression.
Regulatory classification and manufacturer
5/1 Merchants Street, Valletta VLT 1171, Malta
Destination of use and scope
The device is intended for support of the abdominal wall in the following indications:
Abdominal hypotonia. Post-operative support of the abdominal wall (under medical prescription). Support during recovery after abdominal surgery. Limitation of abdominal pressures during daily activities.
The device integrates a localized abdominal compression system via inflatable balloon. The use of this compression function must strictly comply with the contraindications, precautions, and instructions for use described below.
When the device must not be used
- Pregnancy
- Patient under 18 years of age
- Morbid obesity (BMI > 40)
- Irreducible or non-fitted abdominal hernia
- Immediate post-operative period without medical advice
- Severe gastro-esophageal reflux, gastric ulcer, or active digestive pathology
- Cardio-respiratory or neurological conditions potentially aggravated by abdominal compression
- Diagnosed eating disorders
- Dermatoses or skin lesions at the belt area
- Any medical condition potentially worsened by abdominal compression (including suspected abdominal aortic aneurysm)
Safe use guidelines
- Verify the integrity of the device before each use
- Wear the belt over a thin garment — never directly on skin
- Inflate the balloon progressively — never seek maximum compression. Maintain moderate, comfortable pressure. Stop immediately in case of pain, dyspnea, nausea, dizziness, or discomfort
- Do not use the device with the balloon inflated in a lying or semi-reclined position
- Do not use while driving a vehicle
- Do not use during intense physical activity or sudden movements
- Take regular breaks to avoid prolonged compression
- In case of redness, irritation, swelling, sensory disturbance, or unusual skin reaction, remove the belt immediately and consult a healthcare professional
- The presence of ferromagnetic components makes the device incompatible with MRI
- Keep the belt and accessories out of reach of children
- Consult a healthcare professional if in doubt about using the compression function
Possible side effects
Abdominal discomfort. Mild respiratory constraint. Skin redness or irritation. Gastric reflux in sensitive individuals.
If any of these symptoms occur, remove the device immediately.
Engineering principles for safe use
Safety is integrated throughout the design, development, and validation process. The risk management file is developed in accordance with EN ISO 14971:2019 and covers all hazardous situations under normal and abnormal conditions of use.
Risk reduction
Following the implementation of risk control measures, overall risk was reduced by approximately 56%. All intolerable risks were eliminated. Residual risks are documented and assessed as acceptable relative to the clinical benefits.
Biocompatibility
All components in contact with or adjacent to skin are evaluated per ISO 10993-1 for prolonged intact-skin contact. Key biological endpoints addressed include cytotoxicity (ISO 10993-5), sensitization, and irritation (ISO 10993-10). The device is designed to be worn over a garment, minimizing direct skin contact.
Mechanical validation
Performance testing includes inflation/deflation cycle durability, elastic band tension testing, auto-grip fastening strength, and mechanical wear assessment of pump and balloon assemblies. Real-time ageing studies and use tests complement the validation program.
Current evidence status
Preliminary observational data in real-life conditions suggest consistent trends including facilitation of satiety perception, reduction in portion sizes, improvement in eating behavior regulation, and good overall tolerance. These findings are exploratory and remain under further clinical evaluation.
A multicentric observational registry (GC-REG-01) is currently underway to generate structured data in routine clinical practice. These results do not constitute definitive proof of efficacy and require confirmation through controlled studies.
Cleaning, storage, and traceability
Cleaning
Hand wash at 30°C maximum with mild soap. Rinse thoroughly and dry flat at room temperature. Do not use solvents, alcohol, bleach, or abrasive detergents. Do not iron, machine dry, or tumble dry. Allow to air dry flat.
Storage
Store between 10°C and 30°C. Keep away from humidity, heat, dust, and direct sunlight.
Traceability and vigilance
Retain the device reference and lot number for all correspondence. In case of an incident or serious adverse effect related to device use, immediately inform the manufacturer and/or the competent authority in your country (in France: ANSM).
Proprietary technology
GASTER control® and related biomechanical designs, including the Extra-Parietal Balloon (BEP™) technology, compressive shield architecture, and associated engineering principles, are proprietary. Patent filed and completed in France, with an IP strategy designed to support international extensions.
Unauthorized reproduction, imitation, or use of protected elements is prohibited.
Conditions of use and limitations of liability
GASTER control® shall not be held responsible for use inconsistent with the Instructions for Use, misuse or inappropriate adaptation of the technology, or use outside applicable professional, clinical, or regulatory frameworks.
Technical specifications, intended use statements, and regulatory information may evolve over time in accordance with product development, jurisdictional requirements, and clinical validation pathways.
The content provided on this website is for informational and educational purposes only. It does not constitute medical advice and should not replace professional medical evaluation or clinical decision-making. Individual responses may vary. Any clinical observations presented are exploratory and should not be interpreted as guaranteed outcomes.
CE-marked medical device. Class I — EU MDR 2017/745. Proprietary biomechanical design (patent pending).
Always refer to the full Instructions for Use supplied with the device.