Medsil Intragastric Balloon
What is Intragastric Balloon?
Intragastric balloon is a relatively new medical device intended for effective body mass loss. It has become widely known during the recent years. It is used for obesity treatment and intended for the patient’s weight loss by means of partial filling of the stomach and, as a result, the absence of hunger. The set consists of a collapsed silicone balloon with a check valve, a silicone probe for the balloon placement with a silicone sheath, a metal guide wire for increased rigidity, a PVC tube for liquid transfusion.
How does it work?
Intragastric balloon is a spherical shell made of durable silicone with a check-valve attached to its wall, and a system of tubes for saline solution transfusion. The collapsed balloon is placed inside the stomach as a gastric probe, without any liquid inside. In the process of the balloon inflation with saline solution, the balloon becomes sphere-shaped. According to the initial volume of stomach, the size of the inflated balloon varies from 400 to 700 cc. When inside the stomach, the balloon fills the stomach excess capacity. Consequently, less food is needed to induce the reaction of receptors sending signals about the stomach filling. Thus, the patient feels satiety earlier than usual. With the course of time, the patient works out the habit to consume less food. Then the patient accustoms himself to the new diet and nutrition regime which is maintained for a long period after the balloon removal. The patient suffers from nausea, stomach overfilling, discomfort in the epigastrium area during the first several days after the balloon placement. But normally, within 7-14 days after intragastric balloon placement procedure, the patient almost doesn’t make notice of the device and lives the normal life style. The balloon is placed temporarily. The balloon can stay in the stomach for maximum 6 months and should be removed afterwards.
The advantages over other methods
• The balloon implantation procedure is not regarded as surgery. The balloon is implanted endoscopically which takes 10-15 minutes, under intravenous anesthesia;
• The procedure is tolerated easily by patients and can be compared with regular endoscopy;
• The patient doesn’t have to change his usual lifestyle;
• High efficiency;
• Minor risk of complications
Safety
The decision to use the balloon is made by a physician on the basis of the data obtained as a result of the total examination of a patient suffering from obesity. The balloon can be placed into the stomach of patients whose body mass index (BMI) is 30-40 kg/m2. Patients whose BMI is more than 40 kg/m2 can be treated with the balloon for the purpose of preparation for the surgery.
Certification
«MedSil» intragastric balloon has passed through the procedure of mandatory and voluntary GOST R certification. The device is approved for use throughout the territory of the Russian Federation and included in the National register of medical devices and equipment. The product has Registration certificate issued by the Federal Service for Supervision in the sphere of Health Care and Social Development of the Ministry of Health Care and Social Development of Russia. The company has adopted the Declaration of Conformity issued by an accredited certification authority — Certification agency for medical devices of polymeric materials and glass limited liability company «MEDPOLYMER-S».
«MedSil» intragastric balloon has passed toxicology test in the Testing Laboratory Center FGU NII FHM of the Federal Service for Supervision in the sphere of Health Care and Social Development.
In March 2017, certification audit of the factory was performed by Notified Body 3ЕС (№2265, the Slovak Republic). As a result of the audit, the conformity of the quality control system of CSC “MedSil” for design, development and distribution of non-0active medical devices “The set of silicone devices for gastric restriction” to the requirements of International standard EN ISO 13485:2012 was confirmed. The experts of the Notified body found that medical device “The set of silicone devices for gastric restriction” is manufactured according to the requirements of 93/42/ЕЕС Directive. Certificates were issued which authorize “MedSil” to mark the product with CE sign and distribute it on the territory of the European Union.