The Company, ENDALIS®, does not exercise any control over the conditions of use, the choice of patient, the implantation and extraction procedures used, the pressures placed upon the device and the handling of the device after sale.

The Company, ENDALIS®, cannot be held responsible for any damage, accidental or indirect, or for losses or costs resulting directly or indirectly from the use of this product.

There will be no reimbursement for any product explanted due to patient intolerance.

The explantation procedure of the ball requires specialized equipment.  The gastroenterologist must use the equipment recommended by ENDALIS®. No responsibility will be accepted by the Company, ENDALIS®, if different equipment is used.

The intra-gastric balloon is implanted for a maximum duration of 6 months. Any use for duration longer than that recommended will relieve ENDALIS®, of any responsibility.

Instructions for use