INDICATIONS FOR USE:
The RESET® System is indicated for the management of morbid obesity in adult patients with BMI ≥40 kg/m2 or patients with BMI ≥30 kg/m2 with at least one concurrent cardiometabolic risk factor, e.g. type 2 diabetes or dyslipidemia.
IMPORTANT SAFETY INFORMATION:
RESET is approved for use under the EU MDR, but is for investigational use only in the US. For a complete list of precautions, Warnings and Contraindications and summary of clinical performance please see the product IFU and/or SSCP at www.reset-therapy.com/patientinformation.
PRECAUTIONS AND WARNINGS:
Pre-procedural precautions
- Please do not take anticoagulants (aspirin, heparin, NSAIDs, etc.) for 10 days prior to RESET® Liner placement and for the duration of treatment.
- Individuals with known allergies or hypersensitivity to ceftriaxone, cephalosporins or penicillins should seek an equivalent, long-acting, broad-spectrum antibiotic. Please see antibiotic package insert for full prescribing information and details.
- Please take an over-the-counter H2-receptor antagonist, 40mg/BID from two-weeks prior to when the RESET® Liner is implanted to two weeks after the RESET® Liner is explanted.
Post-procedural Precautions
- Immediately contact the doctor in case of fever, shivering, or pain to ensure that the patient is treated in due time in case of a hepatic abscess.
- Daily monitoring of the body temperature is recommended to identify any potential infection resulting in hepatic abscess.
- Certain foods (such as seeds and nuts) or lack of adequate hydration can interfere with the proper functioning of the RESET® Liner. Therefore, do not eat seeds and nuts and follow the diet regimen outlined by your physician. If a soft food diet is not applied,
- Food could shift the device, causing bleeding.
- The Delivery System Deployment Ball is left in the body and passes naturally, without need for retrieval, within 24 hours.
MRI INFORMATION
The RESET Liner is made of a nitinol type material and has a small metal component at the opening of the device. Both components can be used with MRI when precautions described in the Instructions For Use are taken.
IMPLANT DURATION
The RESET® Liner is intended for an implant duration of 9 months.
SPECIAL OPERATING INSTRUCTIONS
Only physicians trained in therapeutic endoscopic techniques should use this product.