Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device

Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device

The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures.

Inclusion Criteria:

• At least 18 years of age.
• Scheduled to undergo elective bariatric and/or hiatal hernia procedures.
• Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures.

Exclusion Criteria:

• Individuals with pacemakers, defibrillators, or other electromedical implants.
• Individuals with ferromagnetic implants.
• American Society of Anesthesiologists (ASA) score of III or IV.
• Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
• Clinical history of impaired coagulation confirmed by abnormal blood tests.
• Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.).
• Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use.
• Pregnant or wishes to become pregnant during the length of study participation.
• Individual is not likely to comply with the follow-up evaluation schedule.
• Participating in a clinical trial of another investigational drug or device.
• Prisoner or under incarceration.