A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.

Exclusion Criteria

• •1. Subjects undergoing cardiac and vascular procedures.
• •2. The procedure is an emergency procedure.
• •3. The procedure is a revision/reoperation of a primary operation..
• •4. Any female subject who is pregnant. 4a. Females of child-bearing potential will be required to undergo either a urine pregnancy test or serum pregnancy test during Screening and confirmed on the day of operation (except for subjects who are surgically sterile or are post-menopausal for at least two years) (USA only) and per EU local requirements.
• •5. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
• •6. The subject is unable or unwilling to comply with the study requirements or follow-up schedule.
• •7. The subject has comorbidities which, in the clinical judgment of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
• •8. The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment.
• •9. The subject is concurrently enrolled in another investigational drug or device research study or has been enrolled in another study within 30 days of enrollment.
• •10. Pre-existing/chronic conditions specific to Tri-Staple™ 2.0 Reload contraindications as described in the IFU.