A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy

Exclusion Criteria

• •1. Subjects undergoing:
• •1. Tonsillectomy as a result of cancer
• •2. Unilateral tonsillectomy
• •2. Subjects with:
• •1. Known Bleeding disorders
• •2. History of peritonsillar abscess
• •3. Craniofacial disorders
• •4. Down's syndrome (Trisomy 21)
• •5. Cerebral palsy
• •6. Major heart disease (including but not limited to; right-sided heart failure, left-sided heart failure, congestive heart failure, coronary artery disease, arrhythmias, chronic heart failure, acute heart failure, etc.)
• •7. Current tobacco use
• •3. Subjects unable to comply with the required study follow-up visits
• •4. Female subjects pregnant at time of procedure
• •5. The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
• •6. The subject is participating or has participated in any drug or device research study within 30 days of enrollment.