NewBreez Safety and Efficacy Evaluation

Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis

The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.

Inclusion Criteria:

1. Age > 18 years old
2. Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations
3. Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit
4. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: scanner, radiographic swallowing study, nasopharyngoscopy , NewBreez ILP implant as well as quality-of-life evaluation
5. Must be able to understand and be willing to provide written informed consent

Exclusion Criteria:

1. Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device
2. Major swallowing disorder
3. Existing coagulation disorder
4. Previous esophageal stenting
5. Life-expectancy < 12 months
6. Be pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential)Point of enrollment