Laryngeal Pacing Study

Inclusion Criteria: * Male or female adult patients, 22 years of age or older * Diagnosis of bilateral vocal fold paralysis, at least one year prior to study enrollment * Must have tracheostomy in place minimum of 6 weeks prior to implantation of St.Jude Medical Infinity™ IPG device * Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles * Demonstrated peak inspiratory flow with respiratory testing through the mouth of at least 0.4 L/sec Exclusion Criteria: * Any active illness that is associated with an immune disorder (such as diabetes) * History of cardiac dysrhythmias or implanted cardiac pacemaker * Any electronic implanted medical device that, in the investigator's opinion, could interact with the laryngeal pacemaker * Active cardiac disease manifested by unstable angina, recent myocardial infarction, malignant arrhythmias, uncontrolled hypertension (diastolic greater than 110), or decompensated congestive heart failure * Patients with underlying comorbidities that, in the investigator's opinion, could potentially warrant a need for oxygen therapy, including but not limited to: Chronic obstructive pulmonary disease, asthma, emphysema, recurrent bronchitis, pneumonia or interstitial lung disease * Bilateral laryngeal immobility from stenosis or arthritis * Poor Surgical risk patients as determined by the treating surgeon or Vanderbilt Preoperative Evaluation Center (VPEC) * Patients with acute or chronic infe…