Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement

Inclusion Criteria

• •General information
• •The following patient categories can be recruited into this clinical investigation if they comply with all the selection criteria:
• •Patients recruited in the previous first-in-human (FIH) clinical investigation 2011CIP001
• •Patients with an open tracheostoma at the time of enrolment
• •Between 18 and 75 years old at the time of enrolment (i.e., informed consent form (ICF) signed)
• •Diagnosed with BVFP for a minimum of 6 months
• •With sufficient autonomous respiratory capacity to maintain their vital functions independently of the SPIRION Laryngeal Pacemaker. Before a permanent closure of the tracheostomy is carried out during this clinical investigation, the Principal Investigator shall confirm that at least at rest, the failure of the SPIRION Laryngeal Pacemaker would not put the patient in a life-threatening condition because of insufficient respiratory patency
• •At least one PCA responds to electrical stimulation (clear abduction of the respective VF in response to electrical stimulation) within an Endoscopic Cap Electrode (ECE50) test
• •Fluent in German.
• •Pregnant or breast-feeding women
• •Patients suffering from an ongoing or chronic laryngeal inflammation at the time of enrolment
• •Vocal fold immobility caused by arytenoid joint dysfunctions (e.g., arthritis, scarring, etc.), malignancies, central nervous system (CNS) pathologies, and/or systemic diseases
• •Patients who underwent previous permanent surgical glottal enlargement
• •Patients who underwent any other laryngeal surgeries (e.g., laryngeal framework surgery) that would compromise the correct SPIRION Electrode placement and/or the intended functionality of the SPIRION Laryngeal Pacemaker
• •The adductor laryngeal muscles on either or both sides underwent a botulinum toxin injection that is still effective at the time of surgery (i.e., the respective VF position is either in intermediate or lateral position)
• •Patients who underwent thoracic surgeries that would compromise at least one of the following procedures:
• •Correct placement of the SPIRION Electrode or SPIRION Implant
• •Connection of the SPIRION Implant with the SPIRION Electrode
• •Connection of the SPIRION Implant with the external SPIRION Processor
• •Patients wearing an active implantable medical device at the time of enrolment
• •Patients with a clinical history that would suggest a high probability that they would need an MRI
• •Patients diagnosed with a malignant disease in the head and neck region
• •Patients diagnosed with chronic airway infections or obstructions, or severe respiratory diseases (e.g., chronic obstructive pulmonary disease (COPD) grade II or higher)
• •Patients who underwent external beam radiation therapy in the surgical area
• •Patients diagnosed with a serious coagulation disorder requiring an uninterruptable use of anticoagulants
• •Patients with known allergies to the SPIRION Laryngeal Pacemaker material in direct contact with the human body
• •Patients suffering from moderate depression (Beck's Depression Inventory (BDI) ≥ 20) or any other psychological or psychiatric diseases
• •Any anatomic, physiological, or medical conditions that may increase the risks linked to the SPIRION Laryngeal Pacemaker implantation and/or reduce its benefit for the patient
• •Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of this clinical investigation
• •Anything that, in the opinion of the Principal Investigator, would place the patient at increased risk or preclude the patient's full compliance with the general requirements of this clinical investigation.