Envoy wins FDA nod for MRI-conditional ear implant

AuntMinnie.com staff writers

Aug 7, 2018

Hearing device developer Envoy Medical has received U.S. Food and Drug Administration (FDA) approval for MRI-conditional labeling of its Esteem hearing implant.

The approval covers the use of the active middle-ear implant in both 1.5- and 3-tesla MRI environments, according to the company.

Representative longitudinal chest CT images and five-year parametric response mapping (PRM), pulmonary vascular CT reconstructions, and hyperpolarized xenon-129 (Xe-129) ventilation MRI scans from survivors of nonsevere and severe COVID-19 pneumonia. (A–F) Images in a 68-year-old male survivor of nonsevere COVID-19 pneumonia, (G–L) 62-year-old male survivor of severe COVID-19 pneumonia, and (M–R) 55-year-old male survivor of severe COVID-19 pneumonia. For each participant, the first three columns show coronal chest CT images from the acute phase (A, G, M), two-year follow-up (B, H, N), and five-year follow-up (C, I, O) (left to right). The fourth column (D, J, P) shows a coronal PRM image for each participant at five-year follow-up derived from paired inspiratory and expiratory CT scans, showing the spatial distribution of lung functional categories. Green indicates normal lung tissue, yellow indicates functional small airway disease, and red indicates emphysema. The second-to-last column shows volume-rendered small pulmonary vessel visualization (red) at five-year follow-up per participant (E, K, Q). The column on the far right (F, L, R) shows a hyperpolarized Xe-129 MRI ventilation defect percentage (VDP) map at five-year follow-up per participant. Dark blue represents high Xe-129 signal intensity, corresponding to well-ventilated lung regions, whereas red represents no Xe-129 signal intensity, corresponding to ventilation defects. At five-year follow-up, the 68-year-old survivor of nonsevere COVID-19 pneumonia (top row) showed near-complete radiologic resolution, no respiratory symptoms, and preserved pulmonary function. In contrast, the 62-year-old survivor of severe COVID-19 pneumonia (middle row) showed persistent fibrotic linear opacities without respiratory symptoms and mildly reduced pulmonary function. The 55-year-old survivor of severe COVID-19 pneumonia (bottom row) showed persistent scattered fibrotic linear opacities and focal emphysematous changes in both lungs, with dyspnea and impaired gas exchange function. The VDP values obtained from F, L, and R were 7.7%, 7.1%, and 6.3%, respectively.

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Representative MRI scans for which the independently assigned imaging-derived extranodal extension (iENE) grades differed among the readers. (A) Axial and sagittal images in a 56-year-old male patient with nasopharyngeal carcinoma and cervical nodal metastases. Readers 1 and 3 interpreted the finding as a metastatic lymph node invading the left sternocleidomastoid muscle (arrow) and assessed an iENE grade of 3, whereas reader 2 assigned a grade of 2. After joint review, the radiologists reached a consensus on the absence of definite sternocleidomastoid muscle invasion, and the final iENE grade was 2. (B) Axial and sagittal images in a 52-year-old male patient with nasopharyngeal carcinoma and cervical nodal metastases. Reader 1 interpreted the findings as a single enlarged metastatic lymph node and assessed an iENE grade of 1, whereas readers 2 and 3 interpreted them as two coalescent metastatic lymph nodes (arrows) and assessed a grade of 2. After joint review, the radiologists reached a consensus on the coalescence of the two metastatic lymph nodes, and the final iENE grade was 2.

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Representative longitudinal chest CT images and five-year parametric response mapping (PRM), pulmonary vascular CT reconstructions, and hyperpolarized xenon-129 (Xe-129) ventilation MRI scans from survivors of nonsevere and severe COVID-19 pneumonia. (A–F) Images in a 68-year-old male survivor of nonsevere COVID-19 pneumonia, (G–L) 62-year-old male survivor of severe COVID-19 pneumonia, and (M–R) 55-year-old male survivor of severe COVID-19 pneumonia. For each participant, the first three columns show coronal chest CT images from the acute phase (A, G, M), two-year follow-up (B, H, N), and five-year follow-up (C, I, O) (left to right). The fourth column (D, J, P) shows a coronal PRM image for each participant at five-year follow-up derived from paired inspiratory and expiratory CT scans, showing the spatial distribution of lung functional categories. Green indicates normal lung tissue, yellow indicates functional small airway disease, and red indicates emphysema. The second-to-last column shows volume-rendered small pulmonary vessel visualization (red) at five-year follow-up per participant (E, K, Q). The column on the far right (F, L, R) shows a hyperpolarized Xe-129 MRI ventilation defect percentage (VDP) map at five-year follow-up per participant. Dark blue represents high Xe-129 signal intensity, corresponding to well-ventilated lung regions, whereas red represents no Xe-129 signal intensity, corresponding to ventilation defects. At five-year follow-up, the 68-year-old survivor of nonsevere COVID-19 pneumonia (top row) showed near-complete radiologic resolution, no respiratory symptoms, and preserved pulmonary function. In contrast, the 62-year-old survivor of severe COVID-19 pneumonia (middle row) showed persistent fibrotic linear opacities without respiratory symptoms and mildly reduced pulmonary function. The 55-year-old survivor of severe COVID-19 pneumonia (bottom row) showed persistent scattered fibrotic linear opacities and focal emphysematous changes in both lungs, with dyspnea and impaired gas exchange function. The VDP values obtained from F, L, and R were 7.7%, 7.1%, and 6.3%, respectively.

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Representative MRI scans for which the independently assigned imaging-derived extranodal extension (iENE) grades differed among the readers. (A) Axial and sagittal images in a 56-year-old male patient with nasopharyngeal carcinoma and cervical nodal metastases. Readers 1 and 3 interpreted the finding as a metastatic lymph node invading the left sternocleidomastoid muscle (arrow) and assessed an iENE grade of 3, whereas reader 2 assigned a grade of 2. After joint review, the radiologists reached a consensus on the absence of definite sternocleidomastoid muscle invasion, and the final iENE grade was 2. (B) Axial and sagittal images in a 52-year-old male patient with nasopharyngeal carcinoma and cervical nodal metastases. Reader 1 interpreted the findings as a single enlarged metastatic lymph node and assessed an iENE grade of 1, whereas readers 2 and 3 interpreted them as two coalescent metastatic lymph nodes (arrows) and assessed a grade of 2. After joint review, the radiologists reached a consensus on the coalescence of the two metastatic lymph nodes, and the final iENE grade was 2.

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National and state neighborhood-level disadvantage rankings of the study patients. (A) National disadvantage rankings are shown. Left: area deprivation scores mapped onto the state of Wisconsin, where the study sample resides, with national ranking deciles shown. Blue indicates less disadvantaged neighborhoods, whereas red indicates more disadvantaged neighborhoods. Right: histogram quantifying the number of patients in each Area Deprivation Index (ADI) decile. (B) Same as A, but state ranking deciles are shown. The distributions of both the national and state-level ADI rankings of the patients were skewed toward less disadvantaged neighborhoods. Maps were obtained from reference 36.

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