Pulmonx wins FDA approval for Zephyr endobronchial valve
The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema. Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The Zephyr device is designed to decrease the volume of the chest to improve function in the heart, respiratory muscles and healthy lung tissue. Inserted via bronchoscopy, the pencil-eraser-sized valves prevent air from entering the diseased alveoli but allow it to escape during exhalation. The federal safety watchdog said it granted Zephyr’s PMA based on a 190-patient study comparing treatment with Zephyr, plus standard medical management and pulmonary rehabilitation, to treatment with standard medical management and rehab only. The trial’s benchmark was at least a 15% improvement in pulmonary function score. Some 47.7% of patients in the Zephyr arm met that mark, compared with 16.8% of the control arm, according to the FDA. Adverse events included death, pneumothorax, pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain, the agency said. “Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These have included lung surgery, such as lung volume reduc...
Conclusion: New onset HSK after keratoplasty primarily resulted in epithelial and stromal lesion, involving both the graft and recipient. Effective treatments included antiviral medications and amniotic membrane transplantation. Delayed treatment may lead to aggravated graft opacification. PMID: 30425853 [PubMed]
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Conclusion. For patients with symptomatic DS, patients who received surgery had significantly greater improvements in pain and function compared with nonoperative treatment through 8 years of follow-up. Fusion technique did not affect outcomes. Level of Evidence: 1
Study Design. Prospective single center study. Objective. The aim of this study was to evaluate 1) the activity of daily living (ADL) of three categorized patients group; over 60-year-old degenerative spine patients without adult spinal deformity (ASD), nonoperative ASD patients, and operative ASD patients, 2) what kinds of activities would be impaired, and 3) how the ADL changes over time after long level fusion. Summary of Background Data. There is still debate how surgeons could decide treatment methods for old-aged adult spinal deformity, operatively or not. There was lack of information how long level fusion i...
Conclusion. Great L3 and L4 tilt at skeletal maturity, especially those>16°, are predictors of future curve progression and LBP in adulthood, respectively. For adolescent patients with these risk factors, periodic follow-ups into adulthood should be considered. Level of Evidence: 4
Conclusion. This study demonstrates a strong correlation between neuromuscular gait parameters and fear-avoidance of movement which may reflect ADS patient experiences during ambulation. Further, it demonstrates that there are different aspects of fear-avoidance that may influence gait parameters. This study extends previous research on the role of fear-avoidance to include patients with spinal deformity. Level of Evidence: 3
Study Design. Community-based, cohort study. Objective. Our aim was to determine the course of back pain in middle-aged women over a 9-year period, and assess whether obesity and physical inactivity are associated with more frequent back pain. Summary of Background Data. Back pain is the leading cause of disability worldwide. With minimal effective therapies and rising financial burden, identifying modifiable risk factors remains a key priority. Methods. The Australian Longitudinal Study on Women's Health is a cohort study of community-based, middle-aged women who completed questionnaires every 3 years between 2...
Conclusion. A positive Hoffman alone is unlikely to lead to more than a small change in estimated probability of DCM as compared with the gold standard test (magnetic resonance imaging). Variability in results across individual studies may result from differences in study design. There are insufficient data to support use of the Hoffman sign alone to confirm or refute a diagnosis of DCM. Level of Evidence: 1
Authors: Taniguchi H, Nakanishi Y, Tsuda T, Masaki Y, Furuse H, Suzuki K, Ishizawa S, Muto A, Shimizu M, Ichikawa T, Miyazawa H Abstract OBJECTIVE: Many patients with a chief complaint of chest tightness are examined in medical facilities, and a lack of diagnosis is not uncommon. We have reported that these patients often include those with chest tightness relieved with bronchodilator use (CTRB) and those with chest tightness relieved with the use of asthma drugs except bronchodilators (CTRAEB). The purpose of this study was to demonstrate the clinical characteristics of the patients with CTRAEB and compare them wi...
CONCLUSIONS: Neurosurgeons showed good compliance with legal requirements, except in the matter of calling for the opinion of an external consultant. Furthermore, this survey confirmed variability in the use of prognosis predictors, and the need for further clinical research so as to achieve more-standardized practices to minimise the subjectivity in decision-making. PMID: 30424955 [PubMed - as supplied by publisher]
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