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...
Source: Mass Device - Category: Medical Devices Authors: Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Pulmonx Source Type: news

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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]
Source: Journal of Ophthalmology - Category: Opthalmology Tags: J Ophthalmol Source Type: research
No abstract available
Source: Lippincott's Bone and Joint Newsletter - Category: Orthopaedics Tags: Trends and Innovations Source Type: news
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
Source: Spine - Category: Orthopaedics Tags: RANDOMIZED TRIAL Source Type: research
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Source: Spine - Category: Orthopaedics Tags: DEFORMITY Source Type: research
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Source: Spine - Category: Orthopaedics Tags: DEFORMITY Source Type: research
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Source: Spine - Category: Orthopaedics Tags: DEFORMITY Source Type: research
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...
Source: Spine - Category: Orthopaedics Tags: EPIDEMIOLOGY Source Type: research
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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...
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