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...
Publication date: March 2019Source: Annals of Emergency Medicine, Volume 73, Issue 3Author(s): Ting-An Tung, Tou-Yuan Tsai
Publication date: March 2019Source: Annals of Emergency Medicine, Volume 73, Issue 3Author(s): Chih-Jen Yang, Chang-Chih Shih, Ching-Hsiang Lin
Publication date: March 2019Source: Annals of Emergency Medicine, Volume 73, Issue 3Author(s): M. Bryan Dalla Betta, Dasia Esener, J. Matthew Fields
Publication date: March 2019Source: Annals of Emergency Medicine, Volume 73, Issue 3Author(s): Heidi M. Goddard, Casey Z. MacVane, Tania D. Strout
Publication date: March 2019Source: Annals of Emergency Medicine, Volume 73, Issue 3Author(s): Po-Chen Chou, Shih-Chieh Chien
ConclusionImplementation of a HEART pathway in the ED evaluation of patients with chest pain resulted in less inpatient care and noninvasive cardiac testing and was safe. Using HEART to risk stratify chest pain patients can improve the efficiency and quality of care.
ConclusionAcute pain resolution after an ED visit seems to progress through 6 different trajectory patterns that are more informative than simple linear models and could be useful to adapt acute pain management in future research.
ConclusionA small proportion of ED patients discharged with nonspecific diagnoses of headache or back pain returned with a serious neurologic condition or inhospital death within 30 days.
ConclusionOur results showed that anxiety is highly related to TMD and we concluded that 62.8% of female dental students has anxiety of different levels.
Publication date: Available online 21 February 2019Source: The Saudi Dental JournalAuthor(s): Muneera Abdulaziz AlHassan, Ahmed Fathi AlOmar, Rana Saud AlShagroudAbstractBackgroundSalivary glands swellings are frequently encountered in the dental clinic. Their causes include but not limited to neoplasm, infection, stone, and inflammation. Sublingual salivary gland enlargements are commonly caused by ranula, while neoplasms rarely occur and if found they tend to be malignant. Another cause is idiopathic hyperplasia of the sublingual gland (IHSG), which is characterized as asymptomatic swelling of unknown cause, protrude fro...
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