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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ConclusionsImplementing the IMA was associated with significant reductions in VAP rates in intensive care units within Argentina.
Source: American Journal of Infection Control - Category: Infectious Diseases Source Type: research
Opioid use has reached epidemic proportions over the past decade, becoming one of America’s highest-priority public health issues. With opioid abuse spiraling out of control, lawmakers, regulators, and health professionals are scrambling to better understand key drivers of this issue and develop an effective action plan. Although the devastating impact of opioids on families and communities is well known, less focus has been given to how it affects the workplace and the role that employers and health care plan sponsors can play in combating it. Opioids’ impact on America’s workforce Opioid use is surging ...
Source: Kevin, M.D. - Medical Weblog - Category: General Medicine Authors: Tags: Policy Pain Management Public Health & Source Type: blogs
CONCLUSIONS: There is an urgent need for further research that can help guide clinical decision-making with patients who may not benefit from LCS owing to coexisting chronic illness. This statement establishes a research framework to address essential questions regarding how to incorporate and communicate risks of comorbidities into patient selection and decisions regarding LCS. PMID: 30004250 [PubMed - in process]
Source: American Journal of Respiratory and Critical Care Medicine - Category: Respiratory Medicine Authors: Tags: Am J Respir Crit Care Med Source Type: research
In conclusion, ET improves autonomic modulation in COPD with additional benefits for strength and cardiorespiratory capacity similar to conventional training. PMID: 30003108 [PubMed - in process]
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Conclusions: Patients with gynecomastia presented more often with aesthetic concerns and secondarily with breast pain. The most frequent final diagnosis was idiopathic gynecomastia, whereas the most frequent identified etiologies were anabolic steroids consumption, hypogonadism, and use of pharmaceutical drugs. Despite the low frequency of etiologies such as thyroid dysfunction or adrenal carcinoma, we emphasize the importance of a thorough assessment of the patient, as gynecomastia may be the tip of the iceberg for the diagnosis of treatable diseases. PMID: 30003107 [PubMed - in process]
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Conclusion: Leptospirosis is a common cause of undifferentiated tropical febrile illness in Colombia; it is important to establish ongoing and accurate surveillance for acute febrile illness to facilitate the detection of cases of leptospirosis. PMID: 30003104 [PubMed - in process]
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Publication date: Available online 27 June 2018Source: Clinical Lymphoma Myeloma and LeukemiaAuthor(s): Satoshi Ichikawa, Noriko Fukuhara, Yasushi Onishi, Ryo Ichinohasama, Hideo HarigaeAbstractA 53-year-old male suffering from fever, multiple skin nodules and gastric ulcer had been diagnosed as a rare and aggressive subtype of malignant lymphoma with a γδ T-cell phenotype. Cord blood transplantation was performed after achievement of a certain disease control by some courses of chemotherapy. Unfortunately lymphoma relapsed as early as two months after transplantation; however, it has been successfully and cont...
Source: Clinical Lymphoma Myeloma and Leukemia - Category: Cancer & Oncology Source Type: research
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Source: Medical Science Monitor - Category: Research Tags: Med Sci Monit Source Type: research
Conclusions: According to the previous studies, COPD patients with PE experienced an increased risk of death and prolonged length of hospital stay. Therefore, the thromboembolic risk in patients with acute exacerbation of COPD, especially in the hospitalized patients, should carefully be evaluated. PMID: 29998894 [PubMed - in process]
Source: Chinese Medical Journal - Category: General Medicine Authors: Tags: Chin Med J (Engl) Source Type: research
McDonald’s salads may be to blame for a parasitic illness outbreak that has sickened more than 100 people in Illinois and Iowa, according to public health officials. Since mid-May, Illinois alone has seen more than 100 cases of cyclosporiasis, an intestinal illness caused by the parasite cyclospora, according to an announcement from the Illinois Department of Public Health. Iowa is experiencing a similar outbreak, according to a statement from the Iowa Department of Public Health. McDonald’s salads may be the culprit in both states, according to the announcements. Twenty-nine people in Illinois and at least 15 ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized healthytime onetime public health Source Type: news
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