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Product Name: ReShape Integrated Dual Balloon System
PMA Applicant: ReShape Medical, Inc.
Address: 100 Calle Iglesia, San Clemente, CA 92672
Approval Date: July 28, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140012a.pdf
The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
STIOLTO RESPIMAT (tiotropium bromide and olodaterol)
(sti-OL-to– RES peh mat)
Boehringer Ingelheim
Approval date: May 21, 2015
STIOLTO RESPIMAT is a long-term treatment for adults with a lung disease called COPD (chronic obstructive pulmonary disease). It is a combination of two drugs already used for COPD.
STIOLTO RESPIMAT should only be used to treat COPD and not for other breathing problems.
The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and 159,260 deaths in 2014. The most common type of lung cancer, NSCLC affects seven out of eight lung cancer patients, occurring when cancer forms in the cells of the lung.
Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. Opdivo is intended for patients who have previously been treated with platinum-based chemotherapy.
“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials.”
More than half of smokers with normal spirometry had some form of respiratory-related impairment associated with COPD, Dr. Elizabeth A. Regan and the Genetic Epidemiology of COPD (COPDGene) investigators reported in JAMA Internal Medicine.
The findings imply that up to 35 million current and former smokers older than age 55 years in the United States may have some form of respiratory-related impairment associated with COPD that has gone undiagnosed with standard spirometry, the researchers wrote (JAMA Internal Med. 2015 June 22 (doi:10.1001/jamainternmed.2015.2735).
They found that 55% of current and former smokers older than age 55 years in the study who did not meet the spirometric criteria for COPD (GOLD [Global Initiative for Chronic Obstructive Lung Disease] 0 score) had significant respiratory disease. Their conclusion was based on seven metrics: chronic bronchitis (seen in 12.6% of the GOLD 0 participants), history of severe respiratory exacerbations (seen in 4.3%), dyspnea score of at least 2 (seen in 23.5%), quantitative emphysema exceeding 5% (seen in 9.8%), quantitative gas trapping exceeding 20%, (seen in 12.2%), St. George’s Respiratory Questionnaire (SGRQ) total score exceeding 25 (seen in 26%), and a 6-minute walk distance of less than 350 m (seen in 15.4%).
FRIDAY, Feb. 20, 2015 (HealthDay News) — Contrary to what many people think, hookah water pipes do not filter out most of the heavy metals in tobacco, a new study warns.
Tobacco plants can absorb and accumulate heavy metals, such as copper, iron, chromium, lead and uranium. Long-term exposure to these heavy metals can increase smokers’ risk of head and neck cancers, as well as other diseases, the study authors said.
[Posted 02/19/2015]
AUDIENCE: Gastroenterology, Surgery, Nursing, Risk Manager, Biomedical Engineering, Patient
ISSUE: The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.
The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. In total, from January 2013 through December 2014, the FDA received 75 medical device reports encompassing approximately 135 patients in the United States relating to possible microbial transmission from reprocessed duodenoscopes. It is possible that not all cases have been reported to the FDA. The agency is continuing to evaluate information about documented and potential infections from multiple sources, including medical device reports submitted to the FDA, the medical literature, the health care community, professional medical societies, and the Centers for Disease Control and Prevention (CDC). The FDA is actively engaged with other government agencies, including CDC, and the manufacturers of duodenoscopes used in the United States to identify the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure.
http://www.nejm.org/doi/full/10.1056/NEJMoa1407764#t=abstract
Many studies have attempted to quantify the effect of obesity on death, fueling a sustained controversy about which levels of bodyweight can harm health.1 However, many investigators have argued that life expectancy does not capture the essence of the damage that obesity causes across a lifetime and that better long-term metrics are needed to convey risk, judge interventions, and motivate behaviour.2 In The Lancet Diabetes & Endocrinology, Steven Grover and colleagues3 model the effect of diabetes and cardiovascular disease in people who are overweight or obese and show what is intuitively known, but not often quantified, about obesity—that its effect on the number of number of healthy-years lost is far greater than its effect on total years of life.
DUE TO INCLEMENT WEATHER WE WILL BE CLOSED THURSDAY THROUGH SUNDAY
01/18/24 – 01/21/24