Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale (PFO) can prevent recurrent ischemic strokes, W. L. Gore & Associates, Inc. (Gore) has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for its GORE® CARDIOFORM Septal Occluder. The device, already approved for closure of atrial septal defects (ASDs) up to 17 mm, is now also approved for the closure of PFO to reduce the risk of recurrent ischemic stroke in certain patients.*
To view the multimedia release go to:
https://www.multivu.com/players/English/8301551-gore-cardioform-septal-occluder-fda-approval/
Abbott today announced the U.S. Food and Drug Administration (FDA) approved the Masters HP™ 15mm rotatable mechanical heart valve, the world’s smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement. Until today, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, and larger valves are often not suitable given the smaller size of children’s hearts. This dime-sized new valve is the first and only pediatric mechanical heart valve developed for newborns and infants, and offers hope for pediatric patients in urgent need of treatment who have no other approved options.
To view the multimedia release go to:
https://www.multivu.com/players/English/8280551-abbott-pediatric-heart-valve-fda-approval/
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that its first doses of the Fluzone® (Influenza Vaccine) portfolio for the 2017-2018 influenza (“flu”) season have been released by the U.S. Food and Drug Administration (FDA). Sanofi Pasteur has begun distributing initial shipments, representing the first of nearly 70 million total doses of seasonal influenza vaccine manufactured by the company for this upcoming influenza season. Widespread shipment of Fluzone Quadrivalent, Fluzone High-Dose and Fluzone Intradermal Quadrivalent vaccine to health care provider offices, pharmacies and other immunizers will begin in early August to support fall immunization campaigns.
“As we enter the Swiftwater site’s 120th year, it reminds us of our innovation and growth as we came to understand the science of influenza and its impact on human health,” said David P. Greenberg, M.D., Associate Vice President and Regional Medical Head North America, Sanofi Pasteur. “Influenza can be especially severe for the most vulnerable populations, including the elderly, young children and those with compromised immune systems; however, it can also have a serious health impact on otherwise healthy individuals. Sanofi Pasteur is and always has been deeply committed to improving public health by continuously striving to develop new vaccines and on improving existing ones.”
To view the multimedia release go to:
https://www.multivu.com/players/English/8081151-sanofi-pasteur-influenza-vaccine-first-shipment-2017/
Dornier MedTech® America, a global medical device company and the pioneer of Extracorporeal Shock Wave Lithotripsy (ESWL®), has received FDA clearance to market the Delta® III. This is the latest generation of the world’s best-selling and most clinically cited lithotripter, the Delta II.
To view the multimedia release go to:
https://www.multivu.com/players/English/8134451-dornier-medtech-delta-iii-kidney-stone-lithotripter/
La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) alerta a las mujeres embarazadas sobre los riesgos de la listeriosis, una enfermedad transmitida por los alimentos que puede afectar gravemente a las mujeres embarazadas y a sus bebés no nacidos.
La Listeria puede afectar a personas de todas las razas y grupos étnicos, pero las mujeres embarazadas tienen una probabilidad aproximadamente 10 veces mayor de contraer listeriosis que otros adultos sanos debido a los cambios hormonales que afectan el sistema inmunológico durante el embarazo. Las mujeres hispanas embarazadas son unas 24 veces más propensas a contraer listeriosis que la población general. Una mujer embarazada puede transmitir la Listeria a su bebé no nacido incluso sin saberlo porque no se siente enferma, pero la enfermedad puede provocar un aborto espontáneo, muerte fetal, parto prematuro, nacimiento de un bebé con bajo peso, una amplia gama de problemas de salud para el recién nacido o incluso la muerte del bebé.
To view the multimedia release go to:
https://www.multivu.com/players/Spanish/7953451-fda-listeriosis-prevention-pregnant-women/
The U.S. Food and Drug Administration (FDA) is alerting pregnant women about the risks of listeriosis, a foodborne disease that can severely affect a pregnant women and her unborn child.
Listeria can affect all races and ethnic groups, but pregnant women are 10 times more likely than other healthy adults to get listeriosis due to hormonal changes that affect the immune system during pregnancy. Pregnant Hispanic women are about 24 times more likely than the general population to get listeriosis. A pregnant mother may pass Listeria onto her unborn baby without even knowing it because she doesn’t feel sick at all, yet the disease can lead to miscarriage, stillbirth, premature labor, the delivery of a low birthweight infant, a wide range of health problems for a newborn, or even infant death.
To view the multimedia release go to:
https://www.multivu.com/players/English/7953451-fda-listeriosis-prevention-pregnant-women/
The winter of 2016-2017 is in its early stages, and yet many parts of the country are already experiencing extreme weather conditions and power outages. In fact, a power outage can happen at any time, and it can affect the safety of your food. The U.S. Food and Drug Administration reminds you that the best way to ensure that food stays safe is to have a plan in place, and to know what food safety precautions to take if a power outage does occur.
To view the multimedia release go to:
http://www.multivu.com/players/English/7876851-fda-power-outage-food-safety-2016/
Studies show that more than two-thirds of aesthetically-oriented consumers are bothered by submental fullness, or “double chin.” And with social media profile images becoming more important than ever, there is interest in looking one’s best.
Submental fullness due to fat beneath the chin can impact a broad range of both men and women and because the condition can be genetic and resistant to diet and exercise. But there’s KYBELLA®, the first and only FDA-approved injectable treatment that is available by prescription only, that has been proven to improve the appearance of moderate to severe fat beneath the chin by physically destroying fat cells in the treatment area. In two pivotal clinical studies for KYBELLA®, reductions in submental fat volume were observed more frequently in the KYBELLA® treated group of 514 patients compared to the placebo group (508 patients) as measured by both clinician and patient ratings. In addition, visual and emotional impacts of submental fat (happy, bothered, self-conscious, embarrassed, looking older or overweight) were evaluated using a 6-question survey and 79% of 1 and 2-grade composite responders reported satisfaction after 12 weeks post final treatment compared with 33.6% of patients who received placebo.
To view the multimedia release go to:
http://www.multivu.com/players/English/7962051-kybella-injectable-double-chin-treatment-campaign/
October is National Seafood Month and a time to highlight the importance of fish and shellfish as part of a healthful diet. As with any food, safe handling of seafood is essential to reducing the risk of foodborne illness (often called food poisoning).
Learn more at:
http://www.fda.gov/Food/FoodborneIllnessContaminants/BuyStoreServeSafeFood/ucm077331.htm
Fresh and Frozen Seafood: Selecting and Serving it Safely
The U.S. Food and Drug Administration (FDA) reminds you to follow these basic safety tips for buying, storing, and preparing fish and shellfish.
To view the multimedia release go to:
http://www.multivu.com/players/English/7594351-fda-seafood-safety/
Federally funded research continues to spur progress against cancer; however, accelerating the pace of progress will require robust, sustained, and predictable annual funding increases for the National Institutes of Health (NIH), the National Cancer Institute (NCI), and the Food and Drug Administration (FDA). Additionally, strong financial support for the National Cancer Moonshot Initiative is required, according to the sixth annual American Association for Cancer Research (AACR) Cancer Progress Report, released today.
One of the most exciting new approaches to cancer treatment is cancer immunotherapy. As detailed in the report, the utility of immunotherapy is expanding rapidly. For example, on Aug. 1, 2015, one class of immunotherapeutics, checkpoint inhibitors, was initially approved for just two types of cancer—melanoma and lung cancer. As of Sept. 1, 2016, checkpoint inhibitors have been approved for treating six types of cancer—bladder cancer, head and neck cancer, Hodgkin lymphoma, kidney cancer, lung cancer, and melanoma.
To view the multimedia release go to:
http://www.multivu.com/players/English/7911951-aacr-2016-cancer-progress-report/
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announces today it has received U.S. Food and Drug Administration (FDA) approval for its newest innovative hearing loss solution, Kanso.
The Kanso Sound Processor provides a distinct new way for cochlear implant users to hear. Unlike most hearing aids and current cochlear implant sound processors that are worn on the ear, Kanso is a small, off-the-ear hearing device that provides a more discreet hearing solution and delivers the same hearing experience as a behind-the-ear sound processor.
The name Kanso is a Japanese word for ‘simplicity,’ and it was selected in recognition of Kanso’s all-in-one design. The Kanso Sound Processor features a single on/off button with no cables so it is easy to use. It is worn on the user’s head with nothing behind the ear, adding greater comfort for those with glasses, and it can be easily hidden under or blended within a user’s hair.
To view the multimedia release go to:
http://www.multivu.com/players/English/7658352-cochlear-kanso-fda-approval/
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that its first doses of Fluzone® (Influenza Vaccine) for the 2016-2017 influenza (“flu”) season have been released by the U.S. Food and Drug Administration (FDA) for shipment. This represents the first of more than 65 million total doses of seasonal influenza vaccine manufactured by Sanofi Pasteur that will be delivered to U.S. health care providers and pharmacies beginning in July and continuing throughout the remainder of the year. Sanofi Pasteur plans to increase its supply to respond to the shifting pediatric public health needs.
Seasonal influenza activity typically occurs between October and May and peaks between December and February. However, influenza activity peaked noticeably late last season occurring in early March 2016.1 Influenza seasons are always unpredictable as new influenza strains emerge and strain activity fluctuates throughout the year, making timely vaccination even more important to help protect against the virus, especially for seniors, young children and infants six months of age and older.
To view the multimedia release go to:
http://www.multivu.com/players/English/7842051-sanofi-pasteur-influenza-vaccine/
