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/
The egg has been regarded as a symbol of new life and has been associated with springtime celebrations, such as Easter and Passover, for many centuries. But, even during festive occasions, eggs can cause food poisoning (also called foodborne illness). That’s why the U.S. Food and Drug Administration reminds consumers to follow safe food handling practices when buying, storing, preparing, and serving eggs or foods that contain them during their springtime celebrations and throughout the year.
To view the multimedia release go to:
http://www.multivu.com/players/English/7790251-fda-egg-safety/
The millions of women who experience bladder leakage now have a new option to strengthen and tone away their problem instead of covering it up with pads.
The PeriCoach System is a discreet device and smartphone app that helps women perform at-home pelvic floor muscle training, exercises recommended by the American College of Physicians as first-line treatment for urinary incontinence. PeriCoach is the only system that includes a web portal allowing clinicians to remotely monitor their patients’ progress.
To view the Multimedia News Release, go http://www.multivu.com/players/English/7543451-pericoach-fda-approval/
Nearly three in four American voters (74 percent) favor increasing federal funding for cancer research, according to the results of a new national survey conducted on behalf of the American Association for Cancer Research (AACR). The survey results were released today in conjunction with the AACR’s fifth annual Cancer Progress Report. The report highlights how federally funded research can power progress against cancer and urges Congress and the administration to implement a strategy for providing annual budget increases of at least 7 percent for the National Institutes of Health (NIH), National Cancer Institute (NCI), and U.S. Food and Drug Administration (FDA) in fiscal year 2016 and thereafter.
The national survey, which was conducted by Hart Research Associates and Public Opinion Strategies, shows that five out of every six voters recognize what the AACR Cancer Progress Report 2015 details: that progress is being made against cancer.
To view the multimedia release go to:
http://www.multivu.com/players/English/7613551-aacr-cancer-research-survey/
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/
1 in 3 women will notice hair thinning in her lifetime, and it can start as early as her 20’s. Today, the hair regrowth category leader, ROGAINE® Brand, announced the official launch to market of Women's ROGAINE® 5% Minoxidil Topical Aerosol, the first and only FDA-approved, once-daily use treatment for Female Pattern Hair Loss containing 5 percent minoxidil in an elegant foam formula. Minoxidil is the only topical ingredient FDA-approved to help regrow hair.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7368851-introducing-women-s-rogaine-5-percent-minoxidil-topical-aerosol-fda-approved/
EnteroMedics Inc. (NASDAQ: ETRM) today announced that the U.S. Food and Drug Administration (FDA) has approved VBLOC® vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years. The Maestro System is the first new medical device to be approved by the FDA for obesity in over ten years. EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year. The Maestro System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7269351-enteromedics-fda-approval-vbloc-maestro-system-weight-loss-device/
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/
Inspire Medical Systems, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Inspire Upper Airway Stimulation (UAS) therapy for use in a subset of patients with moderate to severe Obstructive Sleep Apnea (OSA) who are unable to use Continuous Positive Airway Pressure (CPAP). Inspire therapy is a fully implanted neurostimulation device, the first of its kind for sleep apnea, that provides an alternative treatment that is proven, convenient and easy to use.
To view the Multimedia News Release, go to: http://www.multivu.com/mnr/7169651-fda-approves-inspire-upper-airway-stimulation-therapy-sleep-apnea
Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease.
With this FDA approval, Boston Scientific will commence commercialization of the first and only BP-DES in the U.S. Notably, both the drug coating and the polymer – which modulates drug release – are fully absorbed shortly after drug elution is complete at three months.
The SYNERGY Stent provides synchronized drug and polymer absorption. It is designed to enable more rapid and complete arterial healing, and to thereby reduce the risk of complications associated with long-term polymer exposure compared to currently-used drug-eluting stents (DES) with permanent polymers.
To view the multimedia release go to:
http://www.multivu.com/players/English/7223456-boston-scientific-fda-approval-synergy/
Federally funded research that provides a deep understanding of cancer is spurring advances against many types of the disease. With a strong bipartisan commitment from Congress to keep investment in biomedical research a national priority, we can accelerate our pace of progress and save more lives from cancer, according to the seventh annual American Association for Cancer Research (AACR) Cancer Progress Report, released today.
Basic research in the fields of immunology and cancer genetics has recently been harnessed to develop two new forms of cancer treatment: immunotherapy and precision medicine. As detailed in the report, the utility of these treatments is expanding rapidly. In May 2017, the U.S. Food and Drug Administration (FDA) heralded a new dawn for precision medicine when it approved the immunotherapeutic pembrolizumab (Keytruda) for treating patients with any solid tumor harboring specific genetic characteristics. This is the first anticancer therapeutic approved based on cancer biomarkers rather than the location in the body where the cancer originated.
To view the multimedia release go to:
https://www.multivu.com/players/English/8155051-aacr-cancer-progress-report-2017/
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/
