The American Society for Aesthetic Plastic Surgery (ASAPS), is hosting a panel discussion about the latest best practices and uses for injectables including the newest FDA-approved options at The Aesthetic Meeting today in Montreal, Quebec Canada.
The panel discussed the latest advances, including the ways various dermal fillers can be utilized to produce optimal results for targeted areas. There are thirteen FDA-approved dermal fillers on the market to-date, providing aesthetic plastic surgeons with the ability to customize anti-aging treatments to patients’ needs. “The filler choices are dictated by a patient’s unique aging pattern, the anatomical area to be treated and physiochemical properties,” explains ASAPS member, Dr. Z. Paul Lorenc.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7310753-asaps-facial-rejuvenation-injectables/
The Eeva Test is now commercially available in the United States following its recent FDA clearance. This breakthrough technology is designed to help fertility clinics select the best embryos during in vitro fertilization (IVF) to aid in their effort to provide the best chance of a successful pregnancy.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7415751-the-eeva-test-by-auxogyn/
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the ClearSight system.
The ClearSight system is a noninvasive monitor that provides clinicians access to valuable blood volume and blood flow information for patients at moderate or high risk of post-surgical complications, in whom invasive monitoring would not be used.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7256451-edwards-fda-clearance-for-noninvasive-hemodynamic-monitoring-system/
For the millions who suffer from Gastroesophageal Reflux Disease (GERD), a study published today in the New England Journal of Medicine (NEJM) provides clinical evidence of safety and effectiveness for a new, FDA-approved medical device. Torax Medical’s LINX® Reflux Management System was studied in a controlled, prospective, multicenter trial involving 14 U.S. and European medical centers as part of the FDA pre-market approval process. The patients were evaluated before and after treatment to determine the effect of the LINX System on their GERD using pre-defined success criteria, which included reduction of esophageal acid, improvement in quality of life and elimination of reflux medications.
To view Multimedia News Release, go to http://www.multivu.com/mnr/60077-torax-medical-linx-reflux-management-system-clinical-study-published
A first-of-a-kind neural stem cell therapy that works with a common cold virus to seek out and attack a lethal and aggressive brain cancer is being tested at Northwestern Medicine in a Phase I clinical trial for patients newly diagnosed with malignant glioma.
The novel drug to treat malignant glioma, notorious for recurring after typical bouts of standard cancer treatment, was developed by a Northwestern scientist and has been approved as an investigational drug by the U.S. Food and Drug Administration. This is only the second time the University has supported and filed an investigational new drug as a sponsor.
To view the multimedia release go to:
https://www.multivu.com/players/English/7944251-northwestern-medicine-stem-cell-trial/
According to a national study released today, moms are feeling overwhelming pressure to overspend on products for their babies even as they significantly cut back in nearly every other area of their lives to cope with these challenging times.
To view Multimedia News Release, go to http://www.multivu.com/mnr/54418-kelton-research-mom-study-baby-products-store-brand-infant-formula
Novartis announced today that the US Food and Drug Administration (FDA) has approved Jadenu™ (deferasirox) tablets, a new oral formulation of Exjade® (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7440151-novartis-jadenu-fda-approval/
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/
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s antibacterial drug DIFICID™ (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older. CDAD is a significant medical problem in hospitals and long-term care facilities, and is beginning to emerge in the community among people previously at low risk for the disease. In the largest Phase 3 clinical studies ever conducted in CDAD, DIFICID had clinical response rates at the end of treatment that were non-inferior to oral vancomycin. DIFICID was superior to vancomycin in sustaining clinical response through 25 days beyond the end of treatment. DIFICID is the only FDA-approved antibacterial drug proven to be superior to vancomycin in sustained clinical response for CDAD.
To view Multimedia News Release, go to http://multivu.prnewswire.com/mnr/optimerpharma/50177/
Raptor Pharmaceutical Corp. (“Raptor” or the “Company”) (Nasdaq: RPTP), today announced that the U.S. Food and Drug Administration (FDA) has approved PROCYSBI™ (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. In a Phase 3 study, PROCYSBI showed consistent cystine depletion over the full 12-hour dosing period. Sustained levels of cysteamine have not historically been achieved in the majority of patients in this population. Studies have shown that sustained cystine depletion in patients may significantly delay disease progression, including kidney dysfunction, dialysis, kidney transplant, organ failure and premature death.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61338-raptor-pharmaceutical-procysbi-fda-approval-nephropathic-cystinosis
Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced FDA 510(k) clearance has been granted for the CorPath 200 System to be used in percutaneous coronary interventions (PCI). The technology is now approved in the United States to assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in patients with coronary artery disease (CAD).
“We are pleased to have received clearance from the FDA for the world’s first system designed for robotic-assisted PCI procedures,” said David M. Handler, President and CEO of Corindus Vascular Robotics. “This is an important milestone for interventional cardiology as we take the next step in transforming the way these procedures are performed in the future. The CorPath System offers hospitals the opportunity to bring robotic-assisted technology benefits to their coronary patients and their physicians.”
To view Multimedia News Release, go to http://www.multivu.com/mnr/57343-corindus-vascular-robotics-wins-fda-510k-clearance-for-corpath-200-system
Global biotherapeutics leader CSL Behring today announced that results were published in the New England Journal of Medicine (NEJM) from the COMPACT study, a pivotal Phase III study evaluating the safety and efficacy of CSL830 (a novel, investigational, self-administered, subcutaneous C1-Esterase Inhibitor [C1-INH] Human replacement therapy) for the prevention of HAE attacks. The study met its primary efficacy endpoint, significantly reducing the time-normalized number of HAE attacks. In addition, the study met its secondary endpoints, including the responder rate (patients who had at least a 50% reduction in their attack rate) and the number of rescue medication uses. If approved by the FDA, CSL830 would be the first and only subcutaneous preventative therapy for HAE.
To view the multimedia release go to:
https://www.multivu.com/players/English/8056151-csl-behring-subcutaneous-c1-esterase-inhibitor-hae-patients/
