Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved the Tecnis Symfony® Intraocular Lenses for the treatment of cataracts. The first in a new category of intraocular lenses (IOLs), the Tecnis Symfony lenses are the only lenses in the United States that provide a full range of continuous high-quality vision following cataract surgery, while also mitigating the effects of presbyopia by helping people focus on near objects. The FDA approval includes a version of the lens for people with astigmatism, the Tecnis Symfony Toric IOL.
Cataracts are a common condition, with almost 4 million cataract surgeries performed each year, and that number is expected to increase.1 By age 80, more than half of all Americans either have a cataract or have had cataract surgery.2 However, cataracts do not just impact seniors. In 2016 it is estimated that nearly one in four cataract surgeries will be performed on people younger than 65.1 Many people who have cataracts experience other problems with their vision, such as presbyopia and astigmatism, which the Symfony lenses also address. Presbyopia, which affects most people over age 40, means people have lost the ability to focus on objects up close and often require glasses to perform near visual tasks. Astigmatism is when the cornea is misshapen, which causes blurry or distorted vision.
To view the multimedia release go to:
http://www.multivu.com/players/English/7870151-abbott-intraocular-lenses/
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/
Following FDA approval of the AspireSR® generator for the VNS Therapy® system in June 2015, more than a thousand patients with drug-resistant epilepsy across the United States have received this new treatment option. Many of these patients are experiencing benefits which have positively impacted their lives – and are sharing their stories during Epilepsy Awareness Month with the hope of encouraging others to seek new treatments for drug-resistant epilepsy. Numerous hospitals nationwide have begun providing the AspireSR device to patients with drug-resistant epilepsy – a condition that affects as many as one-third of people with epilepsy, causing them to have seizures in spite of treatment with antiepileptic medications.
The VNS Therapy system is a minimally invasive option in which a medical device is placed under the skin in the upper chest area during an outpatient procedure. The device sends mild electrical pulses through the vagus nerve to areas of the brain known to be associated with seizures. The new AspireSR generator takes the VNS Therapy technology a step further – detecting relative heart-rate increases that are often associated with seizures in people with epilepsy and providing responsive stimulation in an attempt to stop and shorten seizures and improve recovery.
To view the multimedia release go to:
http://www.multivu.com/players/English/7651751-livanova-aspiresr-treatment/
In a revolutionary treatment for early-onset scoliosis (EOS), a team of surgeons implanted adjustable growing rods in two children from California. The pioneering surgeries — the first ever in the United States — were performed on May 7th at Rady Children’s Hospital in San Diego. The Food and Drug Administration (FDA) granted Compassionate Use approval to use the MAGEC™ (MAGnetic Expansion Control) System, developed by Ellipse Technologies, Inc., for these two patients.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61604-rady-children-s-hospital-san-diego-ellipse-magec-early-onset-scoliosis-eos
The USPSTF today issued a draft recommendation giving its second highest approval rating for CT screening for lung cancer for those at high risk, a move that if approved in final form, will trigger Medicare and insurance coverage and bring about a dramatic drop in the leading cause of cancer deaths.
Today, LCA also launched its Risk Navigator tool – www.AtRiskForLungCancer.org. Additionally, it expanded the hours of its support line – (800) 298-2436 – operating 8 a.m. to 7 p.m. EST. LCA will also launch a national educational advertising campaign in September to encourage the public to know their risk for lung cancer.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/62719-lung-cancer-alliance-uspstf-recommends-ct-screening-for-lung-cancer
Boston Scientific Corporation (NYSE:BSX) announces U.S. Food and Drug Administration (FDA) approval for the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, the Company’s next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent, designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with the market-leading everolimus drug. The Company plans to begin marketing the product in the U.S. immediately.
To view Multimedia News Release, go to http://www.multivu.com/mnr/43510-boston-scientific-fda-promus-element-plus-platinum-chromium-stent-system
Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business, announces the FDA clearance of the pocket-sized PICO◊ system, a single use Negative Pressure Wound Therapy (NPWT) system. PICO is cleared for use both in a hospital and homecare setting and expands the use of NPWT from the traditional wound care population to include a wider range of patients undergoing orthopaedic surgery, plastic surgery and general surgical procedures. This FDA clearance follows the recent successful launch of PICO in Europe, Canada, and Australia.
To view Multimedia News Release, go to http://www.multivu.com/mnr/51011-smith-nephew-pico-system-fda-approval-npwt
Today, Novo Nordisk announced new phase 3 interim data from its guardianTM2 trial for its recombinant coagulation factor VIII (rFVIII) product NovoEight® (turoctocog alfa), the first new rFVIII molecule in over a decade, which shows that it provides long-term reduction from bleeding in people with haemophilia A when used as a preventative treatment.1 The results were presented at the World Federation of Haemophilia (WFH) World Congress and support findings from other studies within the guardianTM clinical programme that found NovoEight® demonstrated good efficacy in preventing and treating bleeds without inhibitor development in previously treated patients.
To view the Multimedia News Release, go to: http://www.multivu.com/mnr/71400529-novoeight-reduction-of-bleeding-haemophilia-a
At the heart of Ketel One Vodka lies one family’s unwavering passion for crafting the world’s finest spirits. Inspired by over 325 years of distilling expertise, the Nolet family brings old-world pot still craft and modern distilling techniques together in one flawless process. From Joannes to Jacobus to Carolus Sr., creator of Ketel One Vodka, to Carolus Jr. and Bob Nolet today, each of the 11 generations of Nolet family distillers is tasked with upholding a legacy of distilling excellence. Some may consider the Nolets a little obsessive, but those individuals just don’t understand. Everything must be done with meticulous attention to detail, because the family name is riding on every bottle of Ketel One Vodka.
“We take our work very seriously, not ourselves,” said Carl Nolet Jr., 11th Generation Nolet Family Distillery. “The stories we tell are all true and based on family events, beliefs and the pressure of upholding 11 generations of legacy for generations to come.”
To view the multimedia release go to:
http://www.multivu.com/players/English/7975151-ketel-one-vodka
InSightec Ltd, the leader in magnetic resonance imaging (MRI)-guided Focused Ultrasound therapy, announced that the U.S. Food and Drug Administration (FDA) has approved ExAblate® MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. This is the second FDA approval for ExAblate, which has been used widely since it was approved in 2004 as a non-invasive, outpatient, therapy for uterine fibroids.
To view Multimedia News Release, go to http://www.multivu.com/mnr/56632-insightec-fda-approves-exablate
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/
Dune Medical Devices, Inc., announced today that its breakthrough intra-operative tissue assessment tool for early-stage breast cancer surgery, the MarginProbe System, has received Premarket Approval (PMA) by the United States Food and Drug Administration. The technology significantly improves surgeons’ ability to intra-operatively identify
