At the start of its 'European Month of the Brain' initiative, the European Commission has earmarked some €150 million of funding for 20 new international brain research projects. It will bring the total EU investment in brain research since 2007 to over €1.9 billion. The 'European Month of the Brain' (#brainmonth) will highlight European research and innovation in the area of neuroscience, cognition and related areas through over 50 events across Europe this May. The initiative aims to showcase the latest achievements in the field, but also to urge a more decisive effort to combat brain diseases. It also aims at highlighting how studying the brain can revolutionise computing. The initiative comes as the profile of brain research has been raised recently with ambitious new projects in the EU (FET Flagship Human Brain Project – IP/13/54 and MEMO/13/36) and the US (BRAIN project).European Research, Innovation and Science Commissioner Máire Geoghegan-Quinn said: "Many Europeans are likely to be affected by brain-related disease or illness during their lifetime. Treating those affected is already costing us €1.5 million every minute and this burden on our healthcare systems is likely to rise as our population ages. Brain research could help alleviate the suffering of millions of patients and those that care for them. Unlocking the secrets of how the brain works could also open up a whole new universe of services and products for our economies."Some 165 million Europeans are likely to experience some form of brain related diseases during their life. As the population ages, with more people affected by Alzheimer's and other neurodegenerative or age-related mental disorders, treatment costs are likely to go up sharply. Finding better ways of preventing and treating brain diseases is therefore becoming urgent. Understanding how the brain works is also important to keep our economies at the forefront of new information technologies and services.The 'European Month of the Brain' will underline the crucial importance of brain research and healthcare for our societies and economies; showcase EU achievements in these fields; debate the future direction of research and policy; discuss how to improve the allocation of resources within and between individual countries; and lift taboos around mental health. See also MEMO/13/390.BackgroundThe 20 projects which are shortlisted for EU funding are expected to deliver new insights and innovations in key areas such as traumatic brain injury, mental disorders, pain, epilepsy and paediatric conduct disorders. While the projects cannot be named before the grant agreements are finally concluded, all are expected to start from this summer. Industry and small business partners will have a particularly strong involvement in three of the areas - mental disorders, epilepsy and paediatric conduct disorders – to fuel innovation and real-life solutions.The EU budget has provided more than €1.9 billion for brain research since the start of the current EU framework programme for research, FP7 (2007-2013). This has funded 1,268 projects with 1,515 participants from the EU and beyond. There will still be opportunities for brain research under all three pillars – 'excellent science', 'industrial leadership' and 'societal challenges' of Horizon 2020, the next EU research and innovation programme. The 'Health, demographic change and well-being' challenge, which will aim to improve the diagnosis, understanding and treatment of diseases, will be particularly relevant.More than 50 events on the human brain are on the 'European Month of the Brain' programme, from conferences, workshops and meetings to summer schools and teaching courses. Six of these events are being organised by the Irish EU Presidency. The European Commission will organise two major conferences, on 14 May in Brussels and – together with the Irish EU Presidency - on 27/28 May in Dublin.For more information, please visit: http://ec.europa.eu/research/conferences/2013/brain-month/index_en.cfm

Delivering on its commitment to advance and optimize clinical diagnostic laboratories, Beckman Coulter has launched a new benchtop hematology analyser for mid- to high-volume laboratories. Building on the company’s proven cellular analysis technology, Beckman Coulter’s new UniCel DxH 600 Coulter cellular analysis system — complete with recently U.S. Food and Drug Administration (FDA) cleared advanced software — provides laboratories with exceptional quality results, improved first-pass accuracy and automatic rerun and reflex testing, thereby reducing overall manual review rates and processes. The hematology laboratory’s single most important step, and most time consuming, is the manual review. By reducing manual differential rates, the new analyser frees mid- to high-volume labs to focus time on quickly and accurately reporting patient results, improving patient health and reducing the overall cost of care.
"This new hematology analyser has the ability to transform the hematology lab with unparalleled efficiency, revolutionary scalability and quality of results,” said John Blackwood, senior vice president, Product Management at Beckman Coulter Diagnostics. “The UniCel DxH 600 advances the technology that made Coulter systems the worldwide market leader in hematology and will change how labs manage their cellular analysis process.”
The UniCel DxH 600 is equipped with robust software that provides new features, enhancements and research-use parameters to improve laboratory efficiency, reliability and quality. The software saves time by allowing labs to partially release patient results manually or automatically via decision rules and offers users the ability to create and edit decision rules during instrument operation and offers pre-defined decision rules using Cell Population Data.Additional features of the software include the ability to track workload by the day, hour and test, as well as providing automatic notification of STAT samples that have not been processed or released within an expected time frame, helping users to report STAT results in a timely and efficient manner.With the same technology, user interface and consumables as the UniCel DxH 800 Coulter cellular analysis system, the UniCel DxH 600 brings true standardization of results and process to the hematology laboratory, reducing laboratory personnel training and simplifying laboratory consumable inventory management. To further enhance standardization, all new DxH 800 analysers will be installed with the advanced software; and current DxH 800 customers will be upgraded.For more information, please visit: Beckman Coulter

A recently published study funded by the Canadian Institutes of Health Research looks at the appropriateness of spinal imaging in Canada, against a background of increasing costs of diagnostic imaging, and the need to find efficiencies. An estimated 50–80 percent of the adult population will experience spine related complaints such as low back pain intheir lifetime, and imaging of the lumbar spine accounts for approximately one-third of all MRI procedures in some Canadian provinces. This study included a review of the literature, survey of Canadian spine surgeons and provincial utilisation data. In the 22 studies identified on the appropriateness of spine imaging there was little consensus on what defined appropriateness and little consideration of outcomes important to patients. All studies found some inappropriate use.The survey of Canadian spine surgeons found that the vast majority (74 percent) require imaging studies for all spine-related referrals. MRI is the most common imaging required. Even when an imaging study is performed, 53 percent of surgeons refused more than 20 percent of all referrals without a consultation, and less than 20 percent of patients who are assessed are candidates for surgery. The study's authors suggest that the current system of referring patients with spine-related complaints for surgical assessment in Canada appears to lead to much unnecessary imagingProvincial utilisation data showed an increase in MRI imaging for the spine between 2001-2011, but no decrease in x-ray of CT, with x-rays accounting for 40 percent of all spine imaging costs. The authors suggest that improved health system coordination for patients with spinal complaints may help to improve efficiencey of spine imaging use (e.g. diagnostic imaging pathways to reduce the need for 'lead-up' testing with x-ray or CT spine before MRI. Standardised assessment of patients with low back pain could streamline referral of appropriate patients for advanced spine imaging and surgical consultation.Reference: Busse J et al. Appropriateness of spinal imaging use in Canada. (2013) Ottawa: Canadian institutes of Health Research. Available at: http://nationalpaincentre.mcmaster.ca/documents/AppropriatenessofSpinalImagingFinalReportApril252013.pdf 

Hologic  has announced its results for the second fiscal quarter ended March 30, 2013.Highlights Include:Financial:Revenues of $612.7 million, net of a $(6.4) million adjustment related to contingent revenue earned and received under Gen‐Probe Incorporated's (Gen‐Probe) collaboration agreement with Novartis.Non‐GAAP adjusted revenues of $619.1 million, including the aforementioned $6.4 million adjustment.Net loss of $51.1 million, or $0.19 per diluted share, calculated in accordance with U.S. generally accepted accounting principles (GAAP).Non‐GAAP adjusted net income of $93.8 million, or $0.35 per diluted share, and adjusted EBITDA (non‐GAAP adjusted earnings before interest, taxes, depreciation and amortization) of $211.8 million.Completed sale of the Company's LIFECODES business to Immucor, Inc. on March 22, 2013, for approximately $85 million in cash (adjusted for working capital items) and a potential contingent payment of $10 million.Improved financing flexibility and terms on existing debt with:the February 14, 2013 exchange of $370 million of outstanding 2.00% Convertible Senior Notes due 2037 for $370 million, 2.00% Convertible Senior Notes due 2043, which, among other things, extended the first put date by four years to December 2017; and the March 20, 2013 Credit Agreement amendment, which reduced interest rates on each of the Company's Term Loan A facility and senior secured revolving credit facility by 100 basis points.Product Approvals:U.S. Food and Drug Administration (FDA) clearance of the Company's breast tomosynthesis (2D + 3D mammography) Affirm breast biopsy guidance system received on January 11, 2013.FDA clearance of the Company's APTIMA Trichomonas vaginalis Assay for use on its fully‐automated PANTHER System received on January 9, 2013.FDA clearance of the Company's contrast‐enhanced digital mammography for improved visualization of breast tissue received on January 29, 2013.Honours and Publications:The Company's tomosynthesis technology reported to be the "new standard of care" in an independent survey by healthcare research firm KLAS Research in March 2013.Highlights Subsequent to the Quarter Include:Oslo study published in the print edition of Radiology on April 4, 2013 (previously published electronically on January 7, 2013), reporting the addition of the Company's tomosynthesis screening technology significantly increased cancer detection while reducing the number of false positives.A new study published online in April 2013 by European Radiology supporting the use of the Company's tomosynthesis screening technology in breast cancer screening programs using independent double reading with arbitration.A new study published online in April 2013 by The Lancet Oncology reporting the results of the Italian study, "A prospective comparative evaluation of the integration of 3D digital mammography with tomosynthesis in population breast screening – the STORM trial," which reports tomosynthesis improves breast cancer detection and has the potential to reduce false positives. Acceptance in the American Journal of Roentgenology of a paper reporting the results of a U.S. study, presented at the 2012 Radiological Society of North America (RSNA), which computes and compares results from six radiologists who interpreted screening mammography studies with and without the use of Hologic's tomosynthesis technology. Acceptance in Radiology of a paper by Yale University School of Medicine researchers, presented at RSNA in 2012, reporting the results of a study evaluating the benefits of tomosynthesis in patients of different ages and breast density types.

Global warming trends have a significant influence on the spread of West Nile Virus to new regions in Europe and neighboring countries, where the disease wasn’t present before, according to a new study by the University of Haifa. The study was commissioned by the European Centre for Disease Prevention and Control (ECDC) in Stockholm, which belongs to the European Union. The study found that rising temperatures have a more considerable contribution than humidity, to the spread of the disease, while the effect of rain was inconclusive.“These results are an additional testament that global warming contributes to the outbreak of mosquito-borne and other temperature-sensitive vector-borne diseases. The indications to this are piling up in different parts around the globe”, says Dr. Shlomit Paz, who led this research. These findings were recently published in the online scientific journal, “Plos One”.West Nile Virus is spread by mosquitoes that repeatedly bite infected birds. The potential threat the infection poses to man is the possibility of causing irreversible brain damage or even death through encephalitis or meningitis. The elderly and people with weak immune systems are most susceptible.The research, conducted by a team from the University of Haifa led by Dr. Shlomit Paz, also included Dr. Dan Malkinson and Gil Tzioni from the Department of Geography and Environmental Studies, along with Prof. Manfred Green, the head of the School of Public Health, and in collaboration with Prof. Jan Semenza from the ECDC. The Israeli research team was chosen by the EU’s ECDC, after winning an international tender.The current study examined the link between daily temperature, humidity and precipitation data and West Nile incidence in Europe and neighboring countries. “We used statistical tools and found that as a result of heat waves, a dramatic increase in the number of cases resulted from increased activity of the virus and a growth of the mosquito population”, claims Paz. According to her, these results were seen in various countries.Paz says these results have a significant importance considering the rising temperatures seen in Europe in recent years. She is now conducting a continuing study on the subject for the ECDC and the French research center, CIRAD. “In our new research our aim is to look for additional potential influences on the spread of the disease, such as the location of mosquito populations or various human aspects”, she says. Paz hopes their findings will make it possible to develop a model for better predicting the future spread of the virus in Europe, “Such a model will allow the ECDC to guide the different European countries on how to better prepare in advance for West Nile outbreaks and perhaps will even allow restraint of such outbreaks in the future”.Source: Newswise

CARMAT, the designer and developer of the world’s most advanced project of total artificial heart, announced that it obtained the approval of four renowned international cardiac surgery centers in Belgium, Poland, Saudi Arabia and Slovenia to proceed with the first clinical implantations of its bioprosthetic total artificial heart.These institutions are the St Pierre University Hospital (Brussels, Belgium), the Silesian Center for Heart Disease (Zabrze, Poland), the Prince Sultan Cardiac Center (Riyadh, Saudi Arabia), and the University Medical Centre Ljubljana (Ljubljana, Slovenia).All these institutions share excellence in surgical results and heart patient care, depth of patient recruitment and experience in innovative medical devices pre-market clinical trials.In a common statement, Prof. Didier de Cannière, Chief of the Department of Cardiac Surgery at St Pierre University Hospital in Brussels, Belgium, Prof. Marian Zembala, Chairman, Department of Cardiac Surgery and Transplantation and Director of the Silesian Center for Heart Diseases in Zabrze, Poland, Prof. Borut Geršak, Head of the Department of Cardiovascular Surgery at the Ljubljana University Medical Centre, in Ljubljana, Slovenia, and Prof. Antonio Calafiore, Head of the Department of Adult Cardiac Surgery at Prince Sultan Cardiac Center in Riyadh, Saudi Arabia, declared: “We are very glad to share our experience and knowledge and thus contribute to this extraordinary project, as end-stage heart failure is indeed an international health issue. CARMAT’s bioprosthetic artificial heart could bring true innovation to the heart failure surgical community and we are looking forward to starting its implantation and to exploring its potential benefits for our patients.”Prof. Alain Carpentier, co-founder and Scientific Director at CARMAT, comments: "I have been very pleased to learn that the leaders of these prestigious departments are willing to join us in the evaluation of the Carmat bioprosthesis. As recognized experts in the field, they will be able to appreciate first-hand the unique features and remarkable performances of this prosthesis."Marcello Conviti, CEO of CARMAT, concludes: “The patient selection process and the training of the clinical teams are ongoing in these four countries, supported by our French proctors, Prof. Christian Latrémouille, Cardiac Surgeon at the Georges Pompidou European Hospital in Paris and Prof. Daniel Duveau, Medical Director of the Thorax Institute and of the Department of Thoracic and Vascular surgery at University Hospital in Nantes. Implantations could start shortly following the completion of the training. Carmat expects to receive additional approvals in a near future, potentially in France (ANSM approval) and in other countries.”Source: CARMAT

Both healthcare and technology professionals are invited to join the Health Hack Dublin competition (11th and 12th May) on the eve of international eHealth Week 2013. Together they will be producing high quality software that has the potential to transform healthcare.Leading in to eHealth Week, Health Hack Dublin will shine a spotlight on the theme of “Innovative Healthcare and Wellbeing” and the use of technology to enhance service delivery and to improve patient outcomes.Healthcare professionals (consultants, GPs, nursing staff and health managers) are invited to collaborate with developers on ideas and challenges that can benefit from the creative application of technology. Teams will look at devising apps and will explore the use of technology to improve access and quality of care in the community. One of the key tasks will involve a “marathon” of software coding.Health Hack Dublin is organised by the Irish Computer Society with support from Kainos, Northern Ireland Connected Health Innovation Centre (CHIC) and EMC and follows on from a successful “Health Hack Northern Ireland” event, which took place in Belfast last year. Speaking about hosting the event, ICS CEO Jim Friars said “We are delighted to facilitate this very unique opportunity. Our goal is to inform healthcare professionals about the potential of technology, and to empower technology innovators with a platform and network for improving healthcare.”Chief Technology Officer of Kainos, Tom Gray is the brains behind the operation. “We know there is great interest out there and that there is a real need for more collaboration in the area of Connected Health. The result should be a technology prototype, that may form the basis of later development. Health Hack Dublin will be richly rewarding for everyone involved.”As part of Ireland’s Presidency of the EU, the Department of Host will host a High Level eHealth Conference as part of eHealth Week. Irish Minister for Health Dr James Reilly said “collobarative eHealth solutions are critical in the delivery of a world class health system and offer significant opportunities for improved patient care and stimulating economic growth. I’m delighted to see such enthusiasm at ground level for finding solutions to real problems and look forward to seeing the results of Health Hack Dublin.”Health Hack Dublin is open to all healthcare and technology professionals and will take place in ICS, Ballsbridge, Dublin 4.To register for the event and for further information on Health Hack Dublin, go to www.healthhack.eu.

Quicksilva, an independent supplier of healthcare IT systems is providing real-time access to the NHS Personal Demographic Service (PDS) for the North East Ambulance Service Foundation Trust (NEAS). NEAS’s 111 Service evaluation project has been able provide the entire North East region with access to patient records in real-time to allow instant verification of NHS numbers whilst the caller is still on the line, helping staff to provide a quicker, more efficient service.NHS 111 replaces the current 0845 service and it is expected that as a result ambulances will only be sent to those in need of emergency care as a priority, and that those with non-critical illnesses will be advised on the best care for the patient.There are 11 pilot schemes in the UK, but only two are currently operating with real-time PDS look-up. Other pilots are still using old batch-tracing methods, which are more time-consuming and often mean patients need to be called back. Quicksilva’s orQestra® will provide back-end connectivity to ensure that call handlers can identify patients within minutes of the call being taken.Steven Pratt, IT Systems Manager at NEAS said: “orQestra has been purchased to provide the immediate requirement to enable the new NEAS NHS 111 offering to be able to assess the NHS Spine for PDS to enable the ability to improve patient data quality to produce verified NHS numbers. This North East contract was successfully won in 2012. As such, NEAS have continued to lead the way on how they deal with assessing patients’ needs through the continued use of NHS Pathways and the enhancement of their directory of services which they expect to prove invaluable in sourcing the most appropriate care for their patients.”orQestra® is the only end-to-end service to be accredited under NHS Connecting for Health’s Interoperability ToolKit (ITK) Accreditation Configuration, ‘ITK Spine Mini Service’ deployed throughout the NHS to connect Trusts and healthcare providers to ensure patient data is available via the Personal Demographics Service (PDS). Its selection in support of the new 111 non-emergency number is a further application of orQestra® which could in future be rolled out to other blue light services such as the Police and Fire Service.Gayna Hart, Managing Director of Quicksilva said: “It is vital that call handlers have access to the right data when managing 111 calls. They need to make split second decisions and having access to the Spine PDS in real-time is vital if that’s to happen. We’re seeing great results from the use of orQestra® with one hospital service running around 3500 queries in less than an hour – and with a 99.6% validation rate it’s no wonder they are reporting very early payback periods. We have had days when they have validated around 7000 patients. The benefits of the solution in healthcare scenarios are significant, and we believe there’s potential for this solution to be used across other emergency services, NHS and social care as well.”

Albertans living with heart failure will have their conditions monitore from home as part of a new home health care pilot project in Alberta, Canada,  a collaboration between the Government of Alberta, Alberta Health Services, GE Healthcare and GE Canada.Canadian provinces are exploring new models of care to address issues around capacity for aging patients, coordination of care and support for families, as well as overall management of data and resources to inform better system planning.The province of Alberta has been at the forefront in looking for differentiated solutions to address these challenges and this innovative home health care pilot project, called MyHome Health will aim to redefine the way future primary care is delivered by integrating Intel-GE Care Innovations™ technology with GE Healthcare’s IT capabilities that will be enabled by our process improvements portfolio to offer a new, end to end solution that addresses Alberta’s ageing population and rise of chronic illness management.The pilot project will target patients living in Edmonton, AB, Canada, who have been diagnosed with heart failure, are over the age of 50, and currently living at home. Patients will use the Intel-GE Care Innovations™ Guide – a clinically-driven remote care platform with in-home touch-screen device for patient use to monitor their condition and connect with their healthcare team from home, while learning how to independently manage their health condition.The Primary Care Network will initially recruit eligible patients, with the potential to expand to other primary care networks. Up to 250 patients will be enrolled in the pilot, which is expected to last 12 to 18 months and begin late May 2013. To ensure a relevant and unbiased assessment of the MyHome Health program, the study will be validated by independent research organisations.The pilot project is expected to demonstrate measurable clinical and economic value by enabling eligible patients to remain independent longer and identifying cost savings and resource efficiencies for Alberta’s healthcare system.“GE Healthcare strives to be at the forefront of the patient experience. Home health technology paired with our leading IT and consulting solutions will provide a unique one GE Healthcare solution to help address cost, quality and access, which are some of Alberta’s toughest healthcare challenges,” said GE Healthcare Canada Vice-President and General Manager Peter Robertson.Image credit: GE HealthcareCaption:Premier of Alberta, Canada Alison Redford and Christine Schelstraete, Virtual Care Nurse, MyHome Health Program in a demonstration of the GE in-home technology that will be used to support heart patients.  

The AMPLATZERTM Cardiac Plug (Image Credit: St. Jude Medical, Inc.)St. Jude Medical, Inc., a global medical device company, today announced the first patient implant in a new pivotal trial evaluating the company’s AMPLATZER™ Cardiac Plug (ACP) for the prevention of stroke. The AMPLATZER™ Cardiac Plug Clinical Trial (ACP Trial) is designed to determine if the ACP device is safe and effective in preventing thrombus (blood clots) from migrating out of the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AF) who have a high risk for stroke.The ACP Trial is a prospective, randomized, multi-center clinical study with an adaptive trial design that will enroll no fewer than 400 and no more than 3,000 patients at up to 90 sites in the U.S. and Canada. The trial compares the safety and efficacy of the ACP device to traditional medical treatment using long-term, blood-thinning medication.Dr. Christian Machado, director of electrophysiology at the Providence Hospital Heart Institute, Southfield, Mich., and investigator in the study, performed the first AMPLATZER Cardiac Plug implant in the pivotal phase of the trial. The procedure was assisted by Dr. Thomas Forbes, a pediatric interventional cardiologist who is also an investigator in the study.“Patients with untreated atrial fibrillation are four to five times more likely to have a stroke, which greatly increases their risk of disability or death. Dr. Forbes and I consider the ACP Trial an important study as we look for ways to reduce this risk,” said Dr. Machado. “We are excited to contribute research that may help expand treatment options for patients.”The AMPLATZER™ device has been the market leader for LAA occlusion since its introduction in 2008. A self-expanding occlusion device constructed from nitinol mesh, and delivered via catheter, the ACP device is designed to completely seal the LAA (a tubular-shaped, muscular appendage connected to the left atrium of the heart) at its opening, and minimize blood clots from forming in the LAA and migrating into the bloodstream.According to the American Heart Association, an estimated 2.7 million Americans have AF and the likelihood of developing it increases with age. Defined as a quivering or irregular heartbeat (arrhythmia), AF can lead to blood clots, stroke, heart failure and other heart-related complications. AF is the most common heart rhythm abnormality in people over the age of 65.During episodes of AF, the heart contracts at rapid and irregular intervals, which can increase the likelihood of clot formation in the LAA. If a clot is released from the LAA, it can enter the blood stream and potentially travel to the brain, resulting in a stroke.Each ACP Trial study site will have physicians who specialize in electrophysiology (doctors trained to diagnose and treat abnormal heart rhythms) and interventional cardiology (doctors who perform minimally invasive, catheter-based procedures for the heart) forming a collaboration between the two specialties.“The current standard of care for the prevention of stroke is warfarin or other oral blood-thinning medications that can be difficult for some people to tolerate, and may carry a risk of serious complications, such as bleeding,” said Dr. James Hermiller, an interventional cardiologist from St. Vincent Hospital in Indianapolis and ACP Trial investigator. “As physicians, we are always looking for new ways to best treat our patients. We hope the ACP Trial will prove that we can reduce the risk of stroke in patients with atrial fibrillation through this minimally-invasive procedure.”According to the World Health Organization (WHO), an estimated 15 million strokes occur worldwide each year. In 2010, stroke cost the U.S. an estimated $53.9 billion in health care services, medications and missed days of work. Approximately 87 percent of all strokes are ischemic, which occur when blood clots block the blood vessels to the brain. AF is responsible for approximately 20 percent of ischemic strokes, and about one-third of AF patients will have a stroke in their lifetime if not treated appropriately.“The AMPLATZER Cardiac Plug has shown great promise in international markets and we look forward to establishing the evidence required to make it available in the U.S.,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “The ACP Trial is another example of significant investment by St. Jude Medical to develop landmark clinical evidence. This trial will help us understand the long-term benefits of LAA occlusion therapy for lowering the risk of stroke in atrial fibrillation patients and potentially improve their quality of life.”Earlier this year, St. Jude Medical received CE Mark approval and launched the AMPLATZER™ Amulet™ Left Atrial Appendage Occluder. Considered a next-generation occlusion device, the AMPLATZER Amulet design was driven by feedback from physicians who have been implanting the AMPLATZER Cardiac Plug in Europe since 2008. The Amulet occluder is built with a longer lobe and waist than previous versions to allow for easier placement. The end screw is flush with the disc to create a smooth surface within the left atrium, and the larger disc diameter offers increased orifice coverage. The AMPLATZER Amulet device is offered in eight sizes to accommodate varying anatomies. Additionally, the device is pre-loaded into the delivery catheter, which simplifies device preparation and ultimately streamlines the entire procedure for the physician.The AMPLATZER Cardiac Plug device is currently not approved for use in the U.S. The ACP Trial is conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). Source: St. Jude Medical