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VACC exam Dumps Source : VACC Vascular Access

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Test appellation : VACC Vascular Access
Vendor appellation : Medical
: 80 actual Questions

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Medical VACC Vascular Access

FDA permits marketing of first catheter-primarily based programs used to create vascular entry for hemodialysis patients | killexams.com actual Questions and Pass4sure dumps

SILVER SPRING, Md., June 22, 2018 /PRNewswire-USNewswire/ -- these days, the U.S. meals and Drug Administration authorised advertising of two catheter-primarily based gadgets designed to create a connection to veins and arteries in patients with persistent kidney disorder who want hemodialysis. 

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

above all, the FDA granted advertising and marketing authorization for using the Ellipsys Vascular entry paraphernalia and the everlinQ endoAVF gadget to gain what's called an arteriovenous (AV) fistula for sufferers who want hemodialysis entry.

"Dialysis is a indispensable and life-saving technique for heaps of people. With concomitant action, there should live extra, less-invasive vascular entry alternatives for sufferers who will require hemodialysis," eminent Bram Zuckerman, M.D., director of the Division of Cardiovascular contraptions in the FDA's middle for contraptions and Radiological fitness.

according to the countrywide Institutes of health, more than 661,000 americans hold kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis makes disburse of a dialyzer, or synthetic kidney, to filter a patient's blood outside of their body. before sufferers can birth dialysis, youngsters, they necessity to hold an AV fistula created. An AV fistula is traditionally made by using surgically becoming a member of an artery and a vein below the epidermis within the arm. After a while, the age vein can then obtain the two needles used for each and every hemodialysis session. Surgically created AV fistulas typically rob a number of months to heal and for the vein to age before being usable for hemodialysis.

The devices granted advertising and marketing authorization nowadays are designed to create AV fistulas percutaneously (in the course of the epidermis). A catheter is inserted into a blood vessel in the arm and is guided to the website of the planned AV fistula. The devices then deliver power to shape a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular access paraphernalia makes disburse of one catheter, the everlinQ endoAVF system makes disburse of two.

For the Ellipsys Vascular access equipment, the FDA reviewed facts from a non-randomized, multi-middle examine of 103 sufferers. The Ellipsys Vascular entry paraphernalia become utilized in a process to create an AV fistula in these sufferers, of which 92 patients (89.three percent) met the standards for a usable AV fistula within three months after the process.  just about extreme patients (96.1 p.c) required an further procedure (akin to balloon angioplasty) in the first one year to preserve the fistula.

For the everlinQ endoAVF equipment, the FDA reviewed facts from a non-randomized, multi-core analyze of 60 patients, apart from helping records from three other studies and medical disburse of the gadget backyard the U.S. The everlinQ endoAVF system become used in a procedure to create an AV fistula in these sufferers. on the total sight at, fifty two sufferers (86.7 percent) met the criteria for a usable AV fistula within three months after the technique.  just about extreme patients (96.7 %) required an additional process on the time the fistula turned into created, while 28.3 p.c of sufferers required an extra manner (corresponding to balloon angioplasty) within the first 365 days to retain the fistula.

each gadgets are contraindicated, or should not live used, for introduction of anastomoses (connections) in vessels that are less than two millimeters in diameter or too far aside (as an example, in the wrist or within the hand). For both gadgets, issues consist of blocking (occlusion) or cave in (stenosis) of the fistula, bruising and want for additional tactics.

The Ellipsys Vascular access system and everlinQ endoAVF gadget were reviewed throughout the De Novo premarket assessment pathway, a regulatory pathway for some low to mediocre possibility gadgets of a brand novel classification. This motion besides creates a brand novel regulatory classification, which means that subsequent gadgets with the very supposititious disburse might besides evanesce throughout the FDA's 510(okay) system, whereby contraptions can obtain marketing authorization with the aid of demonstrating immense equivalence to a predicate gadget.

The FDA granted marketing authorization of the Ellipsys Vascular entry gadget to Avenu clinical.

The FDA granted advertising and marketing authorization of the everlinQ endoAVF paraphernalia to TVA scientific, Inc.

more assistance:FDA: lately authorized DevicesFDA: De novo pathwayNIH: Hemodialysis

The FDA, an company inside the U.S. department of health and Human capabilities, protects the public health with the aid of assuring the defense, effectiveness, and safety of human and veterinary medicine, vaccines and different biological items for human use, and scientific contraptions. The company is besides chargeable for the defense and protection of their nation's food give, cosmetics, dietary dietary supplements, items that provide off digital radiation, and for regulating tobacco items.

Media Inquiries: Stephanie Caccomo, 301-348-1956, stephanie.caccomo@fda.hhs.gov  client Inquiries: 888-data-FDA

Cision View fashioned content with multimedia:https://www.prnewswire.com/news-releases/fda-enables-advertising-of-first-catheter-primarily based-methods-used-to-create-vascular-entry-for-hemodialysis-sufferers-300670882.html

supply U.S. meals and Drug Administration


10 information About Rosacea | killexams.com actual Questions and Pass4sure dumps

The measles was once one of the world’s most typical childhood illnesses. since the introduction of the measles vaccine, besides the fact that children, the disease is infrequently considered in the U.S. but people noiseless hold cause of vicissitude about indicators enjoy the telltale measles rash: In 2018, there hold been 349 pronounced circumstances of the measles across 26 states and Washington, D.C. The 12 months earlier than, 120 people shrunk the disorder. listed below are seven things to learn about measles indicators and treatments.

1. each person used to regain the measles.

There changed into a time no longer so lengthy ago when exhibiting measles symptoms was a close-ubiquitous portion of childhood. in the 4th century CE, chinese language alchemist Ko Hung wrote of the modifications between smallpox and measles, and the disease was described within the ninth century by using the notorious Persian doctor Rhazes. there hold been famous epidemics of the ailment in the eleventh and 12th centuries [PDF].

within the years earlier than the primary licensed measles vaccine looked within the U.S. in 1963, an estimated ninety percent of toddlers caught the measles before they had been 15. The disease changed into a leading explanation for death for infants—and in some places devoid of entry to vaccinations and clinical care, it nevertheless is. these days, up to 5 percent of babies in areas devoid of entry to first rate scientific care die of the measles yearly.

The CDC estimates that earlier than the existence of the measles vaccine, there hold been between 3 and four million measles circumstances in the U.S. per yr, approximately 400 to 500 of them fatal—however vaccinations hold decreased the incidence of the disease by using ninety nine percent. In some years, fewer than a hundred people constrict the disorder in the U.S.

2. The measles virus is totally contagious.

The measles virus is regarded one of the crucial contagious viruses around: with out vaccination, round 90 p.c of americans who're exposed to the virus will circle into infected.

The sickness is led to with the aid of the unfold of a sort of virus called morbillivirus, which will besides live transmitted through the air via breathing, coughing, or sneezing. The virus can reside within the air for up to two hours after an contaminated person coughed—that means that you simply don’t necessarily should live standing subsequent to someone with the measles to regain it from them.

3. It may cause greater than only a measles rash.

a person uncovered to measles will start to array signs seven to 14 days after publicity. common measles indicators consist of coughing, congestion, fever, and most famously, a full-body dermis rash. however a third of measles circumstances contain problems ranging from diarrhea to pneumonia, brain swelling, and coma. Pneumonia motives around 60 % of fatalities when it comes to measles complications.

toddlers under 5 are specially liable to getting issues and death from the ailment. One in 10 will constrict an ear an infection, perhaps resulting in permanent listening to harm, and one in 20 will regain pneumonia. One or two out of every 1000 youngsters who constrict the measles will die, according to the CDC, many from pneumonia.

four. The measles vaccine is terribly valuable.

The measles is combined with vaccines in opposition t two other illnesses—mumps and rubella—and when administered as designed, it live tremendously valuable. experts suggest that infants regain their first dose of the MMR vaccine on their first birthday (however not before). Then, they should noiseless regain the 2d dose before they enter kindergarten. If a toddler doesn’t regain vaccinated before they’re 12, they may noiseless nevertheless regain the vaccine: two doses a month aside. In most cases, these two doses of the vaccine may noiseless live adequate to present you immunity for life (youngsters some experts are now cautioning booster shots may live a splendid idea for some adults).

if you’re exposed to the virus and haven’t been vaccinated, an instantaneous dose of the vaccine can provide some coverage from the disease, so long as you regain it within 72 hours of publicity.

5. Measles is considered eradicated within the U.S. ...

due to helpful vaccinations, as of 2000, measles is not any longer a threat within the U.S., in line with the CDC’s standards. The disorder is regarded eliminated, which potential that it hasn’t been constantly transmitted in a particular geographical location for at least a yr. So notwithstanding there’s the occasional outbreak of instances, it’s regarded eradicated since it’s no longer a constant possibility anymore. In 2016, the realm health corporation declared the sickness to live eradicated throughout the total thing of North and South the usa.

6. ... but you'll want to nonetheless regain vaccinated.

Measles isn’t approved within the U.S., however that doesn’t signify you could bypass your vaccinations: although domestic-grown measles has been eradicated, americans within the U.S. noiseless Come down with it. That’s because measles is noiseless a mammoth vicissitude elsewhere on the planet, and tourists can convey it home with them, spreading it to unvaccinated populations within the U.S.

That comprises infants. infants below 5 are one of the crucial susceptible populations when it comes to measles infections, however toddlers aren’t frequently vaccinated unless they’re 12 months ancient (the CDC recommends that before overseas evanesce back and forth, “infants 6 months through eleven months of age should noiseless receive one dose of MMR vaccine” after which regain a shot once again once they’re a slight older). That makes it tremendously crucial for everybody round them to live vaccinated, so that the disease can’t spread.

in addition to inoculating individuals towards diseases, the measles vaccine operates on the precept of herd immunity. When basically a complete population is vaccinated, it’s very challenging for the sickness to unfold. That protects individuals who aren’t inoculated, enjoy babies, or individuals whose bodies didn’t reply to the vaccine for anything rationale.

7. individuals noiseless regain measles in the united states.

in view that measles turned into declared eliminated in 2000, there had been notably few circumstances suggested here, but a significant variety of americans hold caught the sickness during the past few years. In 2004, there hold been just 37 cases of measles said in the U.S. Ten years later, in 2014, there hold been 667—most of whom were people who weren’t vaccinated. (That number become surprisingly excessive, and went perquisite down to 188 situations the subsequent year.)

The CDC blames concomitant measles outbreaks on low quotes of vaccination. One 2016 evaluation of measles experiences create that out of 970 measles instances, nearly forty two p.c of patients had opted out of getting the vaccine for non-clinical motives.

Europe has besides considered a surge in measles circumstances within the remaining few years. Between 2016 and 2017, measles situations in Europe quadrupled, from 5273 instances to more than 21,000, in keeping with the realm fitness company. Thirty-five of these 21,000 individuals died from the ailment. here is perilous information for americans, too, on account that most U.S. measles instances may besides live linked returned to travelers coming into the U.S. from places enjoy Europe. So regain your vaccinations!


The Anti-Vaccination circulation: Spreading Misconceptions,Fueling Epidemics,Circulating Misinformation | killexams.com actual Questions and Pass4sure dumps

“old-fashioned” illnesses, akin to measles, hold affected over 900 americans during the past three years in the u.s.. “informed” celebrities, similar to Dr. Oz, hold spread misconceptions about autism relating to vaccination. One factor’s for definite: “bad,” “unchecked,” and “useless” vaccinations are the factors for the cease of polio, measles, smallpox, and pertussis epidemics. on the immediate of the 18th century, Edward Jenner invented the first vaccine by artery of injecting cowpox-infected corporeal fluid perquisite into a boy that became contaminated with the sickness. Ever when you deem that then, deadly illnesses had preventions as quickly as ethical, perfect, and protected vaccines hit the market. For a long time and even centuries, people felt privileged to hold access to this medical innovation that saved thousands and thousands of lives internationally. currently, youngsters, preventable diseases unparalleled in a long time hold resurfaced as a result of the anti-vaccination circulate. This circulation resulted from residents of first world international locations taking this privilege for granted by artery of believing that diseases such as measles hold been fully eradicated. Misconceptions about inoculation blew fully out of percentage, starting from unscientific hyperlinks with autism to fraudulent anecdotes and studies. due to this fact, medical doctors equivalent to Paul Offit hold dedicated their lives to putting off the negative stigma that frequently surrounds immunization. The anti-vaccination circulate, fueling misconceptions and catastrophically harming babies, threatens the well-being of society. Vaccinations must live reinstated as one of the most helpful and vital modern-day tendencies of mankind to evade further denouncement and devaluation incited by means of skeptics.

On February 28, 1998, an article was published in the Lancet titled, “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental sickness in babies”Wakefield). The doctor in the back of the article, Andrew Wakefield, became absolutely the man that sparked the autistic aspect of the anti-vaccine flow. Wakefield changed into the primary to ever submit a analyze that confirmed a correlation between autism and vaccination. This test become absolutely disproved and even retracted through the Lancet, however its hold an impact on when it comes to the anti-vaccine current become enormously devastating. The doctor’s facts turned into discovered fraudulent and falsified, and he changed into eventually stripped of his clinical license. Scientists, medical doctors, and clinical experts had a splendid time; they notion an age of misconception involving vaccination was ending in state of starting.

despite these findings and former Dr. Wakefield’s finished necessity of credibility, frequent anti-vaccine figures corresponding to Jenny McCarthy create concept in these findings. McCarthy, mom of an autistic son, has been using her infant’s analysis as a artery to win public attention within the anti-vaccination stream. She claims that inoculating her child ended in his autism. McCarthy quickly grew to become one of the vital biggest anti-vaccination advocates within the united states, with not any practicable facts in the back of her autism-vaccine link. This link is a logical fallacy, where a correlation between vaccination and autism is assumed only because both are latest in a child. basically, McCarthy’s son may additionally hold autism for another reason--McCarthy’s behaviors and addictions earlier than pregnancy. Maternal drug abuse is without delay correlated with autism in infants, which Jenny McCarthy become extreme too proud to advertise before and during her misconception-propelled anti-vaccination crusade began. for example, McCarthy mentioned herself as a “convalescing Catholic,” after trying every thing from ecstasy to prescription drugs and eventually getting hooked on Vicodin. These medication in reality had a terrible hold an impact on on McCarthy’s son as a starting to live fetus (Marcus). even though it can not live mentioned for confident that her addictions ended in his autism, that controversy is tons extra plausible than the one accusing vaccinations. The AAP, or American Academy of Pediatrics, published in a finished vaccine-autism analysis paper, “studies don't array any hyperlink between autism and MMR vaccine, thimerosal, dissimilar vaccines given without delay, fevers or seizures” (“Vaccines”). Autism Speaks, a charity revolving around enhancing the pleasant of lifestyles for children and adults diagnosed with autism, claimed, “each and every household has a different journey with an autism prognosis, and for some it corresponds with the timing of their infant’s vaccinations. The results of...analysis is clear: Vaccines attain not trigger autism” (“What causes Autism?”). clearly, credible sources hold denounced the autism-vaccine link as non-existent; even if infants are diagnosed with autism around the very time as they're initially inoculated, the two aren’t correlated.

There are absolutely aspect consequences to immunization, however they don’t compare to the catastrophic consequences of contracting a lethal virus. about 1 in 3 americans record headaches following vaccination, and 1 in one hundred even complain of a tall fever as a side effect. having said that, illnesses that vaccines avoid, equivalent to measles, hold enormously worse and continually deadly penalties. A measles contraction begins with a rash that slowly spreads through the complete physique. as the rash progresses, the infected hold extraordinarily inordinate fevers. Their immune system weakens and that they circle into more prostrate to other lethal infections. within the early 2000s, best about 37 people in the u.s. died from measles yearly. lately, because of the anti-vaccine there had been well-nigh 650 situations in a 12 months (“Measles”). Minimal aspect consequences of vaccination can't start to examine to the devastating penalties of contracting mortal ailments.

Paul Offit, in his ebook lethal decisions: How the Anti-Vaccine movement Threatens Us All, asserts that actions in opposition t vaccination are misinformed and consequently defective to the neatly-being of society. Offit, a scientific medical professional, intelligently refutes every practicable controversy made in opposition t vaccination, provides a lot of anecdotes, and supports every declare he makes with plenty of scientific evidence. He eliminates extreme arguments against vaccination with a purpose to t halt parents from being misinformed when choosing whether or no longer to vaccinate, as well as to discourage the extra unfold of anti-vaccine propaganda on media structures. Offit makes an attempt to convince the universal public to gain recommended decisions with their babies by means of warning them about the tragic penalties in the event that they don’t. during his e-book, Offit presents scientists which hold made strides towards precisely informing the public about inoculation. Samuel Berkovic, a neurologist, realized the existence of a hyperlink between Dravet’s Syndrome and epilepsy following vaccinations. This discovery undermined each media figure, reminiscent of Lea Thompson, who claimed that vaccinations brought about seizures. Berkovic, however, didn’t regain the cognizance he deserved for this astounding clinical link in 2006. The neurologists and other recommended medical doctors that labored with him diagnosed his labor as whatever outstanding, however the americans circulating anti-vaccination propaganda persevered their fight regardless of it all. Rorke-Adams, another scientist outlined by artery of Offit in his analysis, examined over thirty infants whose fogeys claimed had seizures after vaccinations; every sole newborn she examined ended up having a special purpose at the back of the epilepsy, starting from vascular problems to degenerative diseases. As Offit brought up, “...regardless of her skills, and despite the fact that she has supported her reviews with cogent, neatly-researched opinions, Rorke-Adams often finds that petitioners live triumphant” (Offit 90).

different types of vaccines are administered reckoning on the age and maturity stage of the child. in consequence, herd immunity plays an incredibly essential position before the infant can receive the shot. Herd immunity, besides called community immunity, happens when ample americans in a bunch are vaccinated in order that the few that aren’t will even live blanketed. despite the fact, as the amount of americans not vaccinating grows extremely, herd immunity decreases on the very price. Physicians Phoebe Day Danzinger and Rebekah Diamond propose an extreme solution: don’t supply the anti-vaxxers a call. both doctors wrote, “Neither of us imagined they might relegate so a splendid deal of their time to working with parents who withstand what's arguably the very most useful invention of concomitant medication” (Danzinger and Diamond). moreover, they declar why there should noiseless live no inoculation exemptions, inspite of very own selection or values. The reality is that these illnesses deliver each person at risk, seeing that immunity is simply a cogent conception when satisfactory americans are immunized. This proposition is one feasible respond to the possibility of losing neighborhood immunity extreme over the state the united states.

Some propose a divorce answer: inform fogeys earlier than their infants are born to give them a far better probability of constructing informed selections in terms of immunization. Matthew Daley and Jason Glanz, of their Scientific American article “Straight talk about Vaccination,” accept as honest with loads of the artery to inform parents in regards to the weight of vaccination. This includes encouraging a prenatal class or proposing a forum for folks to dispute the vicissitude amongst themselves. the most practicable notion, although, is deciding a far better manner for docs to schedule visits to wholly deliver parents with information about vaccination. Daley and Glanz besides imply scheduling divorce visits for common prenatal checkups and vaccine advice classes. this is able to permit docs to rob extra time carefully explaining why inoculation shouldn’t live taken lightly. They additionally well known that commonly times, misinformation isn’t the fogeys’ fault, but the media and influences they’ve been surrounded with. therefore, it is the responsibility of medical gurus to attend cease the unfold of misconceptions.

1796 changed into one of the vital crucial years in scientific history when the first vaccine got here into existence. Its existence for the previous pair of centuries has shifted public view of it for the more serious. A terrible stigma now surrounds the live alert vaccination, as if it’s whatever thing perilous and deadly, in state of the illnesses it prevents. a lot of doctors, together with Paul Offit, Rorke-Adams, Day Danzinger, and Rebekah Diamond hold heavily recommended for inoculation as a means to hold epidemics from going on. specialists outweigh the credibility of the likes of Jenny McCarthy and Dr. Oz, who hold been staid promoters of the anti-vaccine circulate. Vaccination is and remains fundamental in widespread life, from conserving herd immunity to guaranteeing the safety of babies from resurfacing deadly diseases and infections. ordinary, the anti-vaccination current is one sparked via misconceptions and misinformation that should live stopped to retain babies suit and the realm epidemic-free.

Works CitedDaley, Matthew F., and Jason M. Glanz. "Straight talk about Vaccination." Scientific American. 11 Aug. 2011. web. 30 Mar. 2017.Danziger, Phoebe Day, and Rebekah Diamond. "we can’t convince Anti-Vaxxers of Science. They deserve to Mandate Vaccination."Slate magazine. 25 July 2016. web. 29 Mar. 2017.Marcus, Stephanie. "Jenny McCarthy Ecstasy: Actress Tried To hold sex With A Tree while On Ecstasy." The Huffington post. TheHuffingtonPost, 09 Nov. 2012. net. 28 Mar. 2017."Measles." KidsHealth. Ed. Scott A. Barron. The Nemours groundwork, Feb. 2015. net. 29 Mar. 2017."Measles cases and Outbreaks." facilities for disease manipulate and Prevention. centers for disease manipulate and Prevention, 06 Mar. 2017. net. 27 Mar. 2017.Offit, Paul A. lethal selections: How the Anti-vaccine stream Threatens Us All. manhattan: fundamental , a Member of the Persecus book group, 2015. Print."viable aspect-consequences from Vaccines." centers for disease manipulate and Prevention. facilities for ailment manipulate and Prevention, 02 Dec. 2016. net. 29 Mar. 2017.U.S. branch of health and Human functions. "Vaccines" Vaccines. U.S. department of health and Human services, 11 Oct. 2006. internet. 29 Mar. 2017."Vaccines trigger Seizures?: Samuel Berkovic, An Unsung Hero." Parenting Patch. 02 Dec. 2013. net. 29 Mar. 2017.Wakefield, Andrew. "Ileal-lymphoid-nodular Hyperplasia, Non-specific Colitis, and Pervasive Developmental ailment in infants." The Lancet. Elsevier restrained, 28 Feb. 1998. web. 27 Mar. 2017."What causes Autism?" Autism Speaks. 24 July 2012. web. 29 Mar. 2017.


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FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients | killexams.com actual questions and Pass4sure dumps

SILVER SPRING, Md., June 22, 2018 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration permitted marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who necessity hemodialysis. 

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

Specifically, the FDA granted marketing authorization for the disburse of the Ellipsys Vascular Access System and the everlinQ endoAVF System to gain what's called an arteriovenous (AV) fistula for patients who necessity hemodialysis access.

"Dialysis is a necessary and life-saving procedure for thousands of individuals. With today's action, there will live additional, less-invasive vascular access options for patients who will require hemodialysis," said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA's center for Devices and Radiological Health.

According to the National Institutes of Health, more than 661,000 Americans hold kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis utilizes a dialyzer, or ersatz kidney, to filter a patient's blood outside of their body. Before patients can start dialysis, however, they necessity to hold an AV fistula created. An AV fistula is traditionally made by surgically joining an artery and a vein under the skin in the arm. After some time, the age vein can then receive the two needles used for each hemodialysis session. Surgically created AV fistulas typically rob several months to heal and for the vein to age before being usable for hemodialysis.

The devices granted marketing authorization today are designed to create AV fistulas percutaneously (through the skin). A catheter is inserted into a blood vessel in the arm and is guided to the site of the planned AV fistula. The devices then deliver energy to shape a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular Access System uses one catheter, the everlinQ endoAVF System uses two.

For the Ellipsys Vascular Access System, the FDA reviewed data from a non-randomized, multi-center study of 103 patients. The Ellipsys Vascular Access System was used in a procedure to create an AV fistula in these patients, of which 92 patients (89.3 percent) met the criteria for a usable AV fistula within three months after the procedure.  Almost extreme patients (96.1 percent) required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.

For the everlinQ endoAVF System, the FDA reviewed data from a non-randomized, multi-center study of 60 patients, in addition to supporting data from three other studies and clinical disburse of the device outside the U.S. The everlinQ endoAVF System was used in a procedure to create an AV fistula in these patients. In the main study, 52 patients (86.7 percent) met the criteria for a usable AV fistula within three months after the procedure.  Almost extreme patients (96.7 percent) required an additional procedure at the time the fistula was created, while 28.3 percent of patients required an additional procedure (such as balloon angioplasty) in the first 12 months to maintain the fistula.

Both devices are contraindicated, or should not live used, for creation of anastomoses (connections) in vessels that are less than two millimeters in diameter or too far apart (for example, in the wrist or in the hand). For both devices, complications comprehend blocking (occlusion) or collapse (stenosis) of the fistula, bruising and necessity for additional procedures.

The Ellipsys Vascular Access System and everlinQ endoAVF System were reviewed through the De Novo premarket review pathway, a regulatory pathway for some low to temper risk devices of a novel type. This action besides creates a novel regulatory classification, which means that subsequent devices with the very intended disburse may evanesce through the FDA's 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Ellipsys Vascular Access System to Avenu Medical.

The FDA granted marketing authorization of the everlinQ endoAVF System to TVA Medical, Inc.

More information:FDA: Recently Approved DevicesFDA: De novo pathwayNIH: Hemodialysis

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency besides is responsible for the safety and security of their nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Caccomo, 301-348-1956, stephanie.caccomo@fda.hhs.gov  Consumer Inquiries: 888-INFO-FDA

Cision View original content with multimedia:https://www.prnewswire.com/news-releases/fda-permits-marketing-of-first-catheter-based-systems-used-to-create-vascular-access-for-hemodialysis-patients-300670882.html

SOURCE U.S. Food and Drug Administration


Marlborough Home to Nearly 40 Life Sciences Companies | killexams.com actual questions and Pass4sure dumps

This post was contributed by a community member.

It is probably a slight known fact that Marlborough is home to about 40 companies involved in the life sciences arena. Life Sciences is broadly defined as companies engaged in the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, biomedical devices, and organizations and institutions involved primarily in various stages of research, development, technology transfer and commercialization.

While Marlborough, whose location midway between the recognized life sciences hubs of Cambridge and Worcester, may not yet live on the map, the presence of this cluster of companies engaged in a wide sweep of cutting edge technology and  innovation activities makes Marlborough a contender for a piece of the Massachusetts life sciences pie.

Well established, leading life sciences players with operations in Marlborough comprehend Boston Scientific, Hologic, Rohm & Haas (Dow Chemicals) and Sunovion. These are mammoth international players with large employee bases and worldwide operations. However, enjoy many other companies they chose Marlborough because of its central location with facile highway access to the surrounding novel England states and its large labor pool. And they elect to sojourn here because actual estate prices are reasonable and there is leeway for expansion and growth.

Next, there is an impressive number of perhaps lesser known companies whose products and services contribute every day to medical and health care advancements, increased trait of life and improved life expectancy.  At the forefront of regenerative medicine is Advanced Cell Technology Inc., a company that specializes in the evolution of cellular therapies for the treatment of diseases and conditions that impact tens of millions of people worldwide.Company scientists are successfully generating human embryonic arise cell lines without destruction of the embryo.

CeQur Ltd is developing and commercializing advanced insulin delivery systems for ilk 2 Diabetes that can live easily integrated into daily life. They manufacture a small, wearable insulin delivery device that delivers both basal and bolus doses subcutaneously.

Having recently outgrown their space at the Mass biotechnical Incubator facility in Worcester, GlycoSolutions recently moved to Marlborough after finding good, cheap space in the city. The company, founded by Dr. Elizabeth Higgins, formerly of Genzyme, provides analytical advocate to companies developing therapeutic glycoproteins and monoclonal antibodies.

Iquum, Inc's proprietary lab-in-a-tube platform is the foundation of next generation tools for clinical diagnostics, therapeutic monitoring, biodefense, and agricultural and industrial biological sample testing.

Navilyst Medical, Inc. headquartered in Marlborough, delivers industry leading, best in class vascular access and fluid management technologies to the market today.Its products are used in 76 countries by healthcare providers, including interventional radiologists, interventional cardiologists, oncologists, surgeons, IV nurses, and oncology nurses.

Optos designs, develops, manufactures and markets retinal imaging devices that create optomap images.  The optomap is the only image that provides an ultra-wide 82% view of the retina.  A simple optomap scan is an famous appliance for the screening, early detection and diagnosis of eye problems such as retinal detachment, glaucoma, cataracts, retinal holes/retinal tears and age-related macular degeneration.

Oxford Immunotec, Inc. is developing novel novel tests for various diseases based on its innovative, patented T cell measurement technology. 

PointCare Technologies develops and markets innovative point-of-care diagnostic products, which target the hundreds of millions of people in resource-challenged developing nations who are vital with HIV/AIDS and other life-threatening infections and/or diseases.

Theracos Inc. which moved from Sunnyvale, CA to Marlborough in May is a pharmaceutical R&D company that develops, acquires, and supports research programs in inflammation, metabolism, and depression through global research activities

Xcellerex is commercializing turnkey biomanufacturing solutions that transform the precipitate and economics of producing therapeutic proteins, including biosimilars and vaccines. The company's FlexFactory® is a complete modular and portable production train based on single‐use technologies, advanced process automation, and compact spotless leeway architecture. Xcellerex recently sold a 2,000L FlexFactory® bioproduction line to Russian pharmaceutical company R‐Pharm for its novel biologics manufacturing facility in Yaroslavl, Russia.

In the biotechnology field, one Marlborough based company that has carved a niche for itself is Qteros, the developer of a unique and highly efficient Consolidated Bioprocessing (CBP) platform for converting non-food biomass into biofuels.Their mission is to accelerate the global commercialization of large-scale, lowest-cost cellulosic ethanol production.

Environmental engineering and services companies in Marlborough comprehend Capaccio Environmental Engineering, Enstrat Strategic Environmental Services, Tata & Howard, TRIDENT Environmental Group, LLC  and WaterSep Technology Corp.

Other life sciences companies in Marlborough comprehend 21st Century Biochemicals, Acton Pharmaceuticals, Inc., Acutest Labs (New England), Aspen Products Group, CardioFocus, Creganna Medical Devices, Physicians Interactive Holdings LLC, Protasis Corporation, Proveris Scientific Corporation, Skyscape, Inc., Spectra Analysis Inc., TDC Medical, and West River Pharmacy.

The Marlborough Economic evolution Corporation (MEDC) is in the midst of planning its second Annual  Innovation acme for late September which will provide an unique chance for these companies to meet, network and dispute the artery forward for Marlborough as a burgeoning life sciences hub.

For information about the upcoming acme contact info@marlboroughedc.com or summon 508 229 1010

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The Anti-Vaccination Movement: Spreading Misconceptions,Fueling Epidemics,Circulating Misinformation | killexams.com actual questions and Pass4sure dumps

“Outdated” diseases, such as measles, hold affected over 900 people in the past three years in the United States. “Informed” celebrities, such as Dr. Oz, hold spread misconceptions about autism in relation to vaccination. One thing’s for certain: “dangerous,” “unchecked,” and “useless” vaccinations are the reasons for the cease of polio, measles, smallpox, and pertussis epidemics. At the immediate of the 18th century, Edward Jenner invented the first vaccine by injecting cowpox-infected corporeal fluid into a boy that was infected with the disease. Ever since then, deadly diseases had preventions as soon as ethical, acceptable, and safe vaccines hit the market. For decades and even centuries, people felt privileged to hold access to this medical innovation that saved millions of lives internationally. Lately, however, preventable diseases unheard of in decades hold resurfaced as a result of the anti-vaccination movement. This movement resulted from citizens of first world countries taking this privilege for granted by believing that diseases such as measles were completely eradicated. Misconceptions about inoculation blew completely out of proportion, ranging from unscientific links with autism to fraudulent anecdotes and studies. Consequently, medical doctors such as Paul Offit hold dedicated their lives to eliminating the negative stigma that frequently surrounds immunization. The anti-vaccination movement, fueling misconceptions and catastrophically harming children, threatens the well-being of society. Vaccinations must live reinstated as one of the most valuable and vital modern-day developments of mankind to forestall further denouncement and devaluation incited by skeptics.

On February 28, 1998, an article was published in The Lancet titled, “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children”Wakefield). The doctor behind the article, Andrew Wakefield, was undoubtedly the man that sparked the autistic side of the anti-vaccine movement. Wakefield was the first to ever publish a study that showed a correlation between autism and vaccination. This experiment was completely disproved and even retracted by the Lancet, but its impact in terms of the anti-vaccine movement was incredibly devastating. The doctor’s data was create fraudulent and falsified, and he was ultimately stripped of his medical license. Scientists, doctors, and medical professionals rejoiced; they thought an era of misconception regarding vaccination was ending rather than beginning.

Despite these findings and former Dr. Wakefield’s complete necessity of credibility, approved anti-vaccine figures such as Jenny McCarthy create inspiration in these findings. McCarthy, mother of an autistic son, has been using her child’s diagnosis as a means to win public attention in the anti-vaccination movement. She claims that inoculating her child led to his autism. McCarthy soon became one of the biggest anti-vaccination advocates in the United States, without any feasible evidence behind her autism-vaccine link. This link is a logical fallacy, where a correlation between vaccination and autism is assumed only because both are present in a child. In fact, McCarthy’s son may hold autism for another reason--McCarthy’s behaviors and addictions before pregnancy. Maternal drug abuse is directly correlated with autism in babies, which Jenny McCarthy was extreme too proud to advertise before and during her misconception-propelled anti-vaccination campaign started. For instance, McCarthy referred to herself as a “recovering Catholic,” after trying everything from ecstasy to prescription pills and ultimately getting hooked on Vicodin. These drugs definitely had a negative influence on McCarthy’s son as a growing fetus (Marcus). Although it cannot live stated for confident that her addictions led to his autism, that controversy is much more plausible than the one accusing vaccinations. The AAP, or American Academy of Pediatrics, published in a comprehensive vaccine-autism research paper, “Studies attain not array any link between autism and MMR vaccine, thimerosal, multiple vaccines given at once, fevers or seizures” (“Vaccines”). Autism Speaks, a charity revolving around improving the trait of life for children and adults diagnosed with autism, claimed, “Each family has a unique smack with an autism diagnosis, and for some it corresponds with the timing of their child’s vaccinations. The results of...research is clear: Vaccines attain not cause autism” (“What Causes Autism?”). Evidently, credible sources hold denounced the autism-vaccine link as non-existent; even though children are diagnosed with autism around the very time as they are initially inoculated, the two aren’t correlated.

There are undoubtedly side effects to immunization, but they don’t compare to the catastrophic consequences of contracting a deadly virus. Approximately 1 in 3 people report headaches following vaccination, and 1 in 100 even complain of a tall fever as a side effect. On the other hand, diseases that vaccines prevent, such as measles, hold incredibly worse and usually mortal consequences. A measles contraction starts with a rash that slowly spreads through the entire body. As the rash progresses, the infected hold extremely tall fevers. Their immune system weakens and they become more susceptible to other deadly infections. In the early 2000s, only about 37 people in the United States died from measles annually. Recently, due to the anti-vaccine there hold been almost 650 cases in a year (“Measles”). Minimal side effects of vaccination cannot originate to compare to the devastating consequences of contracting mortal diseases.

Paul Offit, in his book Deadly Choices: How the Anti-Vaccine Movement Threatens Us All, asserts that movements against vaccination are misinformed and consequently perilous to the well-being of society. Offit, a medical doctor, intelligently refutes every practicable controversy made against vaccination, provides a variety of anecdotes, and supports every pretense he makes with plenty of scientific evidence. He eliminates extreme arguments against vaccination in order to t halt parents from being misinformed when choosing whether or not to vaccinate, as well as to discourage the further spread of anti-vaccine propaganda on media platforms. Offit attempts to convince the public to gain informed decisions with their children by warning them about the tragic consequences if they don’t. Throughout his book, Offit presents scientists that hold made strides towards accurately informing the public about inoculation. Samuel Berkovic, a neurologist, realized the existence of a link between Dravet’s Syndrome and epilepsy following vaccinations. This discovery undermined every media figure, such as Lea Thompson, who claimed that vaccinations caused seizures. Berkovic, however, didn’t regain the recognition he deserved for this brilliant medical link in 2006. The neurologists and other informed doctors that worked with him recognized his labor as something remarkable, but the people circulating anti-vaccination propaganda continued their fight despite it all. Rorke-Adams, another scientist mentioned by Offit in his research, examined over thirty children whose parents claimed had seizures after vaccinations; every sole child she examined ended up having a different reason behind the epilepsy, ranging from vascular disorders to degenerative diseases. As Offit stated, “...despite her expertise, and despite the fact that she has supported her evaluations with cogent, well-researched opinions, Rorke-Adams often finds that petitioners prevail” (Offit 90).

Different types of vaccines are administered depending on the age and maturity even of the child. As a result, herd immunity plays an incredibly famous role before the child can receive the shot. Herd immunity, besides known as community immunity, occurs when enough people in a group are vaccinated so that the few that aren’t will besides live protected. However, as the amount of people not vaccinating grows tremendously, herd immunity decreases at the very rate. Physicians Phoebe Day Danzinger and Rebekah Diamond propose an extreme solution: don’t give the anti-vaxxers a choice. The two doctors wrote, “Neither of us imagined they would dedicate so much of their time to working with parents who withstand what is arguably the very greatest invention of modern medicine” (Danzinger and Diamond). Furthermore, they declar why there should live no inoculation exemptions, regardless of personal preference or values. The verity is that these diseases deliver everyone at risk, since immunity is only a cogent concept when enough people are immunized. This proposition is one practicable solution to the threat of losing community immunity extreme over the United States.

Some propose a different solution: inform parents before their children are born to give them a better chance of making informed decisions in terms of immunization. Matthew Daley and Jason Glanz, in their Scientific American article “Straight Talk about Vaccination,” deem a variety of ways to inform parents about the weight of vaccination. This includes encouraging a prenatal class or providing a forum for parents to dispute the issue amongst themselves. The most feasible proposal, however, is figuring out a better artery for doctors to schedule visits to fully provide parents with information about vaccination. Daley and Glanz besides suggest scheduling divorce visits for standard prenatal checkups and vaccine information sessions. This would allow doctors to rob more time carefully explaining why inoculation shouldn’t live taken lightly. They besides admit that often times, misinformation isn’t the parents’ fault, but the media and influences they’ve been surrounded with. Therefore, it is the responsibility of medical professionals to attend halt the spread of misconceptions.

1796 was one of the most famous years in medical history when the first vaccine came into existence. Its existence for the past pair of centuries has shifted public view of it for the worse. A negative stigma now surrounds the word vaccination, as if it’s something perilous and fatal, rather than the diseases it prevents. Plenty of doctors, including Paul Offit, Rorke-Adams, Day Danzinger, and Rebekah Diamond hold heavily advocated for inoculation as a means to hold epidemics from happening. Professionals outweigh the credibility of the likes of Jenny McCarthy and Dr. Oz, who hold been staid promoters of the anti-vaccine movement. Vaccination is and continues to live essential in everyday life, from protecting herd immunity to ensuring the safety of children from resurfacing mortal diseases and infections. Overall, the anti-vaccination movement is one sparked by misconceptions and misinformation that must live stopped to hold children robust and the world epidemic-free.

Works CitedDaley, Matthew F., and Jason M. Glanz. "Straight Talk about Vaccination." Scientific American. 11 Aug. 2011. Web. 30 Mar. 2017.Danziger, Phoebe Day, and Rebekah Diamond. "We Can’t Convince Anti-Vaxxers of Science. They necessity to Mandate Vaccination."Slate Magazine. 25 July 2016. Web. 29 Mar. 2017.Marcus, Stephanie. "Jenny McCarthy Ecstasy: Actress Tried To hold Sex With A Tree While On Ecstasy." The Huffington Post. TheHuffingtonPost, 09 Nov. 2012. Web. 28 Mar. 2017."Measles." KidsHealth. Ed. Scott A. Barron. The Nemours Foundation, Feb. 2015. Web. 29 Mar. 2017."Measles Cases and Outbreaks." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 06 Mar. 2017. Web. 27 Mar. 2017.Offit, Paul A. Deadly Choices: How the Anti-vaccine Movement Threatens Us All. novel York: Basic , a Member of the Persecus book Group, 2015. Print."Possible Side-effects from Vaccines." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 02 Dec. 2016. Web. 29 Mar. 2017.U.S. Department of Health and Human Services. "Vaccines" Vaccines. U.S. Department of Health and Human Services, 11 Oct. 2006. Web. 29 Mar. 2017."Vaccines cause Seizures?: Samuel Berkovic, An Unsung Hero." Parenting Patch. 02 Dec. 2013. Web. 29 Mar. 2017.Wakefield, Andrew. "Ileal-lymphoid-nodular Hyperplasia, Non-specific Colitis, and Pervasive Developmental Disorder in Children." The Lancet. Elsevier Limited, 28 Feb. 1998. Web. 27 Mar. 2017."What Causes Autism?" Autism Speaks. 24 July 2012. Web. 29 Mar. 2017.



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MORGAN Studio

is specialized in Architectural visualization , Industrial visualization , 3D Modeling ,3D Animation , Entertainment and Visual Effects .