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VACC exam Dumps Source : VACC Vascular Access

Test Code : VACC
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 build 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 simultaneous action, there should breathe extra, less-invasive vascular entry alternatives for sufferers who will require hemodialysis," illustrious 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 luxuriate in kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis makes exhaust of a dialyzer, or synthetic kidney, to filter a patient's blood outside of their body. before sufferers can birth dialysis, youngsters, they exigency to luxuriate in 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 ripen vein can then obtain the two needles used for each and every hemodialysis session. Surgically created AV fistulas typically ensnare a number of months to heal and for the vein to ripen 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 profile a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular access paraphernalia makes exhaust of one catheter, the everlinQ endoAVF system makes exhaust 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 consummate 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 dissect of 60 patients, apart from helping records from three other studies and medical exhaust 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 entire spy at, fifty two sufferers (86.7 percent) met the criteria for a usable AV fistula within three months after the technique.  just about consummate 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 breathe 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 average possibility gadgets of a brand newfangled classification. This motion too creates a brand newfangled regulatory classification, which means that subsequent gadgets with the identical reputed exhaust might too proceed 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 too 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


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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 silent luxuriate in cause of difficulty about indicators like the telltale measles rash: In 2018, there luxuriate in 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 accumulate 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 illustrious Persian doctor Rhazes. there luxuriate in been primary 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 confidence die of the measles yearly.

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

The sickness is led to with the aid of the unfold of a sort of virus called morbillivirus, which will too breathe 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 breathe standing subsequent to someone with the measles to accumulate it from them.

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

a person uncovered to measles will start to panoply 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 hold 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 compress an ear an infection, perhaps resulting in permanent listening to harm, and one in 20 will accumulate pneumonia. One or two out of every 1000 youngsters who compress 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 breathe tremendously valuable. experts intimate that infants accumulate their first dose of the MMR vaccine on their first birthday (however not before). Then, they should silent accumulate the 2d dose before they enter kindergarten. If a toddler doesn’t accumulate vaccinated before they’re 12, they may silent nevertheless accumulate the vaccine: two doses a month aside. In most cases, these two doses of the vaccine may silent breathe adequate to present you immunity for life (youngsters some experts are now cautioning booster shots may breathe a advantageous understanding 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 accumulate 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 breathe eradicated throughout the entire thing of North and South the usa.

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

Measles isn’t well-liked within the U.S., however that doesn’t finger you could bypass your vaccinations: although domestic-grown measles has been eradicated, americans within the U.S. silent near down with it. That’s because measles is silent a vast difficulty 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 proceed back and forth, “infants 6 months through eleven months of age should silent receive one dose of MMR vaccine” after which accumulate a shot once again once they’re a minute older). That makes it tremendously crucial for everybody round them to breathe 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, like babies, or individuals whose bodies didn’t reply to the vaccine for anything rationale.

7. individuals silent accumulate 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 luxuriate in caught the sickness during the past few years. In 2004, there luxuriate in been just 37 cases of measles said in the U.S. Ten years later, in 2014, there luxuriate in been 667—most of whom were people who weren’t vaccinated. (That number become surprisingly excessive, and went prerogative down to 188 situations the subsequent year.)

The CDC blames simultaneous measles outbreaks on low quotes of vaccination. One 2016 evaluation of measles experiences establish 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 too 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 uncertain information for americans, too, on account that most U.S. measles instances may too breathe linked returned to travelers coming into the U.S. from places like Europe. So accumulate 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, luxuriate in affected over 900 americans during the past three years in the u.s.. “informed” celebrities, similar to Dr. Oz, luxuriate in spread misconceptions about autism relating to vaccination. One factor’s for definite: “bad,” “unchecked,” and “useless” vaccinations are the factors for the End of polio, measles, smallpox, and pertussis epidemics. on the near of the 18th century, Edward Jenner invented the first vaccine by pass of injecting cowpox-infected somatic fluid prerogative 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 luxuriate in access to this medical innovation that saved thousands and thousands of lives internationally. currently, youngsters, preventable diseases unparalleled in a long time luxuriate in 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 pass of believing that diseases such as measles luxuriate in 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 luxuriate in 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 breathe 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 dissect that confirmed a correlation between autism and vaccination. This test become absolutely disproved and even retracted through the Lancet, however its luxuriate in an repercussion on when it comes to the anti-vaccine flux 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 advantageous time; they notion an era of misconception involving vaccination was ending in region of starting.

despite these findings and former Dr. Wakefield’s finished lack of credibility, frequent anti-vaccine figures corresponding to Jenny McCarthy establish concept in these findings. McCarthy, mom of an autistic son, has been using her infant’s analysis as a system 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 one feasible facts in the back of her autism-vaccine link. This link is a rational fallacy, where a correlation between vaccination and autism is assumed only because both are latest in a child. basically, McCarthy’s son may additionally luxuriate in autism for another reason--McCarthy’s behaviors and addictions earlier than pregnancy. Maternal drug maltreat is without detain correlated with autism in infants, which Jenny McCarthy become consummate too arrogant 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 luxuriate in an repercussion on on McCarthy’s son as a starting to breathe fetus (Marcus). even though it can not breathe mentioned for certain that her addictions ended in his autism, that argument is tons extra credible than the one accusing vaccinations. The AAP, or American Academy of Pediatrics, published in a finished vaccine-autism analysis paper, “studies don't panoply 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 effect not trigger autism” (“What causes Autism?”). clearly, credible sources luxuriate in denounced the autism-vaccine link as non-existent; even if infants are diagnosed with autism around the identical 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 lofty fever as a side effect. having said that, illnesses that vaccines avoid, equivalent to measles, luxuriate in 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 luxuriate in extraordinarily extravagant fevers. Their immune system weakens and that they revolve into more supine 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 deadly 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 faulty to the neatly-being of society. Offit, a scientific medical professional, intelligently refutes every feasible argument made in opposition t vaccination, provides a lot of anecdotes, and supports every declare he makes with plenty of scientific evidence. He eliminates consummate arguments against vaccination with a purpose to t cease parents from being misinformed when choosing whether or no longer to vaccinate, as well as to dispirit the extra unfold of anti-vaccine propaganda on media structures. Offit makes an attempt to induce the universal public to build 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 luxuriate in made strides towards precisely informing the public about inoculation. Samuel Berkovic, a neurologist, realized the being 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 accumulate the cognizance he deserved for this astounding clinical link in 2006. The neurologists and other recommended medical doctors that labored with him diagnosed his travail as whatever outstanding, however the americans circulating anti-vaccination propaganda persevered their fight regardless of it all. Rorke-Adams, another scientist outlined by pass of Offit in his analysis, examined over thirty infants whose fogeys claimed had seizures after vaccinations; every single 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 breathe 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, too called community immunity, happens when ample americans in a bunch are vaccinated in order that the few that aren’t will even breathe blanketed. despite the fact, as the amount of americans not vaccinating grows extremely, herd immunity decreases on the identical 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 confide so a advantageous deal of their time to working with parents who withstand what's arguably the very most useful invention of simultaneous medication” (Danzinger and Diamond). moreover, they aver why there should silent breathe no inoculation exemptions, inspite of very own selection or values. The reality is that these illnesses reserve each person at risk, seeing that immunity is simply a valid conception when satisfactory americans are immunized. This proposition is one feasible reply to the possibility of losing neighborhood immunity consummate over the region the united states.

Some propose a distinct 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 dependable with loads of the pass to inform parents in regards to the minute of vaccination. This includes encouraging a prenatal class or proposing a forum for folks to argue the difficulty amongst themselves. the most feasible notion, although, is deciding a far better manner for docs to schedule visits to wholly deliver parents with information about vaccination. Daley and Glanz too imply scheduling sunder visits for common prenatal checkups and vaccine recommendation classes. this is able to permit docs to ensnare extra time carefully explaining why inoculation shouldn’t breathe 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 wait on 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 being for the previous brace of centuries has shifted public view of it for the more serious. A terrible stigma now surrounds the breathe cognizant vaccination, as if it’s whatever thing uncertain and deadly, in region of the illnesses it prevents. a lot of doctors, together with Paul Offit, Rorke-Adams, Day Danzinger, and Rebekah Diamond luxuriate in heavily recommended for inoculation as a means to preserve epidemics from going on. specialists outweigh the credibility of the likes of Jenny McCarthy and Dr. Oz, who luxuriate in been sober 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 flux is one sparked via misconceptions and misinformation that should breathe 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 luxuriate in 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 handle and Prevention. centers for disease handle 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 engage group, 2015. Print."viable aspect-consequences from Vaccines." centers for disease handle and Prevention. facilities for ailment handle and Prevention, 02 Dec. 2016. net. 29 Mar. 2017.U.S. offshoot 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 confirmed kidney disease who exigency hemodialysis. 

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

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

"Dialysis is a necessary and life-saving procedure for thousands of individuals. With today's action, there will breathe 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 headquarters for Devices and Radiological Health.

According to the National Institutes of Health, more than 661,000 Americans luxuriate in kidney failure, of which approximately two-thirds are on hemodialysis. Hemodialysis utilizes a dialyzer, or synthetic kidney, to filter a patient's blood outside of their body. Before patients can start dialysis, however, they exigency to luxuriate in 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 ripen vein can then receive the two needles used for each hemodialysis session. Surgically created AV fistulas typically ensnare several months to heal and for the vein to ripen 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 profile 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 consummate 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 exhaust 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 consummate 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 breathe 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 comprise blocking (occlusion) or collapse (stenosis) of the fistula, bruising and exigency 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 qualify risk devices of a newfangled type. This action too creates a newfangled regulatory classification, which means that subsequent devices with the identical intended exhaust may proceed 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 too is answerable 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 minute 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 breathe on the map, the presence of this cluster of companies engaged in a wide purview 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 comprise Boston Scientific, Hologic, Rohm & Haas (Dow Chemicals) and Sunovion. These are vast international players with big employee bases and worldwide operations. However, like many other companies they chose Marlborough because of its central location with smooth highway access to the surrounding newfangled England states and its big 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 confidence advancements, increased character 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 repercussion tens of millions of people worldwide.Company scientists are successfully generating human embryonic issue cell lines without destruction of the embryo.

CeQur Ltd is developing and commercializing advanced insulin delivery systems for kind 2 Diabetes that can breathe 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 primary implement 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 newfangled 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 animate 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 hasten 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 clean leeway architecture. Xcellerex recently sold a 2,000L FlexFactory® bioproduction line to Russian pharmaceutical company R‐Pharm for its newfangled 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 comprise Capaccio Environmental Engineering, Enstrat Strategic Environmental Services, Tata & Howard, TRIDENT Environmental Group, LLC  and WaterSep Technology Corp.

Other life sciences companies in Marlborough comprise 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 peak for late September which will provide an unique break for these companies to meet, network and argue the pass forward for Marlborough as a burgeoning life sciences hub.

For information about the upcoming peak contact info@marlboroughedc.com or convoke 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, luxuriate in affected over 900 people in the past three years in the United States. “Informed” celebrities, such as Dr. Oz, luxuriate in spread misconceptions about autism in relation to vaccination. One thing’s for certain: “dangerous,” “unchecked,” and “useless” vaccinations are the reasons for the End of polio, measles, smallpox, and pertussis epidemics. At the near of the 18th century, Edward Jenner invented the first vaccine by injecting cowpox-infected somatic 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 luxuriate in access to this medical innovation that saved millions of lives internationally. Lately, however, preventable diseases unheard of in decades luxuriate in 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 luxuriate in 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 breathe reinstated as one of the most valuable and vital modern-day developments of mankind to obviate 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 repercussion in terms of the anti-vaccine movement was incredibly devastating. The doctor’s data was establish 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 lack of credibility, well-liked anti-vaccine figures such as Jenny McCarthy establish 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 rational fallacy, where a correlation between vaccination and autism is assumed only because both are present in a child. In fact, McCarthy’s son may luxuriate in autism for another reason--McCarthy’s behaviors and addictions before pregnancy. Maternal drug maltreat is directly correlated with autism in babies, which Jenny McCarthy was consummate too arrogant to advertise before and during her misconception-propelled anti-vaccination drive 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 breathe stated for certain that her addictions led to his autism, that argument is much more credible than the one accusing vaccinations. The AAP, or American Academy of Pediatrics, published in a comprehensive vaccine-autism research paper, “Studies effect not attest 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 character of life for children and adults diagnosed with autism, claimed, “Each family has a unique experience with an autism diagnosis, and for some it corresponds with the timing of their child’s vaccinations. The results of...research is clear: Vaccines effect not cause autism” (“What Causes Autism?”). Evidently, credible sources luxuriate in denounced the autism-vaccine link as non-existent; even though children are diagnosed with autism around the identical 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 lofty fever as a side effect. On the other hand, diseases that vaccines prevent, such as measles, luxuriate in incredibly worse and usually deadly consequences. A measles contraction starts with a rash that slowly spreads through the entire body. As the rash progresses, the infected luxuriate in extremely lofty 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 luxuriate in been almost 650 cases in a year (“Measles”). Minimal side effects of vaccination cannot originate to compare to the devastating consequences of contracting deadly diseases.

Paul Offit, in his engage Deadly Choices: How the Anti-Vaccine Movement Threatens Us All, asserts that movements against vaccination are misinformed and consequently uncertain to the well-being of society. Offit, a medical doctor, intelligently refutes every feasible argument made against vaccination, provides a variety of anecdotes, and supports every pretense he makes with plenty of scientific evidence. He eliminates consummate arguments against vaccination in order to t cease parents from being misinformed when choosing whether or not to vaccinate, as well as to dispirit the further spread of anti-vaccine propaganda on media platforms. Offit attempts to induce the public to build informed decisions with their children by warning them about the tragic consequences if they don’t. Throughout his book, Offit presents scientists that luxuriate in made strides towards accurately informing the public about inoculation. Samuel Berkovic, a neurologist, realized the being 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 accumulate the recognition he deserved for this brilliant medical link in 2006. The neurologists and other informed doctors that worked with him recognized his travail 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 single child she examined ended up having a different judgement 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 primary role before the child can receive the shot. Herd immunity, too known as community immunity, occurs when enough people in a group are vaccinated so that the few that aren’t will too breathe protected. However, as the amount of people not vaccinating grows tremendously, herd immunity decreases at the identical 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 aver why there should breathe no inoculation exemptions, regardless of personal preference or values. The veracity is that these diseases reserve everyone at risk, since immunity is only a valid concept when enough people are immunized. This proposition is one feasible solution to the threat of losing community immunity consummate 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 minute of vaccination. This includes encouraging a prenatal class or providing a forum for parents to argue the issue amongst themselves. The most feasible proposal, however, is figuring out a better pass for doctors to schedule visits to fully provide parents with information about vaccination. Daley and Glanz too intimate scheduling sunder visits for touchstone prenatal checkups and vaccine information sessions. This would allow doctors to ensnare more time carefully explaining why inoculation shouldn’t breathe taken lightly. They too 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 wait on cease the spread of misconceptions.

1796 was one of the most primary years in medical history when the first vaccine came into existence. Its being for the past brace of centuries has shifted public view of it for the worse. A negative stigma now surrounds the word vaccination, as if it’s something uncertain and fatal, rather than the diseases it prevents. Plenty of doctors, including Paul Offit, Rorke-Adams, Day Danzinger, and Rebekah Diamond luxuriate in heavily advocated for inoculation as a means to preserve epidemics from happening. Professionals outweigh the credibility of the likes of Jenny McCarthy and Dr. Oz, who luxuriate in been sober promoters of the anti-vaccine movement. Vaccination is and continues to breathe essential in everyday life, from protecting herd immunity to ensuring the safety of children from resurfacing deadly diseases and infections. Overall, the anti-vaccination movement is one sparked by misconceptions and misinformation that must breathe stopped to preserve 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 exigency to Mandate Vaccination."Slate Magazine. 25 July 2016. Web. 29 Mar. 2017.Marcus, Stephanie. "Jenny McCarthy Ecstasy: Actress Tried To luxuriate in 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. newfangled York: Basic , a Member of the Persecus engage 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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IAAP [1 Certification Exam(s) ]
IAHCSMM [1 Certification Exam(s) ]
IBM [1532 Certification Exam(s) ]
IBQH [1 Certification Exam(s) ]
ICAI [1 Certification Exam(s) ]
ICDL [6 Certification Exam(s) ]
IEEE [1 Certification Exam(s) ]
IELTS [1 Certification Exam(s) ]
IFPUG [1 Certification Exam(s) ]
IIA [3 Certification Exam(s) ]
IIBA [2 Certification Exam(s) ]
IISFA [1 Certification Exam(s) ]
Intel [2 Certification Exam(s) ]
IQN [1 Certification Exam(s) ]
IRS [1 Certification Exam(s) ]
ISA [1 Certification Exam(s) ]
ISACA [4 Certification Exam(s) ]
ISC2 [6 Certification Exam(s) ]
ISEB [24 Certification Exam(s) ]
Isilon [4 Certification Exam(s) ]
ISM [6 Certification Exam(s) ]
iSQI [7 Certification Exam(s) ]
ITEC [1 Certification Exam(s) ]
Juniper [64 Certification Exam(s) ]
LEED [1 Certification Exam(s) ]
Legato [5 Certification Exam(s) ]
Liferay [1 Certification Exam(s) ]
Logical-Operations [1 Certification Exam(s) ]
Lotus [66 Certification Exam(s) ]
LPI [24 Certification Exam(s) ]
LSI [3 Certification Exam(s) ]
Magento [3 Certification Exam(s) ]
Maintenance [2 Certification Exam(s) ]
McAfee [8 Certification Exam(s) ]
McData [3 Certification Exam(s) ]
Medical [69 Certification Exam(s) ]
Microsoft [374 Certification Exam(s) ]
Mile2 [3 Certification Exam(s) ]
Military [1 Certification Exam(s) ]
Misc [1 Certification Exam(s) ]
Motorola [7 Certification Exam(s) ]
mySQL [4 Certification Exam(s) ]
NBSTSA [1 Certification Exam(s) ]
NCEES [2 Certification Exam(s) ]
NCIDQ [1 Certification Exam(s) ]
NCLEX [2 Certification Exam(s) ]
Network-General [12 Certification Exam(s) ]
NetworkAppliance [39 Certification Exam(s) ]
NI [1 Certification Exam(s) ]
NIELIT [1 Certification Exam(s) ]
Nokia [6 Certification Exam(s) ]
Nortel [130 Certification Exam(s) ]
Novell [37 Certification Exam(s) ]
OMG [10 Certification Exam(s) ]
Oracle [279 Certification Exam(s) ]
P&C [2 Certification Exam(s) ]
Palo-Alto [4 Certification Exam(s) ]
PARCC [1 Certification Exam(s) ]
PayPal [1 Certification Exam(s) ]
Pegasystems [12 Certification Exam(s) ]
PEOPLECERT [4 Certification Exam(s) ]
PMI [15 Certification Exam(s) ]
Polycom [2 Certification Exam(s) ]
PostgreSQL-CE [1 Certification Exam(s) ]
Prince2 [6 Certification Exam(s) ]
PRMIA [1 Certification Exam(s) ]
PsychCorp [1 Certification Exam(s) ]
PTCB [2 Certification Exam(s) ]
QAI [1 Certification Exam(s) ]
QlikView [1 Certification Exam(s) ]
Quality-Assurance [7 Certification Exam(s) ]
RACC [1 Certification Exam(s) ]
Real-Estate [1 Certification Exam(s) ]
RedHat [8 Certification Exam(s) ]
RES [5 Certification Exam(s) ]
Riverbed [8 Certification Exam(s) ]
RSA [15 Certification Exam(s) ]
Sair [8 Certification Exam(s) ]
Salesforce [5 Certification Exam(s) ]
SANS [1 Certification Exam(s) ]
SAP [98 Certification Exam(s) ]
SASInstitute [15 Certification Exam(s) ]
SAT [1 Certification Exam(s) ]
SCO [10 Certification Exam(s) ]
SCP [6 Certification Exam(s) ]
SDI [3 Certification Exam(s) ]
See-Beyond [1 Certification Exam(s) ]
Siemens [1 Certification Exam(s) ]
Snia [7 Certification Exam(s) ]
SOA [15 Certification Exam(s) ]
Social-Work-Board [4 Certification Exam(s) ]
SpringSource [1 Certification Exam(s) ]
SUN [63 Certification Exam(s) ]
SUSE [1 Certification Exam(s) ]
Sybase [17 Certification Exam(s) ]
Symantec [134 Certification Exam(s) ]
Teacher-Certification [4 Certification Exam(s) ]
The-Open-Group [8 Certification Exam(s) ]
TIA [3 Certification Exam(s) ]
Tibco [18 Certification Exam(s) ]
Trainers [3 Certification Exam(s) ]
Trend [1 Certification Exam(s) ]
TruSecure [1 Certification Exam(s) ]
USMLE [1 Certification Exam(s) ]
VCE [6 Certification Exam(s) ]
Veeam [2 Certification Exam(s) ]
Veritas [33 Certification Exam(s) ]
Vmware [58 Certification Exam(s) ]
Wonderlic [2 Certification Exam(s) ]
Worldatwork [2 Certification Exam(s) ]
XML-Master [3 Certification Exam(s) ]
Zend [6 Certification Exam(s) ]





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