June 25, 2018

Shingles on the Rise

Shingles on the Rise

Shingles is increasing in the United States, according to the Centers for Disease Control and Prevention (CDC), and health experts are not quite sure why.
A recent retrospective study of 2,848,765 Medicare claims showed the incidence of shingles increased 39 percent from 1992 to 2010.
About Shingles
shingles_frankmagliochettireportNearly a third people in the U.S. will develop shingles, otherwise known as herpes zoster or simply “zoster,” during their lifetime. While most people who get shingles will develop it only once but some get the disease two or three times. The risk of shingles increases with age, especially after the age of 50. Children can get shingles, but it is uncommon.
Signs and symptoms of shingles include pain, itching, or tingling of skin just before the development of a painful rash of blister-like sores. Symptoms typically develop on one side of the body, often on the face or torso. Fever, headache, chills, and upset stomach may occur. Severe pain in the affected area, known as postherpatic neuralgia (PHN), is the most common symptom of shingles.
Shingles develops as the result of exposure to the varicella zoster virus (VZV), which is the same virus that causes varicella disease, also known as chickenpox. The virus remains dormant sensory ganglia after the individual recovers from varicella; the virus can reactivate to cause shingles years later.
Are Chickenpox Vaccinations Accelerating the Increase of Shingles?
Researchers are still working to understand why the virus reactivates. It appears that an individual’s risk for shingles increases as immunity to VZV declines, as happens with aging or with the development of immunodeficiency associated with certain illnesses or treatments.
Some research suggests that exposure to varicella disease can actually boost immunity to VZV and reduce the risk for reactivation as shingles. Other research does not show this effect and the results “reflects the uncertain influence of varicella circulation on zoster epidemiology.”
Rates of chickenpox fell dramatically in the years following the implementation of the childhood varicella vaccination program in 1996, leading some scientists to speculate that the rise in shingles in adults was the result of childhood vaccination against varicella. These researchers reasoned that adults exposed to children with the virus would build immunity against varicella, and that widespread vaccination of children would provide fewer opportunities for adult exposure.
Results from a recent CDC study seem to disprove this theory. Researchers in that study used Medicare data from 1992 to 2010 and found that shingles rates shingles_frankmagliochetti-reportwere rising even before the introduction of the varicella vaccine in 1996. Furthermore, zoster rates did not accelerate after the introduction of the program.
The researchers in the CDC study also looked for any link between state varicella vaccination coverage and zoster rates, and found that the rates of shingles did not accelerate as states increased vaccination coverage. In fact, the incidence of shingles was the same in states with high vaccination coverage as it was in states with low coverage.
Furthermore, countries without routine varicella vaccination programs are experiencing similar increases in shingles rates in adults.
Like the wild-type virus that occurs in nature, the attenuated vaccine virus can reactivate to cause shingles. Children who get the varicella vaccine appear to have a much lower risk for childhood shingles than children infected with the wild-type virus. Vaccinated children are also less likely to be infected with the wild-type virus, which is more likely to reactivate as shingles as compared to the weakened vaccine virus.
While scientists have yet to discover the reasons behind the increased incidence of shingles, it is clear that zoster vaccination can prevent many cases of shingles, both in adults and in children.

Source
http://www.cdc.gov/shingles/surveillance.html
http://annals.org/aim/article/1784289/examination-links-between-herpes-zoster-incidence-childhood-varicella-vaccination
https://www.ncbi.nlm.nih.gov/pubmed/12057605
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2866606/
http://www.cdc.gov/mmwr/preview/mmwrhtml/00039897.htm
https://www.ncbi.nlm.nih.gov/pubmed/21217180

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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CDC Warns Against Using Nasal Spray Flu Vaccine

CDC Recommends Not Using Nasal Spray Flu Vaccine for 2016/2017 Season

Frank Magliochetti Report

The Centers for Disease Control and Prevention (CDC) has issued its 2016-2017 influenza vaccination recommendations, which includes the use of inactivated influenza vaccine (IIV) and the recombinant influenza vaccine (RIV). One of the most notable changes to the yearly recommendations is that the CDC is not recommending the use of nasal spray flu vaccinations using live attenuated frankmagliochetti-report_flu-shot-vaccineinfluenza vaccine (LAIV) during 2016-2017, as studies show it is not effective against preventing the flu.
The studies show LAIV had no protective benefit from children ages 2 to 17. In contrast, children who received an injection were 63 percent less likely to catch influenza than are those who received no vaccination at all.
While researchers have not yet determined the underlying cause of the loss of efficacy, but it could be due to changes in the dominant viral strains circulating in the nation during flu season. LAIV worked just as well as the shot at protecting children from H3N3 and the influenza B strain in recent flu seasons, according to a study published in the journal Pediatrics, but youngsters who received LAIV were three times more likely to suffer infection with H1N1 than were children who got the shot.
H1N1 has been the dominant strain for the past few years, according to a February 2016 CDC report, which means LAIVs can leave patients unprotected from the strains most likely to cause illness this flu season.

About Vaccinations, LAIVs, and Flu Season

Influenza vaccinations protect millions of people in the United States from developing influenza each year. Flu shots also reduce severity of influenza symptoms when it does develop, and prevents cdc-frankmagliochettireporthospitalizations relating to the flu. CDC recommends yearly flu shots for everyone 6 months and older. Antibodies typically take about two weeks to develop.
Many patients, and parents of pediatric patients, prefer LAIVs because of the perceived pain or trauma of an injection. LAIVs have been under development in the United States since the 1960s, according to the CDC, and the intranasal, trivalent, cold-adapted, live, LAIV received approval in 2003 as an option for among health patients aged 5 to 49 years. Because the nasal spray contains live, weakened influenza viruses, LAIV theoretically stimulates a stronger immune response than the shots, which contain killed viruses.
Influenza activity often begins to increase in October and peak sometime in late winter or early spring. The peak week of flu activity for the 2015-2016 season occurred on the last week of March 2016,

according to the CDC, which was one of the later season peaks on record. The CDC’s adjusted overall vaccine effectiveness (VE) against influenza A and B viruses for all ages was 47 percent, while the overall VE against A(H1N1)pdm09 was 41 percent and the overall VE against influenza B was 55 percent.

Vaccine manufacturers will provide an estimated 157 to 168 million doses of injectable influenza vaccine for the U.S. market. This is on par with last year’s vaccine distribution.

Source
https://www.cdc.gov/mmwr/volumes/65/rr/rr6505a1.htm?s_cid=rr6505a1_w

http://pediatrics.aappublications.org/content/early/2016/01/04/peds.2015-3279?sso=1&sso_redirect_count=1&nfstatus=401&nftoken=00000000-0000-0000-0000000000000000&nfstatusdescription=ERROR%3a+No+local+token

https://emergency.cdc.gov/han/han00387.asp

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5213a1.htm

http://www.cdc.gov/flu/about/season/flu-season-2015-2016.htm

https://www.cdc.gov/flu/professionals/vaccination/vaccinesupply.htm

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Diabetes Trends: National and by State

Frank Magliochetti Report – Diabetes Trends

The rates of diabetes across the United States have nearly doubled within the past 20 years, skyrocketing from 5.5 percent in 1994 to 9.3 percent in 2014. While diabetes prevalence is increasing, there is some good news on the horizon in regards to complication rates and access to preventive care.
Of the 12 states with the highest rates of diabetes, 10 are in the south, according to the CDC’s Diabetes Report Card. At 14.7 percent, Mississippi has the highest rate of diabetes. Colorado and Utah have the lowest rates of this metabolic disorder, with diabetes affecting only 7 percent of Utah residents and 6.8 percent of those living in Colorado. frankmagliochetti_diabetestrends-reportDiabetes rates vary between 8.1 and 10.4 in the Northeast. New Hampshire has the lowest rates in the region while Pennsylvania has the highest prevalence in the Northeast.
While the prevalence of diabetes is increasing, there has been a downturn in the percentage of diabetes complications over the past two decades. Deaths from hyperglycemic crisis have declined, for example, as have lower-limb amputations and end-stage renal disease. These declines may be, at least in part, the result of improvements in the rates of hypertension, high cholesterol, and smoking. Advancements in blood glucose control, early detection and management of complications, and strides in preventive care, treatment and management of diabetes.

Preventive Care Usage Trends: Across the Nation and by State

Preventive care varies considerably between states.

The percentage of adults with diabetes who report receiving preventive care practices across the nation is as follows:
• Annual foot exam: 67.5 percentfrankmagliochettireport-diabetes
• Annual eye exam: 62.8 percent
• Checked A1c two or more times a year: 68.5 percent
• Daily self-monitoring of blood glucose: 63.6 percent
• Ever attended a diabetes self-management class: 57.4 percent
• Flu vaccine: 50.1 percent
Preventive care usage varies by state. At 85.8 percent, adults with diabetes in Maine report receiving the highest number of annual foot exams as compared with all other states, while residents of Nevada received the fewest. Adults with diabetes in New Hampshire and Vermont also received more annual food exams than the national average.
Adults with diabetes in Iowa received more eye exams than those in other states at 76.5 percent, while those in Oklahoma received the least number of eye exams. Vermont diabetics were more likely to check their A1c levels more than twice a year, affordablecareact_frankmagliochettireportwhile those in Nevada were the least to receive such preventative care. Diabetes patients in Colorado had the highest percentage of attendance rates in diabetes self-management classes, while those in New York had the lowest. People with diabetes in Minnesota had the highest flu vaccination rates, and those in Florida had the lowest.
The upturn is due, at least partially, to the Affordable Care Act because it supports diabetes prevention and control by expanding insurance coverage, access to care, and consumer protections. As the result, Medicare and other insurance providers now cover an increasing number screening tests for diabetes, pre-diabetes, and for complications associated with diabetes. Providers also offer an expanding list of preventive benefits that help support beneficiaries in self-care and in making lifestyle changes that prevent or minimize development of comorbidities and complications associated with diabetes. The expansion of coverage and preventive care will continue to affect diabetes trends across the nation and within each state.

Source:
http://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Medication Adherence in the United States  

United States:  Medication Adherence Check Up

Non-adherence includes stopping, not starting, or taking less than the prescribed amount of a medication. More than half of all adults in the United States with a chronic illness report at least one episode of non-adherence to their prescription medication, according to the first National Report Card on Adherence. This report card, developed bymedical-adherance_frankmagliochettireport the National Community Pharmacists Association (NCPA), gives Americans a weak score when it comes to takingmedications as prescribed.

The Centers for Disease Control and Prevention (CDC) says that 80 percent of all medical treatments involve medication. The CDC also estimates that 20 to 30 percent of prescriptions go unfilled.

There is some good news in medication adherence trends, however. A study published in September 2016 shows that low adherence for anti-hypertensive medications decreased among Medicare beneficiaries from 37.4 percent in 2007 to 31.7 percent in 2012.

medication-adherance-appsTechnology is helping to improve adherence rates. Smartphone apps and other technologies have created a new medication adherence market, which offers computerized solutions that remind patients to take medications and take other measures to improve adherence. The global medication adherence market is growing at a significant rate, according to a P&S Market Researchpress release, boasting a 17.5 percent CAGR during 2016-2022.

 

Reasons for Poor Adherence

There are many reasons patients do not take prescriptions as directed. Forgetfulness, concerns about side effects, poor understanding of the need to take medications, affordability, and difficulty getting to the pharmacy are common reasons for poor adherence.

Pharmacy connectedness, which is a feeling of familiarity with a pharmacy provider, is an important factor when it comes to medication adherence. Only 36 percent of those who get their prescriptions by mail report pharmacy connectedness in the report card, while 67 percent of those who visit a chain pharmacy and 89 of those who go to a neighborhood pharmacy report a personal connection with their pharmacists. Patients living in the Northeast and Midwest are slightly more likely to report pharmacy connectedness; those living in urban areas are less likely to

Affordability is another primary predictor in whether a patient will take a medication as prescribed. Whether or not insurance pays for the drug, overall health and income often factor into the affordability of a medication.

Improving Medication Adherence

Healthcare providers can help patients improve medication adherence. Pharmacists are at the front line of addressing non-adherence. Establishing pharmacy connectedness with new patients and improving person connections with existing customers can help these healthcare professionals engage with clients, provide better information about the importance of taking medications as prescribed, and encourage them to better comply with medication regimens. Because of their greater personal connection with patients, independent pharmacists may be in particularly good position to optimize adherence.

Practitioners also play a vital role in stressing medication compliance, monitoring adherence, and helping patients manage side effects and other complicating factors that might prevent patients from taking medication as prescribed. Keeping patients well informed about health conditions can also improve compliance. Both prescribers and pharmacists can help reduce non-adherence by helping economically vulnerable patients find the most affordable medications.

Information, communication, and patient support help patients become engaged and involved in their own health care; they also improve patient satisfaction and loyalty. The results of the scorecard survey suggest patient engagement can reduce the currently high levels of prescription medication in the United States, and address the associated costs and health risks of non-adherence.

Source

http://www.ncpa.co/adherence/AdherenceReportCard_Full.pdf

https://www.cdc.gov/cdcgrandrounds/pdf/gr-pharmacists-10-21-2014.pdf

https://www.ncbi.nlm.nih.gov/pubmed/27432867

http://www.prnewswire.com/news-releases/global-medication-adherence-market-expected-to-grow-with-175-cagr-during-2016-2022-ps-market-research-574469501.html

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Nobel Peace Prize Winner for Medicine – Yoshinori Ohsumi

Dr. Yochinori Ohsumi Wins Nobel Peace Prize for Medicine 

Frank Magliochetti Report

Yoshinori Ohsumi is the sole winner of the 2016 Nobel Prize in Physiology or Medicine. Dr. Ohsumi is a cell biologist who specializes in autophagy, which is the process cells use to destroy and recycle cellular components the cells no longer use. Ohsumi has worked tireless for decades to elucidate the processes behind autophagy. Because of Ohsumi’s work in the 1990s, scientists can now explore the importance of autophagy in frankmagliochettireport_yoshinori-ohsumia number of physiological processes, such as the body’s response to infection or adaptation to starvation.

Scientists of the 1950s observed a special cellular compartment, known as an organelle, which contained enzymes that digest carbohydrates, proteins, and fats. One type of specialized compartment, or lysosome, works somewhat like a furnace to break down unwanted cellular debris.

Researchers of the 1960s found large amounts of cellular content inside lysosomes, which suggests cells have a strategy for transporting large cargo to the lysosome. Further investigation revealed a new type of structure transporting cellular cargo to the lysosome. molecular level. Nobel laureate Christian de Duve coined the term autophagy, which means “self-eating,” in 1963 to describe this transport process.nobel-prize-medal-frank-magliochetti-report

In the 1970s and 1980s, researchers worked to understand another cellular system used to degrade proteins. This other system, known as the Proteasome, degrades proteins one at a time. The mechanism did not explain how the cell disposes of larger protein complexes.

In a series of experiments in the early 1990s, Dr. Ohsumi used baker’s yeast to identify the genes responsible for autophagy. Mutations in these genes can cause disease and the very process of autophagy contributes to the development of several medical conditions, including cancer and disease of the nervous system.

The scientist then went on to shed light on the underlying mechanisms in autophagy in yeast then showed that a similar mechanism occurs in human cells. His discoveries led to a new of understanding how cells recycle their content.

A Groundbreaking Experiment

Yoshinori Ohsumi worked in a number of research areas, but decided to focus on protein degradation in an organelle that corresponds to the lysosome in human cells, known as the vacuole. Researchers like Dr. Ohsumi frequently use yeast cells in research because these cells are easy to study. Yeast cells are particularly useful for indentifying genes important in complex cellular pathways.

While yeast cells are easy to study, they do present a challenge in that the cells are small, which makes their inner structures difficult to distinguish with a microscope. Because of this, Ohsumi was uncertain whether yeast cells even participate in the autophagy process. He reasoned that, if he could disrupt the degradation process while the autophagy process was active, he would be able to see cellular content slated for degradation building up within the vacuole with his microscope.autophagy_frankmagliochettireport

Ohsumi cultured mutated yeast lacking the ability to degrade cellular waste while stimulating autophagy by starving the cells. Within hours, the vacuole filled with cellular content that had not degraded. This experiment proved that autophagy exists in cells. More importantly, the discovery gave Ohsumi a way to identify and characterize key genes involved in the autophagy process. Dr. Ohsumi published his results in 1992.

Next, Dr. Ohsumi exposed yeast cells to a chemical that randomly caused mutations in genes then induced autophagy. This allowed Ohsumi to identify the genes necessary for autophagy. In subsequent studies, he was able to characterize and research the proteins encoded by these genes. Dr. Ohsumi was able to show that a cascade of proteins and protein complexes controlled the autophagy process.

Thanks to the work of Dr. Ohsumi and other scientists, we now understand how autophagy controls important physiological functions that involve the degradation and recycling of cellular components.

Source:

https://www.ncbi.nlm.nih.gov/pubmed/1400575

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Combating Antibiotic Resistant Bacteria:

How the Fight is Progressing in 2016  

Frank Magliochetti Report

Bacteria that are resistant to common antibiotics have been around for some time. Unfortunately, they have frankmagliochetti_antibodiesbecome more widespread and more deadly than they were in times past. Following are some new major developments that may result in mankind either succumbing to antibiotic resistant bacteria or overcoming it altogether.

 

A New Danger

The civil war in Syria has nearly completely destroyed vital medical infrastructure. Thousands of doctors, nurses, medics, paramedics and other medical professionals have either been killed or have fled the country. Medical equipment is in short supply and operations are commonly conducted in caves or poorly lit basements. However, the war has brought about so many cases of antibiotic resistant bacteria that Newsweek has openly questioned whether or not the war may in fact spell the end of antibiotics altogether.

The root cause for this high level of antibiotic resistant bacteria are common the world over. Syrians, like many people around the world, used antibiotics far too freely in the past. However, the ongoing war has resulted in serious bacterial infections not seen outside of war zones. What is more, as Syrians travel in search of safety and shelter, the infections could potentially spread to others. Jordan, aware of the serious dangers that these infections may pose, has wisely implemented tight new controls on the use of Colistin to ensure that it is seldom used and thus remains effective against bacterial infections.

Another altogether different danger comes from the fact that a growing number of diseases are now becomingfrankmagliochettireport_worldhealthorganization more resistant to antibiotics than ever before. As the World Health Organization recently reported, cases of antibiotic resistant chlamydia, gonorrhea and syphilis are on the rise around the world. This has led the WHO to issue new guidelines specifying which antibiotics should and should not be used to combat these diseases. Serious fungal infections are also becoming resistant to antibiotics, a new trend that could have serious consequences for people with compromised immune systems.

New Answers

Thankfully, there are new answers on the horizon. German researchers at the University of Tubingen have recently been examining the human body to look for ways to combat infection. After analyzing bacteria found in the nose, they discovered a single gene that had the potential to help them create a completely new antibiotic. This antibiotic, currently known as lugdunin, has been tested on mice and the results show that it could effectively be used to treat both MRSA and Enterococcus infections.

Scientists at the University of Melbourne have taken a different route albeit one that is no less effective. Their new genetically engineered peptide polymers (or SNAPPs as they are more commonly known) can tear down cell walls and kill bacteria rather than simply halt the growth of infection. The SNAPPs are not toxic and pose no risk to infected people but further research is needed to determine how well the treatment works and what worldeconomicforum_frankmagliochettidangers it could pose.

It is also encouraging to see that world leaders are taking the threat seriously. On September 21, the United Nations General Assembly will host an all day, high level meeting on the topic of drug-resistant bacteria. Earlier this year, the World Economic Forum called for more research into antibiotic resistant infections while the G7 noted that tackling such infections should be a priority. The G20 recently made a united commitment to working together to reduce such infections. While only time will tell if these and other efforts will be successful, there is hope that one day antibiotic resistant bacteria will no longer result in serious infections, amputations and deaths.

Source

http://www.newsweek.com/2016/09/23/bashar-al-assads-war-syria-could-spell-end-antibiotics-498035.html

http://www.who.int/mediacentre/news/releases/2016/antibiotics-sexual-infections/en/

http://www.smithsonianmag.com/smart-news/fungal-infections-are-getting-worse-they-become-drug-resistant-180960283/?no-ist

www.bbc.com/news/health-36910766

http://news.nationalgeographic.com/2016/09/in-first–united-nations-will-consider-antibiotic-resistance/

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Mechanical Thrombectomy

Re-Emerging Technique for Removing Blood Clots

Frank Magliochetti Report

A brain stroke occurs when certain lymph, veins or arteries form a blood clot in the brain, which if not treated on time can cause brain damage, long term disability or death. CDC says that stroke is considered as one of the top five diseases and the cause of the most deaths in America. The intensity of the stroke depends on the age but Ischemic stroke usually occurs in adults. Every year, over 795,000 Americans have strokes resulting in around 130,000 deaths.   Since 2012, the standard procedure for treating a stroke has been tPA. There were trials conducted in the same year to create a more productive technique that would allow doctors to remove the blood clot completely. The FDA finally approved frankmagliochetti-report-_stent_retrieverthe “Neurovascular Stent Retriever” technique in late 2012. However, the technique did not come into fame until the year 2016. Now, this technique is used by many hospitals in the US to treat Ischemic strokes.

The technique is a mix of the stent retriever and tPA. To better understand the retriever process, one needs to understand how exactly tPA helped with removing the blood clot.

tPA, also known as Tissue Plasminogen Activator is a protein which is administered to the brain where the blood clot is. The protein converts the Plasminogen to plasmin, which breaks down the clot. This process proved successful in only one third of the patients. In the failed cases, the blood clot did reduce but did not disappear.

In order to take this process a step further, the FDA approved the neurovascular stent retriever process which removes the blood clot directly from the site.

tPA , neurovascular stent retriever process to remove blood clots has and will continue to save many lives. This re-emergence and enhancement to existing solutions can be considered a wake up call to how  existing technology can be revitalized with new breakthroughs to deliver an even more powerful solution.

-Frank Magliochetti 

First, tPA is registered so that the clot reduces in size and detaches itself from the blood vessels. Next, a stent retriever goes into the brain to remove the blood clot. The stent retriever is either made of metal or polymer and the usage of it depends on the patient’s age and the blood clot size. This neurovascular stent retriever procedure is called “Thrombectomy”

In 2012 this procedure had been used on various patients who had speedy recoveries, experts are trying to make a more flexible and thin catheter which can easily go through the femoral artery to extract the clot.

massachusettsgeneralhospital_frankmagliochetti

Massachusetts General Hospital in Boston is a 205 years old hospital that has two departments for treating strokes. The hospital has a neurology and neurosurgeon department that deals with patients with brain diseases.

According to WHO (World Health Organization), there are around 15 million people in the world who are the victims of strokes and diabetes.

WHO has encouraged all the underdeveloped countries to adopt this neurovascular stent retriever procedure. As compared to other medical innovations of 2016, this procedure has a low cost. FDA believes that by the end of 2016, Mechanical Thrombectomy will cure around 60,000 patients who will live a healthy life.who_frankmagliochettireport

 

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FDA approves Concentric Medical’s Trevo clot retrievers

http://www.massdevice.com/fda-approves-concentric-medicals-trevo-clot-retrievers/

September2, 2016

The FDA granted expanded approval to 2 of Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities.

The indications expand previous clearances for the devices, won in 2012, which cleared the stryker-frankmagliochettiretrievers for removing blood clots and restoring blood flow in stroke patients who can’t be treated with tissue plasminogen activator or for patients who didn’t respond to t-PA therapy.

“This is the first time FDA has allowed the use of these devices alongside t-PA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of t-PA alone. Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability,” FDA Center for Devices and Radiological Health neurological and physical  medicine devices division director Carlos Peña said in a press release.

“This new and unique indication for Trevo, as initial therapy for acute ischemic stroke with large vessel occlusions, has the potential to help hundreds of thousands of stroke patients,” Dr. Amrou Sarraj, of Houston’s University of Texas Health Science Center, said in prepared remarks. “These patients now have a significantly better chance for an independent life without disability.

“So many patients with major ischemic stroke due to large vessel occlusions still go untreated today, largely ending up with a devastating long term disability,” Sarraj said. “The FDA clearance of the Trevo retriever as a front-line treatment to reduce disability reinforces the importance that all caregivers in the stroke pathway – from EMS to emergency room physicians to neurologists to interventionalists – continue to come together to deliver fast and efficient treatment of stroke.”

Trevo is a transcatheter clot removal device designed to retrieve blood clots by gripping at the clot and pulling it back through the blood vessel along with the device, according to the FDA.

Approval came based on data from a clinical trial of the device along with t-PA and medical management of blood pressure and disability symptoms which found that 29% of patients treated with the Trevo device were functionally independent at 3 months, 10% higher than those not treated with the device.

Stryker picked up Concentric Medical in 2011 for $135 million.

 

Thrombectomy System Market: Overview

http://www.openpr.com/news/356824/Forecast-On-Thrombectomy-System-Market-Global-Industry-Analysis-and-Trends-till-2025.html
With rapid technological advancement, increase in the number of aging population and increase in demand for minimally invasive surgery, the thrombectomy system global market is expected to have healthy growth rate in the forecast period (2012-2025).

Thrombectomy System Market:
Depending on geographic region, global thrombectomy system market is segmented into seven key regions: North America, South America, Eastern Europe, Western Europe, Asia Pacific, Japan, and Middle East & Africa.
North America holds the largest share of the global thrombectomy system market, due to high aging population and wide technological advancement.

Wall St. darling Penumbra launches latest thrombectomy device in the U.S.

http://www.fiercebiotech.com/medical-devices/wall-st-darling-penumbra-launches-latest-thrombectomy-device-u-s

Penumbra ($PEN), one of the top devicemaker IPOs last year, unveiled its latest thrombectomy product to the U.S. market.

Dubbed the ACE 68 Reperfusion Catheter, the vascular device uses the latest tracking technology to extract blood clots in acute ischemic stroke patients more quickly and safely, the company said. The device, which is part of the company’s Penumbra System, was penumbra-frankmagliochettireportdesigned with a new tracking platform from hub to tip, and features a unique coil winding geometry along 16 transitions to deliver an optimal tracking profile.

The announcement, along with supporting data, was made Monday at the Society of NeuroInterventional Surgery’s 13th Annual Meeting in Boston.

The Alameda, CA-based company markets medical devices that include several neurovascular access products, the ACE system, neurovascular embolization products, a neurosurgical tool as well as peripheral embolization and thrombectomy devices.

Penumbra, which raised about $125 million when it went public last September, has seen its stock price trade in a 52-week range of $35.31 to $61.87. Canaccord Genuity, which recently set a price target of $67 per share for Penumbra, has raised its rating of the company to a buy. Canaccord pegged Penumbra’s market cap at $1.83 billion with a price-to-earnings ratio of 959.19.

In May, Penumbra reported total revenue grew to $57.9 million in Q1 versus $39 million for the same period a year ago. Analysts had set a consensus estimate of $53.1 million. Revenue for neuro products grew to $41.3 million for the period, and sales of peripheral vascular products increased to $16.6 million.

Trevo Clot Retrievers Approved for Use

Direct Thrombectomy Safe, Effective in Stroke Patients

FDA Approves Trevo Device for Stroke

http://www.medscape.com/viewarticle/868389

Two devices for mechanically removing blood clots now can be used in conjunction with clot-dissolving tissue plasminogen activator (tPA) as an initial therapy for acute ischemic strokes, the US Food and Drug Administration (FDA) announced today.

The devices in question are the Trevo ProVue and Trevo XP ProVue Retrievers, both from Concentric fda-frank-magliochetti-reportMedical. The FDA first approved this clot-removal technology in 2012 to restore blood flow in patients experiencing strokes who can’t receive tissue plasminogen activator (tPA) and patients who don’t respond to the drug.

In broadening the indication, the agency said that the Trevo clot retrievers should be used within 6 hours of symptom onset and only after tPA is administered.

“This is the first time FDA has allowed the use of these devices alongside tPA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of tPA alone,” said Carlos Peña, PhD, director of the Division of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health, in a news release. “Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability.”

The Trevo clot retrievers are inserted into the occluded blood vessel via catheter. An expandable wire mesh at the distal end grips the clot, which a physician can pull back through the blood vessel along with the device for extraction through a catheter or sheath.

The FDA approved the expanded indication for the Trevo clot retrieval technology on the basis of a clinical trial comparing 96 randomly selected patients treated with the device as well as tPA and medical management of blood pressure and disability symptoms; 249 patients received only tPA and medical management. Of patients undergoing thrombectomy with a Trevo device, 29% were functionally independent 3 months after their stroke. This was the case for only 19% of those forgoing thrombectomy.

The Trevo devices come with the risk of failure to retrieve the clot, malfunctions such as breakage, and navigation problems that can lead to perforated blood vessels.

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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