Product Review: TriClip Transcatheter Tricuspid Valve Repair System

Cardiovascular diseases are one of the leading causes of death worldwide, but most of them could be prevented with proper medical interventions. However, the introduction of smart applications, remote monitoring, and minimally invasive approaches have been successful in targeting the gaps in vascular health care through technology and saving millions of lives. Many new treatment options are being developed to eliminate the need of open-heart surgery as it carries a high degree of risk. The advent of transcatheter tricuspid valve intervention (TTVI) devices as an alternative treatment option for tricuspid regurgitation (TR) or the leaky tricuspid valve have revolutionized the field of structural cardiology. Designed to reduce TR severity by valve leaflet plication, the percutaneous coronary devices have gained a lot of recognition due to their ability to treat severe TR in a minimally invasive way without posing the risk of severe complications. Currently, 80% of mitral regurgitation treatments are being performed with the MitraClip/TriClip™ system worldwide to address the specific features of the transcupid valve anatomy.

Abbott’s TriClip™ is the first-of-its-kind transcatheter tricuspid valve repair clip device to receive CE mark clearance as a non-surgical treatment option for people with TR. The minimally invasive clip-based device is an iteration of the company’s highly popular and successful MitraClip used for transcatheter mitral valve. The next-generation clip-based therapy, also known as TriClip™ G4 consists of a leaflet grasping feature and new clip sizes to accommodate and tailor repair of the unique anatomy of each patient. Leaving TR unaddressed for a long period can lead to atrial fibrillation, heart failure, or even death so Abbott’s TriClip™ serves as a suitable option for patients with multiple co-morbidities. Thus, the device prevents the high-risk patients undergo the open-heart surgery, which could present a number of complications. The new-generation clip therapy can enhance the cardiologists’ ability to repair tricuspid valves safely and effectively, thus dramatically improves the quality of life for people with severe and symptomatic tricuspid regurgitation. Post-implantation of the clip device, the patients can significantly eliminate symptoms such as shortness of breath, fatigue, decline in endurance, ascites, and peripheral edema.

The six-month pivotal TRILUMINATE CE Mark study examining edge-to-edge repair technique using Abbott’s new clip therapy demonstrated a significant reduction in the severity of debilitating TR, sustained symptomatic improvements and enhanced functional status of the heart. Therefore, the physicians consider the device to be highly safe, durable, and reliable for the treatment of TR in high-risk patients or people with moderate or severe TR. The TriClip™ device has the potential to repair the tricuspid valve without open-heart surgery only by clipping together a portion of leaflets to reduce the blood flow. The minimally invasive approach allows the heart to pump blood more efficiently and relieve symptoms associated with the tricuspid valve leakage.

Although Abbott’s TriClip™ device is built upon the same technology of the company’s MitraClip transcatheter mitral valve therapy that is employed to treat leaky mitral valves, the next-gen device differs in terms of the delivery system. The new, steerable guiding catheter system is engineered to adapt the right side of the heart where the transcupid valve is present. To meet the needs of unique anatomies of patients, Abbott’s TriClip™ is available in two different sizes (NT & XT). Currently, the TriClip™ is approved for use in Europe and other countries that recognize the CE mark.

The TriClip™ system consists of mainly two parts, steerable guide catheter (SGC) and clip delivery system (CDS). The CDS includes a steerable sleeve, delivery catheter, and wide chrome cobalt clip of 4 mm (NT size) and 7 mm (XT size) with articulated arms. The SGC in the new TriClip™ design contains two knobs for steering maneuvers. Besides, the steerable sleeve includes only one knob intended for deflecting the tip and reducing the radius of the distal curve. The modifications facilitate the bending and guiding of maneuvers into the right atrium. The device is used to clip the two leaflets together at the center and create two smaller openings to form a tighter seal. The upgraded TriClip™ allows clinicians to customize the procedure to each patient’s unique valve and independently grasp leaflets before fastening. With 100% implant success rate, the device can help to save time and costs of patients by reducing the need for hospitalization by 40%.

Other Alternative for Minimally Invasive Tricuspid Therapy

Edward LifeSciences-PASCAL
The PASCAL device can be successfully adapted to reduce TR as it creates a new surface for coaptation of tricuspid leaflets, which helps in reducing leakage. The medical device consists of a foam-filled spacer that is inserted through axillary vein into the regurgitant orifice. PASCAL has a length of 42 mm and diameter of 12 and 15 mm and advocated for use in moderate-to-severe TR. Its 22F delivery system enable easy manoeuvring in three planes and stabilizers lock handles for convenient procedure. The major benefit of central spacer is that the surgeon does not need to pull the leaflets of valve as one would do during a conventional procedure. Thus, the implantation of the device helps to repair the valve by better distributing the forces of the system throughout valve leaflets and thus help in efficient working of the heart.

The PASCAL repair system offers a minimally invasive approach for patients as the device is inserted through the groin area making an entry point of 0.7-0.8 cm. The independent clasping function of the PASCAL repair system provides some benefits to the physicians. During the surgery, the surgeon can individually control each side of the clasp machine, which could not be performed earlier. The technique allows the physicians to reopen one side of the clasp while keeping the other clasp in the stationary position, which helps to optimize its capture and reclose the system. The independent leaf capture method enhances the efficacy of the PASCAL system and provides optimal results. The patient can be easily extubated post-procedure and sent to normal ward. Unlike with valve surgery, the patient does not require pain medications and can be discharged within two days. After a week, the patient can even return to their daily activities and live a normal life.

The relatively new tricuspid therapy by Edward Lifesciences, known as FORMA, has been designed specifically for the treatment of leakage in tricuspid leaflets, but the medical device is currently under clinical trials and has yet to receive CE approval.

Conclusion
TriClip™ Transcatheter Tricuspid Valve Repair System is a promising technique that offers feasibility, safety, and excellent outcomes. In the coming years, the clip-based therapy is set to bring forward a paradigm shift in the management of tricuspid regurgitation (TR). However, the medical device needs to analyzed in more clinical trials to determine its efficacy against the tricuspid therapies. Also, the use of transcatheter tricuspid valve does not provide satisfactory results for patients with previous valve surgery, PPML, and moderate to severe organic or aortic valve diseases. So, new methods and techniques need to be devised to expand the scope of the treatment modalities for more patients with cardiovascular problems.

According to TechSci research report on “Global Interventional Cardiology Devices Market By Product Type (Angioplasty Balloons, Angioplasty Stents, Structural Heart Devices, Catheters, Plaque Modification Devices, Hemodynamic Flow Alteration Devices, Others) By End User (Hospitals & Clinics, Ambulatory Surgery Centers, Others) By Region, Competition Forecast & Opportunities, 2026″, the global interventional cardiology devices market is anticipated to grow at a significant CAGR during the forecast period. The growth can be attributed to advancements in medical devices and rapid surge in the demand for minimally invasive surgeries. Additionally, high demand for novel products for the treatment of cardiovascular diseases to reduce risks and rising incidences of heart problems are contributing to the growth of global interventional cardiology devices market.

According to another TechSci research report on “United States Heart Valve Devices Market By Type (Mechanical Heart Valves, Biological Heart Valves, Transcatheter Heart Valves), By Product Type (Replacement (Aortic, Mitral, Others), Repair), By Valve Type (Tissue Valve, Mechanical Valve), By Procedure (Surgical, Transcatheter), By Application (Aortic Stenosis, Aortic Regurgitation, Mitral Stenosis, Mitral Regurgitation, Pulmonary Valvular Heart Disease), By Region, Forecast & Opportunities, 2025″, United States heart valve devices market is expected to witness significant growth during the forecast period. The growth can be attributed to the increasing geriatric population and rising prevalence of cardiovascular diseases. Moreover, rapid advancements in healthcare infrastructure and easy access to healthcare services are boosting the growth of United States Heart Valve Devices market. In addition, rise in sedentary lifestyle and growing obese population are increasing the number of patients with heart problems, which is contributing to the growth of United States heart valve devices market.

COVID Vaccine Dystopia: A Manifesto

Introduction
We are at the edge of history, in a global society where there is great suffering and injustice because of the widespread commitment to get the entire population jabbed with COVID vaccines that the government claims are safe. As shown below, in truth there is ever increasing deaths and harmful health impacts from all the COVID vaccines. But governments do not give credence to the many awful health impacts of the vaccines, no matter how many esteemed physicians and medical researchers present evidence for stopping vaccination efforts.
The political and medical establishments keep using the same insensitive argument. No matter how many people die from the vaccines – often within days of getting jabbed – those in power proclaim that more lives are saved from using the vaccines against COVID than are lost due to them. So many thousands of people worldwide have died from the jabs, probably 100,000 or more based on data from CDC, the European Union and other nations. But negative vaccine impacts are largely ignored by big media, the public health system and authoritarian politicians. Sneaking into the public limelight are some famous people dying from the shots from the realms of sports, entertainment and politics. But these are easily forgotten or ignored. Or seen as exceptions, statistically speaking.

New analysis of all major vaccines
Physician J. Bart Classen published an extremely valuable analysis. He examined clinical trial data from all three of the major vaccine makers and found their vaccines cause more harm than good. Here are highlights from his article.
Data were “reanalyzed using ‘all cause severe morbidity,’ a scientific measure of health, as the primary endpoint. ‘All cause severe morbidity’ in the treatment group and control group was calculated by adding all severe events reported in the clinical trials. Severe events included both severe infections with COVID-19 and all other severe adverse events in the treatment arm and control arm respectively. This analysis gives reduction in severe COVID-19 infections the same weight as adverse events of equivalent severity. Results prove that none of the vaccines provide a health benefit and all pivotal trials show a statically significant increase in ‘all cause severe morbidity’ in the vaccinated group compared to the placebo group.”
In other words, he found that each of the vaccines caused more severe events in the immunized group than in the control group. No safety.
This was his main conclusion: “Based on this data it is all but a certainty that mass COVID-19 immunization is hurting the health of the population in general. Scientific principles dictate that the mass immunization with COVID-19 vaccines must be halted immediately because we face a looming vaccine induced public health catastrophe.”

Manipulation of data
The trick used by CDC that was revealed in some publications, but not big media, is to count the deaths of fully vaccinated people as unvaccinated if the deaths occurred within 14 days of their final vaccination.
Their goal was to make unvaccinated people look like pandemic culprits causing the continued spread of COVID. Indeed, what big media did produce to influence public opinion was that unvaccinated people were the problem. All this to help convince more people to get vaccinated.
In truth, the medical reality is that vaccinated people are dying for two reasons. Some are inflicted with serious health impacts from the vaccines themselves, such as blood clots that kill people from strokes and other maladies. Second, many are victims of breakthrough COVID infections that can cause death because vaccines over time become increasingly ineffective in protecting against COVID.
To add more context to what CDC has done, consider the following report of a revelation by a whistleblower.
In sworn testimony she claiming to have proof that 45,000 Americans have died within three days of receiving their COVID-19 shot. The declaration is part of a lawsuit America’s Frontline Doctors (AFD) against U.S. Department of Health and Human Services Secretary Xavier Becerra. That is a remarkably higher number than CDC has reported.
According to the whistleblower’s sworn document, she is “a computer programmer with subject matter expertise in the healthcare data analytics field, an honor that allows me access to Medicare and Medicaid data maintained by the Centers for Medicare and Medicaid Services (CMS).”
After verifying data from the CDC’s adverse reaction tracking system VAERS, the whistleblower focused only on individuals who died within three days of receiving their shot.
“It is my professional estimate that VAERS (the Vaccine Adverse Event Reporting System) database, while extremely useful, is under-reported by a conservative factor of at least 5,” she added. She came to that conclusion by examining the Medicare and Medicaid data in respect to those who died within three days of vaccination
It should be noted that some years ago a Harvard study found that the system could be undercounting by a factor of 10 to 100.

EXAMPLE OF WHY 12 -DAY CDC PRACTICE IS FRAUDULENT: Back in January there was a news story about the death of 56-year old Florida doctor Gregory Michael who died from a rare autoimmune disorder he developed on December 21 three days after receiving the Pfizer vaccine. His wife said that in her mind his death was 100% linked to the vaccine. One doctor came forward publicly to say he also believed the vaccine caused the victim to develop acute idiopathic thrombocytopenic purpura (ITP), the blood disorder and brain hemorrhage that killed him. Dr. Jerry L. Spivak, an expert on blood disorders at Johns Hopkins University, who was not involved in Dr. Michael’s care, said “I think it is a medical certainty that the vaccine was related. It happened and it could happen again.” His medical reasons were that the disorder came on quickly after the shot, and “was so severe that it made his platelet count ‘rocket’ down.” Over following months huge amounts of medical research documented vaccine induced blood problems, including the one that hit the Florida physician.
There is still more to the data corruption designed to send a deceitful message to the public. A July story noted: “a physician contacted the Globe and said testing protocol from Scripts [health care system] is indicating that they aren’t testing the vaccinated in the hospitals – they are only testing the unvaccinated for COVID despite the many COVID breakthrough cases reported. The physician contacted another hospital and reported to the Globe: ‘They HAVE NOT been testing the vaccinated for COVID routinely like they have the unvaccinated, but they JUST changed their policy to begin doing this.’ Unbelievable! So all this BS in the newspapers has been spewing about the vaccinated NOT having COVID BECAUSE THEY DON’T TEST FOR IT!” All this was done very likely in hospitals all over the nation so that big media could push the story that there was a “pandemic of the unvaccinated.”
There is still more corruption to acknowledge.
In 2020 CDC issued new instructions for medical examiners, coroners and physicians to give more credit for COVID as the cause of death. Pre-existing conditions or comorbidities were to be recorded in Part II rather than Part I of death certificates. This was a major rule change from the 2003 handbooks to be used for reporting deaths. This single change resulted in a significant inflation of COVID-19 fatalities by instructing that COVID-19 be listed in Part I of death certificates as a definitive cause of death regardless of confirmatory evidence, rather than listed in Part II as a contributor to death in the presence of pre-existing conditions, as would have been done using the 2003 guidelines. The result was significant inflation in COVID fatality totals by as much as 1600% above what they would be had the CDC used the 2003 handbooks. It comes down to what many people now understand, namely so many people die with COVID but not FROM COVID.
As a final example of data corruption and shortcomings, consider what was revealed at a recent meeting of nurses. They explained what they are facing in their hospital work, which also helps explain why so many nurses and physicians have refused vaccination. One nurse said she ran an ER department, and that it was tragic that they were seeing so many heart attacks and strokes, and that it is obvious that they are related to the COVID-19 shots. Another nurse stated that she was never trained about how to submit a report to VAERS about vaccine adverse events, and did not even know it existed until she did some research on her own. She said there is pressure to NOT report vaccine injuries and deaths, and it takes about 30 minutes to fill out the report, which few will do.

British and other International data show vaccine truths
A new report with detailed data from Public Health England provides some startling numbers. For the period of February 1 through August 2 there were COVID Delta variant cases for 47,000 people who had received 2 vaccine doses, and for 151,054 people who were unvaccinated.
In the first group of vaccinated people there were a total of 402 deaths. In the second much larger group with more than three times unvaccinated people there were just 253 deaths. In other words, of the total COVID deaths 61 percent were in fully vaccinated people.
To get the death rate you divide the number of deaths by the total number of infection cases. That gives a death rate of.86 percent among the vaccinated and.17 percent among the unvaccinated.
That is an amazing difference. The death rate among vaccinated was just over five times greater than that for the unvaccinated.
Five times greater! In other words, unvaccinated people who got infected were enormously safer from death. Proving that COVID vaccines are not safe.
How can we explain this huge difference in terms of medical science?
It should also be noted that it was determined that the measured viral load in both groups was the same. So, why are vaccinated people dying more frequently than the unvaccinated. Here are some plausible explanations.
First, there is something very dangerous and unsafe in the COVID vaccines associated with spike proteins that are causing people to die at a higher rate. For example, as discussed elsewhere, all current vaccines have been associated with serious blood problems, notably both large and microscopic blood clots. Many people have died from brain bleeds and strokes, for example. There are also many, many other types of adverse side effects causing a host of medical problems.
Second, it is reasonable to believe that most unvaccinated people have acquired natural immunity from some prior COVID infection. And that natural immunity is far more protective than the artificial or vaccine immunity obtained from jabs. Their natural immunity translates to fewer deaths. Yet the US like many other countries does not give credit for natural immunity on a par with vaccine immunity when it comes to COVID passports and mandates. Though a few nations do the right thing by honestly following the science.
Third, vaccinated people are susceptible to breakthrough infections, which means that they are not protected against infection after they have been originally infected. Phony and dangerous COVID vaccines do not destroy the virus, nor prevent transmitting it to others. Some breakthrough infections are lethal.
Putting aside problems with CDC data, the death rate found in the UK for vaccinated people translates to about 1,300 deaths for vaccinated Americans. Indeed, an August report revealed that new CDC data indicated 1,507 people of those fully vaccinated died. It seems like these figures are only for breakthrough infection deaths, because the CDC VAERS database indicates more than 6,000 vaccine deaths (through August 27) that are reported as vaccine adverse effects. [But nearly 14,000 deaths apparently when non-US data are included.]

Just days ago, it was reported that West Virginia saw a 25% increase in deaths of people that are fully vaccinated over the last eight weeks. At the same time it was reported that in Massachusetts 144 people fully vaccinated also died from COVID, an 80 percent increase from several weeks earlier, and that new total translates to about 4,800 for the whole nation. In New Jersey there was a 16 percent increase in breakthrough deaths recently.
The new data from England involving very large numbers of people should be headline news. But the biased and dishonest big media suppress this kind of critical data. Why? Clearly, if vaccinated people die at a much higher rate than unvaccinated people, then why should people be enthusiastic about being vaccinated for initial shots or later booster ones? They should not. This is especially true for the millions of people who have natural immunity.
Data from other countries merits attention because of still more proof of the deficiencies of the COVID vaccines.
In August director of Israel’s Public Health Services, Dr. Sharon Alroy-Preis, announced half of all COVID-19 infections were among the fully vaccinated. Signs of more serious disease among fully vaccinated are also emerging, she said, particularly in those over the age of 60.
A few days later, Dr. Kobi Haviv, director of the Herzog Hospital in Jerusalem, reported that 95% of severely ill COVID-19 patients are fully vaccinated, and that they make up 85% to 90% of COVID-related hospitalizations overall.
Add these results from research in Israel: People who were vaccinated in January and February were, in June, July, and the first half of August, six to 13 times more likely to get infected than unvaccinated people who were previously infected with the coronavirus; that is, people with natural immunity. In one analysis, comparing more than 32,000 people in the health system, the risk of developing symptomatic COVID-19 was 27 times higher among the vaccinated, and the risk of hospitalization eight times higher.
In Scotland, official data on hospitalizations and deaths show 87% of those who have died from COVID-19 in the third wave that began in early July were vaccinated.
In Ireland, 18 percent of COVID deaths were in fully vaccinated people.

Great article on vaccine failure
This recent article displays a lot of wisdom about COVID vaccines; here are some excerpts.
“The Corona vaccines don’t work very well. Ubiquitous statistics showing that the vaccinated enjoy substantial protection against serious illness and death seem wrong. In some cases they are probably manipulated. They are certainly confounded by the different testing regimes to which the vaccinated and the unvaccinated are subjected. Once you forget the specifics of efficacy and look at the broader picture, it is easy to see where we are. The vaccines have not reduced Corona mortality compared to the same time last year in any jurisdiction that I know of. Countries with high vaccination rates are now seeing the same number of deaths, or more, as they had at the beginning of September 2020.”
“The vaccinated remain substantially protected against serious illness or death, but the unvaccinated are entering the hospital and dying at very high rates indeed, as if to compensate. Thus Israel has maintained the same case fatality rate of around 0.7%, before and after mass vaccination.”
“Vaccines against coronaviruses have been used in animals for decades, and none of them work very well. Generally they begin to fail after a few months. Despite their technical sophistication, our mRNA and vector vaccines against SARS-2 are no different. They had some success when they were first rolled out, but if anything that probably made things worse.”
“Our universal vaccination campaigns worked just well enough to speed up the evolutionary processes that are always and everywhere optimising Corona.” That means the virus keeps outwitting us.
“It is impossible to believe that this failure was not foreseen. The scientists who developed the vaccines knew for sure how things would play out. That’s why they concluded the trials after three or four months and vaccinated their controls. It’s why they have been talking about boosters from the very beginning. It’s why, if you listened carefully, you never heard Zero Covid sloganeering coming from Team Vaccine. Only the comparative morons on Team Lockdown ever talked like that.”
“Our politicians and our new public health dictators, on the other hand, remained oblivious to the limited potential of the vaccines. They continue to insist on universal vaccination and green passes, while it is obvious that these will do nothing to influence the course of the pandemic.”
“Corona policy in every western country has unfolded more or less according to the same script, devised by the World Health Organisation at the end of February 2020. The final act was supposed to be the wide-scale eradication of Corona after mass vaccination. It is now clear that this will never happen. For the first time since March 2020, there is no obvious international consensus on the way forward.”
“A few countries, or perhaps even a few prominent politicians or public health pundits who do not have their heads up their asses, could change everything. Everyone who is not crazy needs to start insisting on the same simple message:
We have to live with Corona, it will always be with us. Biannual boosters for the entire population will not solve anything. They will only reduce the effectiveness of vaccines by encouraging antigenic drift. The vaccines are, at best, a solution for the elderly and the vulnerable only. Everyone will get Corona, even the vaccinated, and children need to get it while they are still young and while it poses no risk to them. In this way, SARS-2 will become an unimportant virus in the coming years.” But will that happen before we suffer through a vaccine dystopia?
This article gave no attention to treatments, but here is one of the many comments that addressed this issue well:
“When do the powers that be start focusing on TREATMENTS for those who contract covid, regardless of vaccination status?? No other infection, condition, desease, etc doesn’t have treatment options, except for covid… they, the powers that be, go so far as to block treatment options or make them incredibly hard to get. It’s past time to make the various treatments readily available… they don’t have to be 100% successful, but we should be given the choice to try them!!”
Vaccine dystopia seen by some esteemed scientists
If the material above has made you depressed, you may not want to keep reading. Some great medical scientists have gone public with very negative views of the future because of mass COVID vaccine use.
Chief among these forecasters of vaccine doom is Dr. Judy Mikovits. She became widely seen as a conscientious whistle blower when she talked about “mass murder” and said that 50 million Americans will die because of the vaccines. Her medical science credentials are impeccable, including a long stint at the National Cancer Institute. Her views may seem extreme to some people, but they are based in deep scientific understanding and are consistent with the highly frightening forecasts of other scientists and physicians.
Here are some of her views:
“Most people don’t realize the [COVID] vaccines do not prevent infection. You’re injecting the blueprint of the virus and letting a compromised system try to deal with it. And worse, it doesn’t go in the cells that a natural infection would, that have lock and key receptors, gatekeepers, so that only certain cells can be infected, like the upper respiratory tract for a coronavirus. Now you’re making it in a nanoparticle which means it can go in every cell without that receptor. So, can you imagine the damage of bypassing God’s natural immunity and allowing the blueprint for coronavirus that also has components of HIV in some strains, meaning you can infect your white blood cells. So now you’re going to inject an agent into every cell of the body. I just can’t even imagine a recipe for anything other than what I would consider mass murder on a scale where 50 million people will die in America from the vaccine. The numbers from the XMRV’s (xenotropic murine leukemia virus-related virus) and the vaccine injuries for the (past) 40 years support that.”
Her warning that these injections can cause death is confirmed by Dr. Sucharit Bhakdi, an award winning researcher and former head of the Institute of Medical Microbiology and Hygiene in Germany; he was a professor of virology and microbiology for 30 years in Germany. In the statement shown below, he warns that by taking these injections, killer lymphocytes already present in our body will cause an auto-immune attack with terrible consequences for our health and even death. He made this statement:
“The big, big danger about this vaccine is you are shooting the gene of the virus into your body. It is going to go through the body and go to entering cells that you don’t know. These cells are going to start making, not the whole virus, but virus protein, and these cells are going to put the waste of that spike protein in front of their cells. And the killer lymphocytes will see the waste, and, you know, anyone who does not understand there is going to be an autoimmune attack because the killer lymphocytes are already there. It is with this that I will say, “Bye bye,” (death) because you don’t realize what you are going to do. You are going to plant the seed of autoimmune reactions.”
Dr. Sherri Tenpenny is board certified in emergency medicine and osteopathic manipulative medicine and author of several books on the impact of vaccines. When she was specifically asked about the forecast from Dr. Mikovits, she said: “If they don’t die, they’re going to be seriously injured. There are some things in life that are worse than death, you know, having to live with chronic inflammatory drug induced hepatitis, you know, having chronic seizure disorders, having debilitating autoimmune diseases. Some people are so sick it would be merciful if they died.”
Add to these views the warnings from Dr. Michael Yeadon, former Vice President of Pfizer with a PhD in respiratory pharmacology, and Dr. Wolfgang Wodarg, former head of the Public Health Department in Germany and a doctor of pneumology. They sent an urgent petition to the European Union demanding a halt to COVID-19 vaccine studies due to safety concerns. They specifically identified the following serious side effects:
Infertility
Allergic, potentially fatal reactions due to polyethylene glycol (PEG) which is contained in the vaccine.
Exaggerated immune reactions, especially when the vaccine recipient is confronted (later in life) with the real “wild” virus. They report that these exaggerated immune reactions to corona vaccines have long been known from experiments with cats. 100% of the vaccinated cats died after catching the wild virus.
Here are a few more examples of dire predictions about the COVID vaccines:
Dr. Luc Montagnier, a French virologist and recipient of the 2008 Nobel Prize in Medicine for his discovery of the human immunodeficiency virus (HIV) is worth listening to. He has a doctorate in medicine and has received more than 20 major awards. Montagnier refers to the mass vaccine program as an “unacceptable mistake” and is a “scientific error as well as a medical error.” His assertion is that “The history books will show that… it is the vaccination that is creating the variants.” In other words: “There are antibodies, created by the vaccine,” forcing the virus to “find another solution” or die. This is where the variants are created. It is the variants that “are a production and result from the vaccination.” He is talking about the mutation and strengthening of the virus from a phenomenon known as Antibody Dependent Enhancement (ADE). ADE is a mechanism that increases the ability of a virus to enter cells and cause a worsening of the disease. His bottom line: “Faced with an unpredictable future, it is better to abstain.” But most people will find it extremely difficult to resist all the coercion and vaccine mandates. As to the much talked about and hope for herd immunity, he has said: “the vaccines Pfizer, Moderna, Astra Zeneca do not prevent the transmission of the virus person-to-person and the vaccinated are just as transmissive as the unvaccinated. Therefore, the hope of a ‘collective immunity’ by an increase in the number of vaccinated is totally futile.”

Dr. Vanden Bossche has considerable credentials that make his views worth consideration. He has PhD degree in Virology from the University of Hohenheim, Germany and has held faculty appointments at universities in Belgium and Germany. He was at the German Center for Infection Research in Cologne as Head of the Vaccine Development Office. He has said: “Given the huge amount of immune escape that will be provoked by mass vaccination campaigns and flanking containment measures, it is difficult to imagine how human interventions would not cause the COVID-19 pandemic to turn into an incredible disaster for global and individual health.” He talks about selective viral ‘immune escape’ where viruses continue to be shed from those who are infected [both vaccinated and nonvaccinated] because neutralizing antibodies fail to prevent replication and elimination of the virus. A frightening forecast by Bossche is that the worst of the pandemic is still to come. Hard to believe considering all the bad news propaganda about cases, hospitalizations and deaths. But he thinks we are now experiencing the calm before the ultimate storm. Imagine a new wave of infection far worse than anything we’ve seen so far is how Bossche thinks. How does this happen? There will be more mutants or variants to which the adaptive immune system from vaccine shots provides little resistance. At the same time there will be decreased innate or natural immune effectiveness. Unless people take a number of steps to boost their natural immunity. Here is his big picture view: “There is only one single thing at stake right now and that is the survival of our human race, frankly speaking.” This too is a very strong view. The “mass vaccination program is… unable to generate herd immunity.” If true, there is little hope of seeing the COVID pandemic ending.
In a public comment to the CDC on April 23, 2021, molecular biologist and toxicologist Dr. Janci Chunn Lindsay, Ph.D., called on CDC to immediately halt Covid vaccine production and distribution. Citing fertility, blood-clotting concerns (coagulopathy), and immune escape, Dr. Lindsay explained to the committee the scientific evidence showing that the coronavirus vaccines are not safe. She holds a doctorate in biochemistry and molecular biology from the University of Texas, and has over 30 years of scientific experience, primarily in toxicology and mechanistic biology. “I strongly feel that all the gene therapy vaccines must be halted immediately due to safety concerns on several fronts,” she said. Also noted was that “Covid vaccines could induce cross-reactive antibodies to syncytin [a protein], and impair fertility as well as pregnancy outcomes.” Yet another issue was this: “there is strong evidence for immune escape, and that inoculation under pandemic pressure with these leaky vaccines is driving the creation of more lethal mutants that are both newly infecting a younger age demographic, and causing more Covid-related deaths across the population than would have occurred without intervention. That is, there is evidence that the vaccines are making the pandemic worse.”
Dr. Theresa Deisher warned about the dangers of mRNA permanently re-writing our genetic code by making changes to our DNA. She graduated with honors and distinction from Stanford University, and obtained her Ph.D. in Molecular and Cellular Physiology from the Department of Molecular and Cellular Physiology, Stanford University. “The vaccines that are messenger RNA (mRNA), what they do is they act like a virus and they hijack the cell’s machinery to turn that mRNA into the protein. Now, messenger RNA can also be what’s called reverse transcribed into DNA. Okay, an RNA virus uses a reverse transcriptase in our cells to make itself into DNA and permanently insert into the genome. Viruses can do that. There is a possibility that the messenger RNA could be made into DNA and be permanently inserted. It doesn’t have all of the efficient components of a virus but the spontaneous possibility is there. In a gene therapy trial, the experts said the danger is 10 to the minus 13 (which is one in a trillion). Four of nine boys (participating in the trial) had DNA insertions and developed leukemia. Four of nine is a lot different from one in a trillion.”
Dr. Johan Denis, medical doctor and homeopath from Belgium, warns, “This vaccine is just not proven safe. It has been developed too quickly. We have no idea what the long term effects will be. It needs much more investigation. There is no hurry or emergency. It might possibly change your DNA. This is irreversible and irreparable for all future generations.”
Report in May by 57 top scientists and physicians sent a clear message about COVID vaccines. “The recently identified role of SARS-CoV-2 glycoprotein Spike for inducing endothelial damage characteristic of COVID-19, even in absence of infection, is extremely relevant given that most of the authorized vaccines induce the production of Spike glycoprotein in the recipients. Given the high rate of occurrence of adverse effects, and the wide range of types of adverse effects that have been reported to date, as well as the potential for vaccine-driven disease enhancement, Th2-immunopathology, autoimmunity, and immune evasion, there is a need for a better understanding of the benefits and risks of mass vaccination, particularly in the groups that were excluded in the clinical trials.”
“Despite calls for caution, the risks of SARS-CoV-2 vaccination have been minimized or ignored by health organizations and government authorities.”
“In the context of these concerns, we propose halting mass-vaccination and opening an urgent pluralistic, critical, and scientifically-based dialogue on SARS-CoV-2 vaccination among scientists, medical doctors, international health agencies, regulatory authorities, governments, and vaccine developers.”
Conclusions
Ponder this for a while: Even though we probably have entered vaccine dystopia can we still save humanity and our society?

Impact of Pharmacotherapy on Drug Delivery Systems

Introduction

Pharmacotherapy can be defined as the treatment and prevention of illness and disease by means of drugs of chemical or biological origin. It ranks among the most important methods of medical treatment, together with surgery, physical treatment, radiation and psychotherapy. Although it is almost impossible to estimate the exact extent of the impact of pharmacotherapy on human health, there can be no doubt that pharmacotherapy, together with improved sanitation, better diet and better housing, has improved people’s health, life expectancy and quality of life.

Unprecedented developments in genomics and molecular biology today offer a plethora of new drug targets. The use of modern chemical synthetic methods (such as combinatorial chemistry) enables the synthesis of a large number of new drug candidates in shorter times than ever before. At the same time, a better understanding of the immune system and rapid progress in molecular biology, cell biology and microbiology allow the development of modern vaccines against old and new challenges.

However, for all these exciting new drug and vaccine candidates, it is necessary to develop suitable dosage forms or drug delivery systems to allow the effective, safe and reliable application of these bioactive compounds to the patient. It is important to realize that the active ingredient is just one part of the medicine administered to the patient and it is the formulation of the drug into a dosage form or drug delivery system that translates drug discovery and pharmacological research into clinical practice.

Indeed the drug delivery system employed plays a vital role in controlling the pharmacological effect of the drug as it can influence the pharmacokinetic profile of the drug, the rate of drug release, the site and duration of drug action and subsequently the side-effect profile. An optimal drug delivery system ensures that the active drug is available at the site of action for the correct time and duration.

Drug delivery systems

Drug delivery refers to approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect.

· Drug delivery systems according to the physical state

Based on physical state, drug delivery systems may be:

– Gaseous (e.g. anaesthetics),

– Liquid (e.g. solutions, emulsions, suspensions),

– Semisolid (e.g. creams, ointments, gels and pastes) and

– Solid dosage forms (e.g. powders, granules, tablets and capsules).

· Drug delivery systems according to route of administration

Another way of differentiating dosage forms is according to their site or route of administration.

– Parenteral drug delivery: Drugs can be administered directly into the body, through injection or infusion. Depending on the site of administration into the body it can be differentiated into:

a) Subcutaneous injection

b) Intramuscular injection

c) Intravenous injection

d) Intradermal injection

e) Intraperitoneal injection

– Oral drug delivery: The oral route is the most popular route to administer drugs. Suspensions, tablets, capsules,etc are administered through this route.

– Topical drug delivery: Drugs can also be administered on to the skin to enter into the body. Mostly semisolid dosage forms are used for this, including creams, ointments, gels and pastes. However, liquid dosage forms, such as emulsions, or solid dosage forms, such as transdermal controlled drug delivery systems (patches), can also be used.

– Transmucosal: In this drugs are administered hrough nasal, buccal/sublingual, vaginal, ocular and rectal routes.

· Drug delivery systems according to mechanism of drug release

Another system that can be used to differentiate drug delivery systems is according to the way the drug is released. It can be differentiated as:

– Immediate release – drug is released immediately after administration.

– Modified release – drug release only occurs sometime after the administration or for a prolonged period of time or to a specific target in the body. Modified-release systems can be further classified as:

a) Delayed release: drug is released only at some point after the initial administration.

b) Extended release: prolongs the release to reduce dosing frequency

– Sustained release: These systems maintain the rate of drug release over a sustained period of time.

– Controlled release: Controlled-release systems also offer a sustained-release profile but, in contrast to sustained-release forms, controlled-release systems are designed to lead to predictably constant plasma concentrations, independently of the biological environment of the application site. This means that they are actually controlling the drug concentration in the body, not just the release of the drug from the dosage form, as is the case in a sustained-release system.

– Targeted drug delivery (smart drug delivery): It is a method of delivering medication to a patient in a manner that increases the concentration of the medication in some parts of the body relative to others. The goal of a targeted drug delivery system is to prolong, localize, target and have a protected drug interaction with the diseased tissue.

Disease and Design of drug delivery system

A disease is an abnormal condition that affects the body of an organism. It is often construed as a medical condition associated with specific symptoms and signs. It may be caused by factors originally from an external source, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune diseases, it sometimes includes injuries, disabilities, disorders, syndromes, infections, isolated symptoms, deviant behaviors, and a typical variations of structure and function.

Medical therapies are efforts to cure or improve a disease or other health problem. A number of drug molecules have already been developed but development of further more new drug molecule is expensive and time consuming. So, improving efficacy ratio of “old” drugs is considered a good idea. This has been attempted by developing new drug delivery systems that helps in individualizing drug therapy, dose titration, and therapeutic drug monitoring easily. Delivering drug at controlled rate, slow delivery, targeted delivery are very attractive methods and have been pursued vigorously. Drug delivery systems modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety. It also ensures patient convenience and compliance.

There are some drug molecules which show site specific drug release eg, peptides and proteins. Such drugs cannot show their action without appropriate drug delivery system. So,the increasing number of peptide and protein drugs being investigated demands the development of dosage forms which exhibit site-specific release. Delivery of drugs into systemic circulation through colonic absorption represents a novel mode of introducing peptide and protein drug molecules and drugs that are poorly absorbed from the upper gastrointestinal (GI) tract. Oral colon-specific drug delivery systems offer obvious advantages over parenteral administration. Colon targeting is naturally of value for the topical treatment of diseases of the colon such as Crohn’s disease, ulcerative colitis and colorectal cancer. Sustained colonic release of drugs can be useful in the treatment of nocturnal asthma, angina and arthritis. Peptides, proteins, oligonucleotides and vaccines are the potential candidates of interest for colon-specific drug delivery. Sulfasalazine, ipsalazide and olsalazine have been developed as colon-specific delivery systems for the treatment of inflammatory bowel disease (IBD).

Worldwide, over 40 million people are infected with the Human Immunodeficiency Virus (HIV). The High Activity Antiretroviral Therapy (HAART) combines at least three antiretroviral (ARV) drugs and, for over a decade, has been used to extend the lifespan of the HIV-infected patients. Chronic intake of HAART is mandatory to control HIV infection. The frequent administration of several drugs in relatively high doses is a main cause of patient incompliance and a hurdle toward the fulfillment of the pharmacotherapy. High adherence to HAART does not lead to complete HIV virus elimination from the host. Intracellular and anatomical viral reservoirs are responsible for the perpetuation of the infection. Active transport mechanisms involving proteins of the ATP-binding cassette superfamily prevent the penetration of ARV drugs into the brain and may account for the limited bioavailability after oral administration. A new research that addresses from simple organoleptic or technological problems to more complex issues involving the targeting of specific tissues and organs has emerged. With the aim to reduce dosing frequency, to improve the compliance of the existing pharmacotherapy and to target viral reservoirs, the design of drug delivery systems is becoming complementary to new drug discovery.

Conclusion

Whenever a person suffers from a disease, he/she requires a medical treatment and every one of us prefer the safe, effective, economic and a convenient one. This can only be achieved by development of appropriate drug delivery system. No matter how dosage forms are classified, the role of the drug delivery systems is to allow the effective, safe, and reliable application of the drug to the patient.

For the proper Pharmacotherapy, delivery systems should allow and facilitate the drug to reach its target site in the body. For example, a tablet formulation containing an antihypertensive drug must disintegrate in the gastrointestinal tract, the drug needs to dissolve and the dissolved drug needs to permeate across the mucosal membrane of the gastrointestinal tract into the body. So, for the development of dosage forms the formulation scientist needs to optimize the bioavailability of the drug.

Similarly, the delivery system is to allow the safe application of the drug. This includes that the drug in the formulation must be chemically, physically and microbiologically stable. Side-effects of the drug and drug interactions should be avoided or minimized by the use of suitable drug delivery systems. The delivery systems also need to improve the patient’s compliance with the pharmacotherapy by the development of convenient applications. For example, one can improve patient compliance by developing an oral dosage form where previously only parenteral application was possible.

Finally, the delivery system needs to be reliable and its formulation needs to be technically feasible. However, for any application of a drug delivery system on the market, the dosage form needs to be produced in large quantities and at low costs to make affordable medicines available. Therefore, it is also necessary to investigate the feasibility of the developed systems to be scaled up from the laboratory to the production scale.