Cleveland Clinics announced the list of Top Ten Medical innovations of 2015. The list contains treatments and technologies that are expected to significantly change patient care and save lives and have a significant impact on a large part of the population.
The process starts with a panel of
Cleveland Clinic physicians and scientists who submit their ideas. These
suggestions, which Roizen said totaled about 700 for the 2015 list, are
then narrowed down and voted on by 40 physicians in a variety of health
fields.
Here's what they selected for 2015:
Each year in the United States, nearly 800,000
people suffer a stroke, or a brain attack.
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| The Mobile stroke unit |
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| The inside of the mobile stroke unit |
Strokes occur frequently: Once every 40 seconds, while every
four minutes an American dies from stroke complications. Stroke is now the
fourth leading cause of death in this country—and number one in much of the
world. Although many people survive a stroke, even multiple episodes, stroke is
still the number one cause of disability.
With the FDA approval in 1996 of the emergency stroke drug,
tissue-type plasminogen activator, or r-tPA, doctors finally had a treatment
for ischemic stroke—the most prevalent kind—that could effectively break up a
blood clot that was hindering blood flow to the brain.
Time lost is brain lost and every second counts for stroke
victims: Each minute that goes by, it’s estimated that two million brain
cells die. The faster t-PA is given after a stroke, the more effective and
safer it is. Best given within an hour of arrival at a hospital, the
intravenous drug may still be used in select patients up to 4.5 hours from
symptom onset. The problem is that only 2 to 7 percent of people eligible for
tPA ever get the clot-busting drug in this country
In order to improve stroke outcomes, a few hospitals in
Germany and the United States are now using specially equipped mobile stroke
treatment ambulances outfitted with all the necessary elements for the
emergency evaluation and treatment of stroke and taking them on the
road—bringing the highest level of care directly to the patient.
These high-tech ambulances, with onboard paramedic, critical care nurse, EMT,
CT technologist, and virtual stroke neurologist (via telemedicine) are now
bringing the emergency department straight to the patient with stroke
symptoms—wherever he or she may be.
The goal is to preserve optimal brain function by performing
a neurological evaluation, making an accurate diagnosis and administering tPA
as soon as possible, occasionally as fast as 11 minutes after arrival on the
scene. This prevents and often reverses the effects of stroke before they can
lead to permanent brain injury.
The faster an ischemic stroke is recognized, the faster effective treatment can
be administered. With the mobile stroke treatment unit, a special portable
computed tomography (CT) scanner takes brain images in two minutes, which are
then rapidly sent via a 4G broadband wireless link to hospital neurologists and
neuroradiologists to interpret and yield a diagnosis. These doctors then prescribe
and direct the treatment of the patient via the video hookup, and then triage
the patient based on stroke type and severity to the appropriate hospital
resource in the area.
After an ischemic stroke is detected, tPA therapy begins immediately in the
ambulance, well before arrival at the hospital, dramatically cutting the time
from diagnosis to treatment. Thanks to the mobile stroke unit, many survivors
recover fully and regain their previous levels of function.
Mobile stroke treatment units have been in use in Ohio and Texas
for over a year now, and have shown significant improvements in stroke
treatment times. Studies examining patients who use the mobile stroke unit
found that CT scans were accomplished 20 minutes sooner and the total treatment
time was significantly reduced from an average of 104 minutes in the emergency
room to 64 minutes. There is an ongoing study to determine the
cost-effectiveness of this treatment option.
The
World
Health Organization reports that about half of the world's population is
now at risk for dengue fever, and it is the fastest growing of all the mosquito
born illnesses.
The biology of Dengue is very complex and has baffled
researchers for decades.
A primary difficulty is that a vaccine would have to
prevent four different but closely related viruses simultaneously—serotype 1,
2, 3, and 4. And while people can get infected with any virus, or all of them,
immunity against one serotype does not provide immunity against any of the
other three. Moreover, the prevalence of serotypes varies from region to region
around the globe.
The world’s first vaccine against the dengue scourge
has now been developed and tested. The vaccine worked in just-completed Phase
III trials of children 2 to 14 in five areas across Asia.
Almost 60 percent of the 6,000 children were protected against the disease
compared to placebo injections after a three-shot, two-year period.
After 20 years of research, the dengue vaccine was
made commercially available in the Philippines starting October 2015,
with the potential to save the Philippian government $8.2 billion per year.
Commercialization is expected to follow in 2016 for other countries where
dengue hits hardest.
A new painless, more accurate, faster, and
significantly less expensive blood testing method has arrived.
Gone are the needles and vials, replaced instead by a proprietary software and
hardware technology that uses but a drop of blood from the capillaries at the
end of a finger in a virtually painless procedure. The blood sample is wicked
into a special nanotainer, which holds the equivalent amount of a raindrop.
Shipped to a special CLIA-certified laboratory,
hundreds of different tests can now be performed from that one drop of blood,
from standard cholesterol checks to sophisticated genetic analyses.
Blood results are then sent back to the requesting physician in a matter of
hours. When further testing is needed, it can be done immediately, again with
the same tiny blood sample.
Ultimately this enhanced diagnostic process will provide better information so
diseases can be caught in their earliest stages, and treatment begun quickly.
Receiving FDA approval in June 2015, this blood
testing platform that only needs a drop of blood now offers over 153 tests for
under $10 each, usually at 50% of the typical insurance copay. After a recent
deal, consumers can now get these tests performed at various drugstore
locations across the nation.
New self-injectable drugs called PCSK9 inhibitors
have shown to be very effective in lowering cholesterol. These drugs may prove
to be helpful for people with high LDL cholesterol who don't have good results
with
statins. The FDA has approved the first PCSK9 in
2015.
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| Praluent is a new injectable drug approved by the FDA to lower cholesterol. |
There are now the PCSK9 inhibitors, a new class of
cholesterol-lowering drugs that are self-injected once or twice a month. The
medications work on the cholesterol receptor in the liver by a mechanism that
is similar to statins, yet completely unique. The drugs not only reduce LDL
cholesterol levels dramatically, but also take them to super low levels never
seen before.
Study results with these complex monoclonal antibodies have reported promising
data, with LDL cholesterol levels plummeting by as much as half to two-thirds
in patients taking the medication versus those taking placebo. And when a PCSK9
was taken along with a statin, LDL levels were reduced by 75 percent.
There are now several PCSK9 drugs currently in various stages of development. This
new class of cholesterol-reducing drug was approved by the FDA Advisory Board
in June 2015. Doctors are ready to prescribe this drug to 17% of their patients
with dangerously high LDL levels, potentially creating a $3 billion market.
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| courtesy: adcreview.com |
A welcome breakthrough in the world of cancer
treatment, antibody-drug conjugates can deliver targeted treatment without
damaging healthy tissue.
The century-old dream of creating magic bullets to
fight cancer is almost here. Antibody-drug conjugates represent a promising
therapeutic approach for advanced cancer patients by combining the
antigen-targeting specificity of monoclonal antibodies with the cytotoxic
potency of chemotherapeutic medications that specifically target a protein only
found in or around tumor cells, and then using this drug combination to destroy
tumors. Think precision killing with fewer side effects.
With over two dozen antibody-drug conjugates
currently in clinical trials for solid tumors and blood cancer, as well as
potent FDA-approved drugs for advanced HER2-positive breast cancer and
Hodgkin’s lymphoma already available, it is becoming clear that these smart
bombs, the antibody-drug conjugates, are becoming an important and viable
approach for selectively delivering highly cytotoxic agents to tumor cells
while avoiding damage to normal tissue.
Currently there are over 350 antibody drug conjugates
(ADCs) being developed to fight cancer, with previously approved drugs in
trials to prove efficacy against a larger variety of cancers. Many
pharmaceutical and research companies are investing millions of dollars into
the growing ADC market, which is projected to reach $3 billion by 2018.
Immune checkpoint inhibitors have been shown to
prevent cancer cells from "hiding" from the immune system, allowing
the body to more effectively fight these abnormal cells. Combined with
chemotherapy and radiation treatment, the drugs have shown significant,
long-term cancer remissions for patients with
metastatic melanoma, one of the most deadly forms of
cancer.
Recently, however, interest in using the body’s
immune system in the war on cancer has been heightened by the remarkable
results achieved by a class of drugs called immune checkpoint inhibitors. These
intravenous immunomodulators effectively block the action of proteins that act
as brakes, or checkpoints, on cells, which allow cancer cells to hide from the
immune system and survive. Once freed by the special checkpoint inhibitors, however,
this permits certain white cells of the immune system, the killer T cells, most
notably, to carry out their lethal attacks on marauding cancer cells.
Researchers are now combining checkpoint inhibitors
with either chemotherapy or radiation in treating lung cancer, gastric cancer,
pancreatic cancer, kidney, and breast cancer. By directly killing cancer cells
with radiation or chemotherapy, it’s hypothesized that the addition of
immunotherapy will help create special T cells that will remain and will be able
to recognize and kill any returning cancer cells long after the initial
treatment has stopped. With two drugs already approved for metastatic melanoma
by the Food and Drug Administration (FDA), one of them two months earlier than
expected, there is now increasing evidence that checkpoint inhibitors can work
on a growing number of types of malignancies, including lung, kidney, bladder,
ovarian, and head and neck cancers.
Three immune checkpoint inhibitors have been approved
for use in patients with melanoma with sales of over $1.5 billion in 2014, and
one has been granted priority review for use in lung cancer patients with its
approval expected in 2016. Additionally, there are over 80 companies
researching 148 immune checkpoint inhibitors associated with various cancers,
with 10 in the last phase of clinical trials.
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| courtesy: emory.edu |
Until this point, wires have been a necessary
component in pacemakers. A new wireless pacemaker about the size of a vitamin
can now be implanted in the heart without surgery. Its lithium-ion battery is
estimated to last about seven years.
This wireless cardiac pacemaker that’s no bigger than
a large vitamin is 10 percent the size of a traditional pacemaker. In the space
of 15 to 30 minutes, the miniaturized battery-controlled device can be
implanted directly in the heart without surgery by steering it through a
femoral vein and up into the heart’s right ventricle.
Secured in place by prongs or a screw, a sensor electrode in the metal-clad
device detects all heart rate information and relays it to the generator, which
provides the necessary cardiac stimulation to keep the heart in regular rhythm.
Lithium battery life is estimated to be seven years or longer with the current
miniaturized devices. The entire wireless pacemaker is fully retrievable via a
catheter and a new one can be inserted when the battery wears out. Or, in lieu
of replacement, another leadless pacemaker may simply be implanted when needed.
This pacemaker nanotechnology has eliminated surgery, lumps and scars on
patient’s chest, restrictions on daily physical activities, as well as any
complications stemming from any malfunctioning insulated connecting leads.
Not yet approved in the United States by the Food and Drug
Administration (FDA), late-stage clinical trials of several leadless pacemakers
for patients experiencing heart rhythm issues are now ongoing testing at scores
of sites around the country, each in pursuit of FDA approval.
Two leadless pacemaker devices have now received the
CE mark in Europe and are completing final stage trials in the US, with FDA
approval expected in 2016.
Idiopathic pulmonary fibrosis is a life-threatening disease
that causes scarring in the lungs, leading to breathing difficulties and a
shortage of oxygen in the brain and other organs. Life expectancy is only three
to five years after diagnosis, but those numbers may change now that the FDA
has approved two experimental drugs that slow the disease: pirfenidone and
nintedanib. There is now new hope for patients with IPF. Two new drugs have
been proven in large international studies to significantly slow the progress
of IPF.
The first oral drug, pirfenidone, slowed the disease progress after just 13
weeks of treatment in the one-year study compared to placebo therapy. The drug
also enhanced lung function significantly, and improved the distance that a
patient could walk. Overall, the drug reduced the risk of mortality by 48
percent compared to placebo.
While researchers aren’t sure how pirfenidone works against IPF, the drug
appears to have anti-inflammatory properties and it also inhibits a growth
factor protein in the development of fibrosis. The drug is already approved for
use in Europe, Japan, and Canada, and the FDA just approved its use in the
U.S.
In two Phase III studies of more than 1,000 patients, the second drug,
nintedanib, reduced patients’ annual rate of lung function decline by 48
percent and 55 percent, compared to 5 percent for those taking placebo drug.
Nintedanib works by blocking the effect of tyrosine kinases, important proteins
that alert the lungs to make scar tissue. Thanks to the FDA’s breakthrough
therapy designation that guarantees speedy priority review, this drug was also
recently approved for use in the United States.
Two new drugs in one year. People with IPF will finally be able to breathe
easier.
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| Intrabeam radiotherapy treatment ( IORT) |
The
National Cancer Institute estimates that 40,000 women in the United States
will die from breast cancer in 2014. The Cleveland Clinic cites multiple
chemotherapy appointments, sometimes requiring the patient to travel long
distances, as a hindrance to successful treatment. Intraoperative radiation
therapy is a new solution. It treats a breast cancer tumor during surgery in a
single dose, reducing time and cost spent on treatment.
A new advancement in breast cancer radiation therapy called intraoperative
radiation therapy, or IORT, is a promising treatment that may help alleviate
some of this burden for women with early-stage disease.
Used successfully for decades with a different type of radiation therapy as
part of treatment for intra-abdominal cancers, a new type of IORT is now being
used to deliver high doses of radiation during lumpectomies, concentrated only
in the cavity where tumors were removed.
After excising the tumor and surrounding tissue from the breast, radiation is
delivered through an applicator directly to the former tumor’s site, where the
risk of cancer recurrence is highest.
Shielding of the rest of the body is not required as the radiation is focused
only in the lumpectomy cavity and the focused radiation does not damage the
heart or lungs—as can happen with whole breast radiation. After about 30
minutes of treatment, the applicator is removed.
The single dose of intraoperative radiation delivers a single very high dose of
radiation to the area around the lumpectomy cavity—different from traditional
whole breast radiation, which delivers multiple small doses over many days.
Based on the results of a large clinical trial, focusing the radiation on the
tumor bed, IORT has been shown to be as effective as whole breast radiation for
selected patients with early stage breast cancer: the rate of cancer recurrence
is comparable after both forms. The study also showed the risk of skin toxicity
is decreased after IORT compared to conventional radiation therapy.
Intraoperative radiation therapy is significantly less costly than standard
whole breast radiation treatment. And with fewer trips made to the hospital for
radiation therapy planning and radiation therapy and less time spent in
treatment, intraoperative radiation therapy provides a significant boost to the
quality of life for patients with early stage breast cancer.
IORT for a subset of breast cancer patients is a great alternative to save
time and stress caused by traditional whole breast external beam radiation
therapy, which usually consists of multiple sessions over a course of 3 weeks.
However, recurrence rates for IORT patients were found to be at least double
those of EBRT patients, and doctors are exercising caution while awaiting
long-term study results before adopting this new method as a standard of care.
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About 5.1 million people in the United States suffer from heart
failure, according to the
National
Heart, Lung and Blood Institute. It is managed with a combination of drugs,
but a new drug, angiotensin-receptor neprilysin inhibitor, has been granted
fast-track status by the FDA because of its ability to cut the risk of dying
from heart failure more effectively than current treatments.
Even though great strides have been made in diagnosis
and treatment, the prognosis remains poor for people with heart failure. Less
than 50 percent of patients are living five years after their initial diagnosis
and less than 25 percent are alive at 10 years.
The consistent use of ACE (angiotensin-converting
enzyme) inhibitors, which dilate blood vessels and allow the heart to function
more efficiently along with the beta-blockers, which decrease the workload of
the heart, has cut the risk of dying from heart failure in half.
However, there is now an experimental heart failure drug that has completely
surprised the world of cardiology.
Used in an international study carried out with more than 8,000 patients in 47
countries, the largest ever heart failure study was stopped seven months early
because a data review showed that this novel twice-daily drug reduced
cardiovascular death rates or hospitalization due to heart failure by 20
percent compared to standard treatment with the ACE inhibitor enalapril, a
generic drug that is one of the most widely prescribed treatments. And it also
reduced the risk of death due to any cause 16 percent compared with the group
taking enalapril.
The investigational drug, called an angiotensin-receptor neprilysin inhibitor,
or ARNI, combines sacubitril, a neprilysin inhibitor, with angiotensin receptor
blocker (ARB), and it improved outcome in patients who were currently receiving
the best possible therapy.
In the study, this drug proved superior to the gold standard ACE inhibitor—and
the gold standard dose—for heart failure.
This unique drug compound, which saves lives, reduces long-term health costs,
and makes people feel better, may represent not only a major advance in
pharmacological treatment but also a completely new paradigm shift in heart
failure therapy.
The impressive survival advantage study finding provides strong support for
using the new drug instead of ACE inhibitors in the treatment of chronic heart
failure. Granted Fast Track status by the Food and Drug Administration, the
heart drug was made available in 2015 in the United States.
In studies, this drug was found to reduce risk
of cardiovascular death by 20% and HF related hospitalization by 21% when
compared to standard treatment. While this treatment option is projected to be
more expensive than current standard care, sales are expected to be in the
billions by 2019.
References:
http://www.cnn.com/2014/10/31/health/cleveland-clinic-medical-innovations/
