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HLCCompendium
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NDHI<br />
NAT IONAL DIALOGUE FOR<br />
Healthcare Innovation<br />
Making Healthcare Better<br />
Through Innovation in Stroke<br />
Patient Management<br />
Organization Overview<br />
Stryker is a leading global medical technology company<br />
that is driven to work together with their customers to<br />
make healthcare better.<br />
Background<br />
An ischemic stroke occurs when a blood clot or other<br />
substance such as plaque, a fatty material, blocks the<br />
blood flow through an artery in the brain. Arteries carry<br />
essential blood, oxygen and nutrients from the heart<br />
to the brain. When the brain is deprived of blood and<br />
oxygen, its cells begin to die and the patient begins<br />
to lose ability to complete the activities those cells<br />
managed. Depending on the severity of the stroke<br />
and the area of the brain affected, permanent loss of<br />
brain function or patient death may occur. Ischemic<br />
stroke affects 650,000 Americans annually and is the<br />
number five cause of death. There are over 7 million<br />
stroke survivors in the United States, two thirds of<br />
whom are living with moderate to severe disability.<br />
30% are unable to walk without assistance, 50% have<br />
some level of partial paralysis and 19% have trouble<br />
finding words when they speak.<br />
About one third of all ischemic strokes, or roughly<br />
215,000, involve blockage of a large blood vessel, known<br />
as a large-vessel occlusion (LVO). LVOs can be the<br />
most devastating and most difficult to successfully treat<br />
because they cut off blood flow to such large portions<br />
of the brain. During an LVO stroke, 1.9 million neurons,<br />
14 billion synapses and 12km of myelinated fibers<br />
are destroyed every minute. As the U.S. population<br />
continues to age, stroke will become an even more<br />
common disease and an increasing cost burden on<br />
the healthcare system.<br />
In stroke, evidence shows that the more quickly a<br />
medical intervention is administered, the better the<br />
outcome is for the patient. This concept is referred to by<br />
researchers and clinicians as “time is brain,” meaning<br />
the less time to treatment the less brain function is lost.<br />
Stryker manufactures a product called the Trevo ®<br />
Retriever which physicians use to capture and remove<br />
a clot, restoring blood flow to a patient’s brain, during<br />
a procedure called thrombectomy. Trevo ® is cleared<br />
by the FDA as an initial therapy to reduce disability<br />
in stroke patients. Trevo’s disability indication is for<br />
LVO patients also receiving IV lytics who can have a<br />
thrombectomy within 6 hours of stroke onset. Trevo<br />
also has a mechanical indication allowing it to be used<br />
for clot removal in patients who are ineligible for or<br />
have failed IV lytic therapy up to 8 hours post stroke<br />
onset. Trevo ® is the first therapy in 20 Years to be<br />
declared a front-line treatment to reduce disability<br />
in ischemic stroke.<br />
In spite of overwhelming clinical evidence, ASA guidelines<br />
and FDA indications all supporting thrombectomy as<br />
a primary treatment of LVO stroke, only about 1 in 10<br />
eligible patients receives thrombectomy in the United<br />
States. There are two major infrastructure-related<br />
barriers to timely and effective stroke treatment today:<br />
1.) Scarcity of hospitals: Fewer than 600 hospitals in<br />
the United States have the ability to perform stroke<br />
thrombectomy. With half of stroke patients transporting<br />
themselves to hospitals instead of calling 9-1-1, most<br />
patients begin their care journey at a hospital that<br />
cannot provide the standard of care treatment for LVO.<br />
This necessitates a rapid, efficient system of patient<br />
triage and transfer between hospitals.<br />
An Initiative of the<br />
105 |<br />
Making Healthcare Better Through Innovation in Stroke Patient Management