Hemorrhagic stroke is caused by a sudden ruptured blood vessel that leads to bleeding into or around the brain. Hemorrhagic stroke is the second most common cause of stroke and is responsible for five percent of all deaths in the United States.2 The main risk factors for hemorrhagic stroke are hypertension, older age, anti-coagulant medications, smoking and high alcohol intake, cerebral amyloid angiopathy, coagulation factor deficiency and a family history of hemorrhagic stroke. Approximately 3.6 million people worldwide suffer a hemorrhagic stroke each year. Approximately 250,000 people suffer a hemorrhagic stroke in the European Union and approximately 210,000 people suffer a hemorrhagic stroke in the United States annually. Of the total number of hemorrhagic strokes in the European Union and the United States, more than 40 percent are surgically operated.3 This implies that approximately 190,000 cases of hemorrhagic stroke in the European Union and the United States are eligible for IRRAflow treatment.
Seventy-five percent of all hemorrhagic strokes occur in people aged over 65 in the European Union and in the United States.4 The number of hemorrhagic stroke events in the European Union is expected to increase by 34 percent by the year 20355 and, similarly, the number of hemorrhagic stroke events in the United States is expected to increase by 24 percent by the year 20306, primarily as a result of the aging population.
Approximately 40 percent of all hemorrhagic stroke cases result in death within 30 days, and approximately one-third of cases result in brain damage and permanent disability7. The estimated direct health costs and indirect costs due to the opportunity cost of informal care by family and friends and lost productivity caused by morbidity or death of hemorrhagic stroke was EUR 45 billion in the European Union8 and USD 33 billion in the United States.9
The World Health Organization predicts that disability-adjusted life years (DALYs) lost to hemorrhagic stroke (a measure of the burden of disease) globally will rise from 5.7 million in 1990 to 9.2 million in 2020.10
Chronic Subdural Hematoma
Subdural hematoma occurs when a vein or other blood vessels rupture between the skull and the outermost membrane layer that covers the brain, resulting in the collection of blood (a hematoma) on the brain’s surface which compresses the brain tissue. There are three types of subdural hematoma: Acute, subacute and chronic. IRRAflow is currently being marketed to treat chronic subdural hematomas, which comprise approximately 30 percent of all subdural hematomas in the United States. Chronic subdural hematomas are generally caused by moderate head injuries, particularly in individuals who are elderly or on anticoagulant medication. Symptoms gradually appear within several weeks after the first bleeding. The main risk factors for subdural hematoma are aspirin or other anticoagulant medication, older age, high alcohol intake and previous traumatic brain injury. Each year there are an estimated 80,000 chronic subdural hematoma cases in the European Union and approximately 80,000 cases in the United States. Of the total amount of chronic subdural hematoma cases in the European Union and the United States, more than 95 percent are surgically operated.11 This implies that approximately 155,000 cases of chronic subdural hematoma in the European Union and the United States are eligible for IRRAflow annually.
Approximately one-third of all chronic subdural hematoma patients die and another one-third become permanently disabled.12 The total estimated direct healthcare cost associated with chronic subdural hematoma in the United Kingdom alone is USD 1.6 billion.13 Chronic subdural hematoma is projected to become the most common cranial neurosurgical condition by the year 2030 which in turn could mean that chronic subdural hematoma fluid drainage may become the most commonly performed neurosurgical procedure.14
2 American Heart Association Report: Heart Disease and Stroke Statistics—2017 Update.
3 Anticoagulation Society Europe Report, Univ.-Prof. Dr. Johann Willeit, Universitätsklinik für Neurologie, Medizinische Universität Innsbruck, 2015.
4 European Heart Network Report: European Cardiovascular Disease Statistics 2017 edition
5 SAFE Report: The Burden of Stroke in Europe
6 American Heart Association Report: Heart Disease and Stroke Statistics—2017 Update
7 Marc Fisher MD, Bo Norrving MD, PhD, “American Heart Association, 1st Global Conference on Healthy Lifestyles and Noncommunicable Diseases Control Moscow”, 28-29 April, 2011 “The International Agenda for Stroke”
8 SAFE Report: The Burden of Stroke in Europe, 2017.
9 American Heart Association Report: Heart Disease and Stroke Statistics—2017 Update
10 WHO report: The Global Burden of Stroke, 2013.
11 Anticoagulation Society Europe Report, Univ.-Prof. Dr. Johann Willeit, Universitätsklinik für Neurologie, Medizinische Universität Innsbruck, 2015.
12 WHO report: The Global Burden of Stroke, 2013.
13 The epidemiology of surgically treated acute subdural and epidural hematomas Can J Surg. 2008 Oct;51(5):339-45. Tallon JM, Ackroyd-Stolarz S, Karim SA, et al.
14 Neuroscience Intensive Care Unit, Department of Neurosurgery, Mount Sinai School of Medicine, New York, NY, USA Report: National trend in prevalence, cost, and discharge disposition after subdural hematoma from 1998-2007