Currently, less than one in ten patients suffering from an ischemic stroke receives thrombectomy, due in part to a lack of scientific evidence supporting treatment beyond six hours.
The results shown in the DAWN trial have the potential to fundamentally change the paradigm of care for stroke patients globally.
The DAWN Trial reflects Stryker's commitment to clinical leadership and focus on patient pathway development.
Sponsored by Stryker, the trial was designed to evaluate functional outcomes at 90 days in stroke patients treated with mechanical thrombectomy using the Trevo Retriever compared to those receiving medical therapy alone.
Patients were screened for inclusion in the trial if they had a stroke that started within six to 24 hours, or a stroke with an unknown time of onset--a significantly longer treatment window than the currently cleared thrombectomy indication.
Stryker's Trevo Retriever is a tiny stent-shaped medical device that is attached to a thin wire. In a minimally invasive procedure that utilizes X-ray, the physician navigates the retriever from the femoral artery (located in the upper leg) to the blocked blood artery in the brain.
The retriever is designed to ensnare the blood clot and remove it from the body. Originally cleared by the FDA in 2012 for the revascularization of patients experiencing ischemic stroke, the Trevo Retriever has been used in thousands of patients worldwide.
The retriever's indication within the DAWN Trial, for use in patients treated six to 24 hours after last seen well, is currently under an Investigational Device Exemption only. The Trevo Retriever was the only mechanical thrombectomy device used in the DAWN Trial.
An ischemic stroke occurs when an artery in the brain becomes blocked by a blood clot or other substance such as plaque, a fatty material. Blood vessels carry blood, oxygen and nutrients throughout the body and to the brain.
When the brain is deprived of blood and oxygen, it fails to work properly. Depending on the severity of the stroke and the area of the brain affected, loss of brain function or death may occur.
According to the World Heart Federation, ischemic stroke contributes to 6m deaths around the globe.
Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better.
The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
Saluda Medical secures CE certification for EVA Sensing Technology in Europe
Antin to acquire clinical trial equipment provider Emsere
Hyphens Pharma licenses Cerapro skin cream to Louis Widmer for six European markets
Profusa signs French distributor to expand Lumee Oxygen rollout in Europe
Sensiva Health names new chief operating officer
BrioHealth Solutions enrols 100th participant in BrioVAD System trial
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
BioCryst wins FDA approval for oral HAE prophylaxis in young children
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Galderma secures EU MDR certification for Sculptra, expanding use to multiple body areas
Clinical Laserthermia Systems applies for CE marking of ClearPoint Prism neuro laser system