Medical company Stryker revealed on Thursday the receipt of the US Food and Drug Administration's (FDA) expanded indication for Trevo Retriever for the front-line treatment of patients experiencing acute ischemic stroke up to 24 hours from symptom onset – increasing the treatment window by 18 hours.
An ischemic stroke occurs when an artery in the brain becomes blocked by a blood clot or other substance such as plaque. 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.
The company said the Trevo Retriever is a tiny stent-shaped medical device that is attached to a thin wire. In a minimally invasive procedure that utilises X-ray, the physician navigates the retriever from the femoral artery 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 US FDA in 2012, the Trevo Retriever has been used in thousands of patients worldwide.
This US FDA's expanded indication of the company's clot-removal device is in line with the recent updated treatment guidelines from the American Heart Association and American Stroke Association and has the potential to reduce disability and improve quality of life for additional stroke patients each year.
Until now, the Trevo Retriever were only cleared for use up to six hours from symptom onset. However, recent randomised clinical data from the Stryker-sponsored DAWN Trial shows that patients presenting in the six- to 24-hour window who meet specific imaging criteria and are treated with the Trevo Retriever are almost four times as likely to be functionally independent at 90 days post-stroke, compared to those treated with medical management alone.
Microbot Medical secures first Japanese patent for Liberty robotic system following FDA clearance
Polarean Imaging signs new supply agreementwith UVA Health for clinical Xenon MRI
Femasys partners with Kebomed to expand FemBloc permanent birth control in France and Benelux
Implantica receives positive FDA feedback on final RefluxStop PMA submission
Tempus secures FDA clearance for RNA-based xR IVD diagnostic device
Shoulder Innovations expands I-Series portfolio with launch of InSet 70 Humeral Stem
GSK commits USD30bn to US R&D and manufacturing expansion
ArtPlayer Promotes Elderly Wellbeing with Digital Signage and Streaming Art in Finnish Care Homes
Implantica produces 10,000 RefluxStop units ahead of planned US launch
Elute partners Spartan Medical
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Abbott's Navitor TAVI system granted CE Mark for expanded indication
PharmaResearch names VIVACY as European distribution partner for Rejuran
Airiver medical receives FDA approval for central airway stenosis trial