Release date: 2016-09-08 On September 2, 2016, the US Food and Drug Administration (FDA) issued a statement approving two mechanical thrombectomy devices that can be used in combination with tissue plasminogen activator (tPA) for acute deficiency. Initial treatment of bloody stroke. The approved equipment is the Trevo ProVue and revo XP ProVue plugging devices, all produced by Concentric Medical. In 2012, the device was used in patients with acute ischemic stroke who were unable to receive tPA thrombolysis or who did not respond to tPA to reconstitute the patient's cerebral blood flow. This approval has expanded the indications for the device, but the device is only available after tPA administration and is used within 6 hours of the onset of symptoms. The Trevo thrombectomy device is inserted through the catheter into the occluded blood vessel, and the distal end has an expandable wire mesh for gripping the blood clot, and the doctor can pull the blood clot together with the extraction device through the catheter or cannula. This new FDA approval of the device is based on a randomized selection of patients. The study compared the prognosis of 96 experimental groups and 249 control patients. The experimental group was treated with this device and tPA, and the blood pressure and symptoms were medically managed. The control group only used tPA and medical management. The results of the study showed that 29% of patients in the group using the Trevo device for thrombectomy achieved independence after 3 months of stroke, compared with 19% of those who did not receive thrombolysis. Of course, there are certain risks associated with the use of the device, such as failed thrombectomy, device rupture, and perforation or bleeding due to problems with intravascular navigation. In the new statement, the director of the US FDA's neurology and physical medical equipment said: "This is the first time the FDA has approved a device for use with tPA. The approval of the device may help to further reduce it compared to the use of tPA alone. Disability-related disability. Now, medical service providers and patients have a new stroke treatment tool." Original search FDA allows marketing of clot retrieval devices to reduce disability in stroke patients Source: Medical Pulse
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