December 30, 2016
Kalamazoo, Michigan, USA – Sept. 6, 2016 – The Food and Drug Administration (FDA) expanded on Sept. 2 the indication for Stryker’s Trevo Retriever as front-line treatment to reduce disability in patients experiencing acute ischemic stroke. Trevo is the first and only thrombectomy device to receive this expanded indication, which has the potential to help the hundreds of thousands of Americans who experience ischemic strokes—or brain attacks—each year.
People suffering from stroke commonly experience devastating disabilities and loss of independence due to impaired movement, paralysis, loss of speech and memory. Randomized clinical data using the Trevo retriever alongside IV t-PA shows that patients are almost twice as likely to be functionally independent at 90 days after a stroke compared to medical management alone.1 The strength of this data resulted in Trevo receiving the first and only FDA clearance for a thrombectomy device to significantly reduce disability in patients with ischemic stroke. This clearance for front-line use expands the treatment with Trevo to a broader group of patients.
“This new and unique indication for Trevo, as initial therapy for acute ischemic stroke with large vessel occlusions, has the potential to help hundreds of thousands of stroke patients,” said Amrou Sarraj, MD, assistant professor of Neurology and Vascular Neurology Fellowship Program Director at the University of Texas Health Science Center at Houston. “These patients now have a significantly better chance for an independent life without disability.”
Mari, an elementary school teacher and mother of twin boys, suffered an ischemic stroke in June of 2015. She received treatment with the Trevo Retriever at the Stroke and Neurovascular Center of Central California in Santa Barbara, Calif., within hours of her symptoms starting. She recalls, “I couldn’t speak and I was quickly losing feeling on one side of my body. If there hadn’t been a treatment option like Trevo, the blood clot might still be blocking the artery in my brain and I wouldn’t be capable of living the active lifestyle I have today.”
“This expanded indication for Trevo is a significant milestone in the treatment of patients who are suffering from this catastrophic disease and is an example of the strength of evidence for the Trevo device coming from randomized clinical trials,” said Mark H. Paul, president of Stryker’s Neurovascular division.”
“So many patients with major ischemic stroke due to large vessel occlusions still go untreated today, largely ending up with a devastating long term disability,” said Dr. Sarraj. “The FDA clearance of the Trevo Retriever as a front-line treatment to reduce disability reinforces the importance that all caregivers in the stroke pathway – from EMS to emergency room physicians to Neurologists to interventionalists – continue to come together to deliver fast and efficient treatment of stroke.”
Based on the depth of clinical evidence, the Trevo Retriever is also included in the recent American Heart Association’s 2015 stroke care guideline update where stent retrievers are now recommended as the standard of care for stroke patients experiencing a large artery blockage.2
The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal, anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV-tPA). Endovascular therapy with the device should start within 6 hours of symptom onset.
The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within eight hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV-tPA) or who fail IV-tPA therapy are candidates for treatment.
The 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, which is 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 in patients experiencing ischemic stroke, the Trevo Retriever has been used in thousands of patients worldwide. An animation of Stryker’s Trevo Retriever is available here: https://youtu.be/PxcERzyI67I
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. Ischemic stroke affects nearly 795,000 Americans annually and is the number five cause of death.3
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.
Potomac Communications Group
Kelly Cousineau, email@example.com, 805-335-0152
INDICATIONS FOR USE
Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with possible complications which may occur during or after the procedure. Possible complications include, but are not limited to, the following: air embolism; hematoma or hemorrhage at puncture site; infection; distal embolization; pain/headache; vessel spasm, thrombosis, dissection, or perforation; emboli; acute occlusion; ischemia; intracranial hemorrhage; false aneurysm formation; neurological deficits including stroke; and death.
3x20mm retrievers are compatible with Trevo® Pro 14 Microcatheters (REF 90231) and Trevo® Pro 18 Microcatheters (REF 90238). 4x20mm retrievers are compatible with Trevo® Pro 18 Microcatheters (REF 90238). 4x30mm retrievers are compatible with Excelsior® XT-27® Microcatheters (150cm x 6cm straight REF 275081) and Trevo® Pro 18 Microcatheters (REF 90238). 6x25mm Retrievers are compatible with Excelsior® XT-27® Microcatheters (150cm x 6cm straight REF 275081). Compatibility of the Retriever with other microcatheters has not been established. Performance of the Retriever device may be impacted if a different microcatheter is used.
Balloon Guide Catheters (such as Merci® Balloon Guide Catheter and FlowGate® Balloon Guide Catheter) are recommended for use during thrombus removal procedures.
Retrievers are compatible with the Abbott Vascular DOC® Guide Wire Extension (REF 22260).
Retrievers are compatible with Boston Scientific RHV (Ref 421242).
SPECIFIC WARNINGS FOR INDICATION 1
WARNINGS APPLIED TO BOTH INDICATIONS
DOC is a trademark of Abbott Laboratories.
See package insert for complete indications, complications, warnings, and instructions for use. (Uploaded on October 21, 2016.)
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