The largest prospective study of interventional treatment in high-risk PE
A total of 115 high-risk PE patients were enrolled and treated with either FlowTriever or other contemporary therapies.
>90% reduction in high-risk PE in-hospital all-cause mortality vs. other contemporary treatments in historical data.
† Composite primary endpoint consisted of in-hospital all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding.
¶ P<0.01 vs. performance goal based on historical data.
Source: Outcomes In High-risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy: Results From The FLAME Study presented at ACC March 2023 by Dr. Mitchell J. Silver
Indications for Use:
The FlowTriever Retrieval/Aspiration System is indicated for: (1) The non-surgical removal of emboli and thrombi from blood vessels, and (2) The injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever Catheters are also intended for use in treating clot in transit in the right atrium, but not in conjunction with FlowTriever catheters. The FlowTriever2 Catheter is indicated for: the non-surgical removal of emboli and thrombi from peripheral blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever2 Catheter is intended for use in the peripheral vasculature.
Caution: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician.
Refer to IFU for complete indications for use, contraindications, warnings, and precautions.
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