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The F.A.S.T.™ System SED and CXD are indicated for: - The non-surgical removal of emboli and thrombi from blood vessels. - The non-surgical removal of thrombi from synthetic grafts. - Temporary use in vessel/graft occlusions. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft. - Catheter placement over a guidewire.

The F.A.S.T.™ System - SED (Self-Expanding Device) and F.A.S.T.™ System - CXD (Controlled Expansion Device) are sterile, disposable, thrombectomy systems for the non-surgical removal of emboli and thrombi from blood vessels or grafts. The F.A.S.T.™ System -- SED consists of a self-expanding nitinol basket mounted on a core wire. The device is compressed and sheathed in an introducer designed to facilitate loading and advancement of the device into the proximal hub of an 0.021-in (0.533-mm) microcatheter. When advanced to the distal end of a microcatheter, the compressed basket is deployed by withdrawing the microcatheter over the basket may be reconstrained back into the microcatheter. The F.A.S.T.™ System - CXD Device consists of an expandable nitinol basket mounted on a hollow tube and core wire. Basket expansion and contraction to the desired diameter is controlled by the operator at the proximal end of the device. Using the handle control, the basket is contracted prior to withdrawing the device back into the microcatheter. Both the F.A.S.T.™ System - SED and the F.A.S.T.TM System - CXD have markers at the proximal and distal ends of the basket to facilitate visualization under fluoroscopy and are compatible with 0.021 inch (0.533-mm) inner diameter (ID) microcatheters.

The Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/ Suction Thrombectomy) System is indicated for: - The non-surgical removal of emboli and thrombi from blood vessels. . - . The non-surgical removal of thrombi from synthetic grafts. - . Use in temporary blood vessel/graft occlusion. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a ● vessel/graft. - . Catheter placement over a guidewire.

The Genesis Medical Interventional™ F.A.S.T.TM (Facilitated Aspiration/Suction Thrombectomy) System is comprised of the following main components: - Expanding Basket Thrombectomy Guidewire; . - Funnel Sheath Catheter; . - Dilator: - . Funnel Sheath Catheter/Dilator assembly Tip Cover - Accessories 18 gauge needle and vacuum syringe. .