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The Gelbfish Endo-Vac System is intended for the percutaneous aspiration of thrombus from acutely clotted AV grafts as a part of a percutaneous thrombectomy procedure. The device incorporates an anti-clogging/selfcleaning mechanism to maintain its uninterrupted function. The device is not (by itself) intended to restore function to clotted AV grafts. It is only used in conjunction with standard percutaneous thrombectomy procedures to facilitate the aspiration of clot from the graft. The arterial and venous anastomotic plug/clot and pathology must still be addressed by standard Fogarty and/or balloon catheter procedures. Expertise in traditional pharmoco-mechanical techniques is necessary, and may be used in conjunction with the Endo-Vac System. The enclosed device is indicated for use to remove thrombus in clotted synthetic ePTFE grafts only. Its short length makes it suitable for aspiration of clot from the "body" of the graft. It is NOT intended to cross arterial or venous anastomoses or to be used on clot contained in native artery or vein.

The Gelbfish EndoVac System consists of a set of three main groups of components: (1) an introducer sheath with side-port for suction connection (with three-way stopcock), plus dilator and guidewire (used for initial sheath insertion), (2) a stainless steel anti-clogging/self-cleaning unit with connector for saline injection, dual check valve, tubing and syringe for saline irrigation, and (3) suction components--a fail-safe trumpet suction valve, and suction tubing. All but the stainless part are components that are presently marketed as medical devices or components. Only the stainless steel self-cleaning unit is new, and it is fabricated from medical grade stainless steel components used for blood contact applications.