Arstasis One Access Device Launched in United States

January 4, 2011—Arstasis, Inc. (Redwood City, CA) announced the nationwide launch of the Arstasis One femoral artery access device in the United States. The disposable device allows interventionists to perform angiography without inserting a vascular closure implant into the patient.


According to the company, the Arstasis One access device creates a shallow-angle needle pathway through the wall of the femoral artery. At the end of the procedure, when the sheath is withdrawn, the shallow-angle pathway collapses from the normal pressure of the patient's femoral artery blood flow from below and approximately 3 to 4 minutes of mild, nonocclusive finger-pressure from above, resulting in a quickly sealing access site. By contrast, the standard modified Seldinger technique results in a substantial hole in the patient's femoral artery that typically takes significant effort and catheterization laboratory resources to close.

Along with the launch in the United States, patient enrollment is continuing in the RECITAL (A Patient Registry Evaluating Closure Following Access With the Arstasis One Access Device) study, a nonrandomized, prospective, postmarket registry that is anticipated to enroll up to 500 patients in at least seven hospitals, the company stated.