Arstasis One Device Now Available in United States

Arstasis out of Redwood City, CA, having received FDA 510(k) clearance for its Arstasis One last May, is finally releasing the low angle femoral artery access device to the U.S. market. The idea is to improve healing and possibly decrease the number of femoral hematomas post puncture thanks to an increased tissue overlap when entering at a shallower angle.

Since 1959, physicians have been using the Modified Seldinger Technique to insert flexible catheters into the femoral artery of patients for the purpose of performing procedures in the patient’s arterial-vascular system. The most prevalent such procedure, diagnostic angiography, is thought to be performed more than half a million times per month worldwide. At the end of every such case, each patient is left with a substantial hole in his/her femoral artery (upper inner thigh) which typically takes significant effort and cath lab resources to close. With the Arstasis One Access Device, however, physicians create 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 At the end of the procedure, when the sheath is withdrawn, the shallow-angle pathway collapses from the normal pressure of the patient’s femoral artery blood flow from below and approximately 3-4 minutes of mild, non-occlusive finger-pressure from above, resulting in a quickly sealing access site.