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Arstasis One Femoral
Artery Access System
The US Food and Drug Administration recently granted
United States marketing clearance to the Arstasis One
femoral artery access system (Arstasis, Inc., San Carlos,
CA). According to the company, the device allows
physicians performing angiographic procedures
to create a shallow-angled needle pathway
through the wall of the femoral artery for
placement of an introducer sheath. At the
end of the procedure, when the sheath is
withdrawn, the shallow-angled pathway collapses from the normal pressure
of the patient's femoral artery blood flow from below and approximately
4 minutes of mild, nonocclusive pressure from above, resulting in
quick cessation of bleeding and a positive experience for the clinician
and patient alike. According to the company's Web site, “The resulting
closed access site provides vascular closure device–like profiles in time
to hemostasis and time to ambulation in diagnostic patients.”
Quick-Close Vascular
Closure Device
Quick-Close (Interventional Therapies, Westport, CT) is a vascular
closure device that received US Food and Drug Administration premarket
approval in April 2010. The product previously received CE Mark
approval in Europe. Quick-Close is approved for use in femoral arteriotomy
closure in both diagnostic and interventional endovascular procedures
using 5- to 8-F sheaths. According to the company, Quick-Close is designed
to allow for simple, verifiable, and consistently safe vascular closure. The
device enables the user to significantly reduce time to hemostasis and time
to ambulation with the additional safety of verifiable suture closure.
In the pivotal trial involving 367 patients, the median time to hemostasis was 1 minute. Quick-Close has no intraluminal moving parts, thereby reducing the potential for occlusion or other device-related complications. In addition, the device has been engineered to allow the user to have a safety check at each step to ensure proper percutaneous placement and function.
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