REDWOOD CITY, Calif., Nov. 8, 2010 /PRNewswire/ — Arstasis is
pleased to announce that patient enrollment has begun in the
RECITAL (A Patient Registry Evaluating Closure Following Access
with the Arstasis One Access System) Study. The
non-randomized, prospective, post-approval study is anticipated to
enroll up to 500 patients in at least seven U.S. hospitals.
The goal of the study is to observe the clinical safety and
effectiveness of the Arstasis One Access System in patients
undergoing diagnostic angiography procedures through the femoral
artery.
The first patient was enrolled at La Paz Regional Medical Center
in Parker, Arizona. “We’ve begun performing Arstaotomy
procedures routinely in our cath lab because they make femoral
artery access safer for our patients, easier for me and my staff,
and less expensive for our hospital compared with closure devices
or manual compression,” said Dr. Frank Kresock, chief of
interventional cardiology at La Paz Regional Medical Center, the
physician who performed the procedure.
Since 1959, physicians have been using the Modified Seldinger
Technique (or “Seldinger Technique” for short) 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, 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
get to stop bleeding. With the Arstasis One Access System,
however, physicians may 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procedure, when the sheath is withdrawn, the shallow-angle pathway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
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