REDWOOD CITY, Calif., Jan. 4, 2011 /PRNewswire/ — Arstasis is
pleased to announce the Arstasis One Access Device is available to
physicians, nurses, patients, and cath lab technicians across the
United States. Until now, only a select number of physicians
participating in Arstasis clinical trials and select pre-launch
registries have been able to use the device. As of today, the
company is making the simple-to-use, disposable tool that allows
physicians to perform the Arstaotomy procedure available to any
qualified U.S. hospital with an accredited cardiac catheterization
laboratory.
“We are delighted to begin providing U.S. cardiologists with a
femoral artery access device that allows them to perform
angiography without resorting to inserting a vascular closure
implant into the patient,” said Bruce Modesitt, CEO of
Arstasis.
Along with the U.S. launch, patient enrollment is continuing in
the RECITAL (A Patient Registry Evaluating Closure Following Access
with the Arstasis One Access Device) study, a non-randomized,
prospective, post-market registry anticipated to enroll up to 500
patients in at least seven U.S. hospitals.
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withdrawn, the shallow-angle pathway collapses from the norm
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