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 At the end of the procedure, when the sheath is withdrawn, the shallow-angle pathway collapses from the normal pressure of the patient's femoral artery blood flow from below