First Patient Enrolled in Femoral Access/Closure Device Study


November 8, 2010

November 8, 2010 – Patient enrollment has begun in a trial looking at a new system for patients undergoing diagnostic angiography procedures through the femoral artery. The RECITAL study will observe the safety and effectiveness of the Arstasis One access system. It is expected 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 a patient’s femoral artery. At the end of every such case, each patient is left with a substantial hole in his/her femoral artery, which typically takes significant effort and cath lab resources to get to stop bleeding.

Using the Arstasis One access system, physicians may create a shallow-angle needle pathway through the wall of the femoral artery. At the end of the procedure, all that is needed is approximately three to four minutes of mild, nonocclusive finger-pressure. That – combined with the patient’s femoral artery blood flow – helps collapse the shallow-angle pathway and quickly seal the site.

"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 Frank Kresock, M.D., chief of interventional cardiology at La Paz Regional Medical Center in Parker, Ariz. The trial’s first patient was enrolled at the center and Kresock performed the procedure.

"The Arstasis One femoral artery access system marks the beginning of a new approach to heart catheterization," said Zoltan G. Turi, M.D., director of the vascular center at Cooper University Hospital and the national principal investigator of the study. "We hope to show that patients who participate in this study benefit from femoral artery closure that has advantages over regular manual compression. We are also interested in this technology because Arstasis-facilitated closure, unlike vascular closure devices, does not result in any foreign materials being implanted."

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