News | November 08, 2010

First Patient Enrolled in Femoral Access/Closure Device Study

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."

For more information:

Related Content

Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
New Study Focuses on Protein Responsible For Increased Heart Disease Risk
News | Cardiac Diagnostics| August 03, 2017
August 3, 2017 — A study to reduce the strongest inherited...
Overlay Init