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Early clinical experience with the 6 French Angio‐Seal™ device: Immediate closure of femoral puncture sites after diagnostic and interventional coronary procedures

The objective of this study was to assess the early safety and efficacy of the novel 6 Fr Angio‐Seal device for routine clinical use after diagnostic cardiac catheterization and coronary angioplasty. In a prospective study, we used the 6 Fr Angio‐Seal™ device in 180 consecutive patients (131 male, 49 female, mean age 60.7 years) for closure of femoral arterial puncture sites immediately after diagnostic (n = 108) or interventional (n = 72) coronary procedures independent of the coagulation status. All patients were monitored for 24 hr after the procedure and followed for 30 days. The closure device was successfully deployed in 95.4% after diagnostic catheterization versus 98.6% after coronary angioplasty (P = 0.963). Immediate hemostasis was achieved in 91.5% versus 90.1% of the patients (P = 0.993). Major complications were observed 1.9% versus 2.8% of the patients (P = 0.885). During 30‐day follow‐up, no late events or complications were reported. The 6 Fr Angio‐Seal™ device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications. Cathet Cardiovasc Intervent 2001;53:437–442. © 2001 Wiley‐Liss, Inc.