Percutaneous Arterial Closure Devices

Some embodiments of the invention provide an apparatus for achieving hemostasis in a puncture tract that is created during a medical procedure. The puncture typically extends from the epidermis to the vasculature in a living organism. In some embodiments, the apparatus includes (1) a plug for subcutaneous placement within the puncture tract, and (2) a delivery mechanism for delivering and maintaining the plug within the puncture tract until hemostasis is achieved. The apparatus also includes in some embodiments a lubricious sheath that is placed around the plug to facilitate the insertion of the plug into the puncture tract.

Hemostatic wire guided bandage and method of use

Quality Improvement Guidelines for Vascular Access and Closure Device Use

Access site management with vascular closure devices for percutaneous transarterial procedures.

AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t-test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 +/- 4.36 vs. 18.59 +/- 11.77; P = 0.30) and ambulation (145.71 +/- 124 vs. 109.89 +/- 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 +/- 12.70 vs. 19.57 +/- 2.27; P = 0.077) and ambulation (607.32 +/- 344.22 vs. 486.48 +/- 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty.

Randomized comparison of Vasoseal and Angioseal closure devices in patients undergoing coronary angiography and angioplasty.

Femoral closure devices help early ambulation after cardiac catheterization without incurring additional risk to the patients. This report summarizes the safety and efficacy data of the 6Fr Angio-Seal device.

Lynn Oster

Papers

The 6Fr Angio-Seal arterial closure device: results from a multimember prospective registry.