FemoSeal Evaluation Registry (FER). Prospective study of femoral arterial closure with a mechanical system on 100 patients who underwent angioplasty procedures

Safety and Efficacy of Femoral Artery Closure with the FemoSeal Device After Cerebral Thrombectomy Using an 8 French Sheath

“…In the present series, the device was successfully deployed in 98.9% of cases, which is superior to the results from the CLOSE UP study (93.6%) 6 and ISAR CLOSURE trial (94.7%), 8 which could be explained by the 4 years of experience using this device at the present centre. These results are equivalent to those published by De Poli et al 9 in their registry which included only 100 patients. Deployment failure is usually associated with an increased risk of large haematomas, 11 but, no major adverse events occurred in the present series.…”

“…This study showed that VCDs were not inferior to manual compression in terms of vascular access site complications and reduced the time to haemostasis. The study of De Poli et al 9 was a single centre prospective registry conducted from November 2010 to April 2011, comparing the results of manual compression (n ¼ 111 patients), haemostatic bandage compression (n ¼ 43 patients), and FemoSeal mechanical closure (n ¼ 100 patients). In the study, the use of FemoSeal was effective in achieving haemostasis performed through a femoral arterial approach up to 7F and was associated with a very low rate of complications (one haematoma).…”

Could real-time ultrasonography guidance be useful for the effective deployment of FemoSeal in common femoral arteriotomy?

“…The safety and feasibility of this VCD on retrograde femoral artery access have been investigated and verified in previous studies [1][2][3][4][5][6][7][8]. A recent article showed that the device could also be safely used even for anterograde femoral artery access [9].…”

“…A r t i c l e compression was followed when technical failure was brought out in many reviews [1][2][3][4]6,7]. Even though the remarkable event has not been found after following manual compression in some studies [4][5][6][7], large hematomas were found in 36% of technical failure cases according to one large-scale survey, CLOSE-UP study [2]. A clear description of the result of technical failure cannot be found in the ISAR-CLOSURE study, another large-scale study [1].…”

FemoSeal® vascular closure device for antegrade common femoral artery access: Safety and technical notes

“…The safety and efficacy of this device, compared or not with MC, have been documented in several papers, 5,[9][10][11] but its use in antegrade common femoral access has not been yet investigated, although St Jude Medical does not advise against it in its "Instruction for use. "…”