MynxGrip® vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access...

Evaluate the safety of MynxGrip® for common femoral vein closure.

This is a multicenter, randomized, prospective study of 208 patients who were slated to undergo diagnostic/interventional procedures via femoral venous access. Patients were randomized 1:1 to receive venous hemostasis via MynxGrip® (n = 104) or manual compression (n = 104) utilizing 5, 6, and 7 Fr sheaths. Bilateral calf and thigh circumferences were measured serially. Patients were followed up through hospital discharge. There were no differences in the baseline characteristics between the two groups.

There was no difference between the groups for venous thrombosis, (0%, p = 1). Overall, there was no significant change in access site calf (-0.18 ± 1.38 cm, p = 0.18) or thigh diameter (0.33 ± 2.86, p = 0.81). In both groups, none of the patients had major or minor vascular complications, access site infection, nerve injury, or access site bleeding requiring transfusion. The pre- to post-procedure hemoglobin drop was -0.51 ± 1.1 vs. -0.64 ± 1.3 g/dL, p = 0.59 in the manual compression group and MynxGrip® group, respectively. Time to hemostasis, was significantly lower in the MynxGrip® group compared to the manual compression group with 0.12 ± 0.89 vs. 7.6 ± 5.7 min, respectively (p < 0.001).

The MynxGrip® extravascular sealant is safe and effective for femoral venous access site closure.