FDA Approves Femoral Venous Closure Devices

The FDA has approved 2 medical devices for use in femoral vein closures following catheterization procedures. The Perclose ProGlide Suture-Mediated Closure system and the VASCADE Vascular Closure System have received expanded indication.

The ProGlide, manufactured by Abbott Vascular, delivers a single suture to close puncture sites (access sites) in the femoral vein or artery following a catheterization procedure. It was previously approved for use in access sites in the femoral artery using 5F to 21F sheaths. The expanded indication includes use in access sites in the femoral vein using 5F to 24F sheaths.

The device is able to close access sites ranging from about 0.07 to 0.32 inches in diameter. For larger puncture sites, created when catheters larger than about 0.1 inches in diameter are used, two ProGlide devices are necessary.

The device does not always eliminate the need for direct pressure, however. In 3 of 10 cases, pressure on the access site may be needed to completely stop blood flow. A retrospective analysis of a study using the of the Perclose ProGlide SMC device found that participants achieved hemostasis in a mean time of 5.15 minutes with less than 10 minutes of manual compression in addition to the ProGlide.

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