FDA Approval for Two Femoral Venous Closure Technologies

Article

The devices have received expanded indication for use in femoral vein closures in addition to previous approval for arterial closures.

Supawat Ratanapo, MD

Supawat Ratanapo, MD

The US Food and Drug Administration (FDA) has approved two 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.

VASCADE, produced by Cardiva Medical, was also already approved for use in arterial closures, however, it’s expanded indication is for smaller puncture sites of 5F to 7F.

The device inserting a collapsible mesh disk against the inside of the vessel wall to temporarily stop bleeding and then placing a thrombogenic bioabsorbable collagen patch, sealing the puncture. The patch is then absorbed into the body, leaving no permanent parts behind and allowing for future access to the vessel, if necessary.

A study led by Arun Nagabandi, MBBS, and colleagues, including Supawat Ratanapo, MD, showed that the Vascade device is safe and effective. Participants developed no hematomas, significant drops in hemoglobin requiring blood transfusion, access-site infections, or other complications.

Study authors wrote that Vascade was “shown to significantly decrease time to hemostasis, time to ambulation, time to discharge eligibility, and minor complication rate when compared with manual compression.”

“VASCADE has performed exceptionally well for our current patients, and this new indication will empower many physicians to use VASCADE for vein closure," said Joseph De Gregorio, MD, chief of invasive cardiology at Englewood Hospital and Medical Center in New Jersey. "Successful vessel closure and enabling a patient to walk as soon as possible after their procedure are critical factors for recovery from interventional procedures.

The study evaluating Vascade, “Use of Vascade Vascular Closure System for Venous Hemostasis,” was published in Vascular Disease Management. Results from the retrospective analysis of the ProGlide device are available in the FDA’s Summary of Safety and Effectiveness Data.

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