SiteSeal SV is a simple-to-use, atraumatic, single VCD that establishes small-vessel hemostasis, all with a minimal complication rate. Designed for use on patients of all shapes and sizes, SiteSeal SV is the ideal small-vessel VCD.
Open IFU
Substantial Equivalence Discussion
FDA Market Approval
Ensite Vascular has received a second U.S. Food and Drug Administration (FDA) market clearance SiteSeal SV (small vessel) VCD to achieve hemostasis of the brachial artery after a transbrachial endovascular procedure.
SiteSeal SV is a new closure device designed for closure of small arterial vessels, specifically brachial, radial and pedal. It simulates external compression, but removes the associated variables, leaving nothing behind. SiteSeal SV applies invariant pressure to the vessel wall of the access site by utilizing an internal stainless steel spring, which functions as a shock absorber to dampen blood pressure fluctuation.
This design controls the inflow of blood above the arteriotomy site. This decreasing blood flow to the arteriotomy site allows the platelet aggregate to develop more quickly and gain more strength, offsetting potential breakdown that causes bleeding or hematoma formation when the device is removed.
The south end controls the potential for back flow bleeding from collateral vessels to the arteriotomy site. This too allows the platelet aggregate to develop more quickly and gain more strength. SiteSeal SV has a wide placement window because the high-pressure point is upstream of the arteriotomy and not at the site of the arteriotomy. This potentially eliminates the margin for error.
When a balloon is utilized as a closure device, the balloon, when inflated, has a limited surface area and has to be placed directly over the arteriotomy site. The actual puncture site of the artery is approximately 1.5 cm above where the skin is entered. This means the balloon has a very limited margin of error for placement. And, there is no control of blood inflow pressure above the arteriotomy site or collateral blood flow creating back pressure from below the arteriotomy site. Unlike the SV, which has a flat surface, a convex balloon surface provides a much more limited surface area that is in contact with the skin.
SiteSeal SV is a simple-to-use, atraumatic, single VCD that establishes small-vessel hemostasis, all with a minimal complication rate. Designed for use on patients of all shapes and sizes, SiteSeal SV is the ideal small-vessel VCD.
