SiteSeal SV

SiteSeal SV

More Comfort for Post-Surgical Endovascular Hemostasis

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.

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Open IFU
Substantial Equivalence Discussion
FDA Market Approval

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$55.00

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Value

Easier placement. Better Control. Optimal surface geometry.

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.

Research

More Comfort for Post-Endovascular Hemostasis

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.

  • Large base: length 2.5 inches, width 1.25 inches
  • North end incorporates an incline plane positioned above the arteriotomy site to control inflow blood pressure.
  • South end of the base positioned below the arteriotomy site controls back flow bleeding from collateral vessels.
  • Minimizes any margin of error in device placement.
  • There is a modulation effect from the spring.
  • Both the spring and elastic strap allow for ultimate tension flexibility in controlling blood flow.
  • Intuitive application by health care professional.