Leave Nothing Behind

Next generation vascular closure devices that simulate manual compression while removing associated variability. They absolutely leave nothing behind. Nothing within the vessel, vessel wall or any surrounding soft tissues. There is minimal patient discomfort, a minimal risk of complications, and lower costs. Ensite Vascular's devices can close any access site sheath, and multiple sheaths within a single vessel for EP procedures.

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Dr. Andrea Natale’s comments referable to the unique features of the SiteSeal closure device in closing multiple sheaths utilized during Electro Physiology (EP) procedures.

“I had the opportunity to evaluate a new EP closure device, SiteSeal, that closes multiple sheaths within a single vessel while leaving nothing behind in the vessel, vessel wall or surrounding soft tissues. I decided to do a comparison study between SiteSeal and the closure device I was presently utilizing. The comparison evaluated safety, efficacy, complications, patient comfort and cost. Fifty patients per each device were compared.

SiteSeal advantages:

    • Improved patient comfort. Immediate head elevation to 30 degrees with no restriction to leg movement.
    • Early ambulation. 30 minutes to one hour depending on sheath size.
    • Nothing left behind. No collagen plugs.
    • No significant complications.
    • Significant cost savings. One SiteSeal for multiple sheaths. One comparative device for each sheath.

Based on the evaluation of comparison study, I plan to use SiteSeal in my practice.”

-Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Institute, Austin Texas

Why

Exceptional Endovascular Physician Skills Deserve Better VCDs

When you excel at advanced endovascular techniques only to have patients’ outcomes and recovery affected by a VCD that leaves something behind, it’s time to make a change. SiteSeal is a simple-to-use, atraumatic, single VCD that establishes hemostasis with a minimal complication rate. Designed for use on patients of all shapes and sizes, SiteSeal closes the artery without leaving a foreign body behind or vascular alteration of the femoral artery. The SiteSeal SV is a VCD designed for the closure of small vessels of the extremities (Radial, Brachial, Pedal and Popliteal). The ideal VCDs you wish existed, now do.

Why

How

More Comfort for Post-Surgical Hemostasis

When post-endovascular surgery hemostasis from manual compression takes up a third of a professional’s time and introduces significant variability, it’s time for a new standard of care. SiteSeal is a VCD that can ambulate patients in approximately one hour for diagnostic procedures, and approximately two hours for interventional procedures unless modified by physician, while they lie more comfortably with their heads at a 30-degree angle and allows free leg movement. The SiteSeal SV's base design not only covers the access site but controls inflow of blood above the access site, as well as back flow bleeding from collaterals. VCDs that free up your hands and valuable time? They're here.

How

Value

Reduce Complication Risks

It's the closest thing to replacing manual compression without introducing variability. Gain significant overall cost reduction, and minimal complication risks for every endovascular procedure patient when your endovascular physicians use SiteSeal. That’s how it should be in today’s healthcare environment. Yet here you are, under pressure to control costs while improving patient outcomes with vascular closure standards of care that can be improved. SiteSeal establishes hemostasis in approximately an hour for diagnostic procedures, and approximately two hours for interventional procedures (unless modified by physician), doesn’t require manual compression, and leaves no foreign material behind so patients can be ambulatory and discharged safely. SiteSeal SV is simple to place and easily adjusts the inflow and outflow of blood, while minimizing patient discomfort and complications, but with no restrictions to extremity movement. The breakthrough VCDs are here.

Value

Research

By The Numbers

SiteSeal® and SiteSeal® SV™

  • Not limited by sheath size.
  • Allows immediate re-access.
  • Minimizes patient discomfort, allowing immediate head elevation to 30 degrees with no restriction to leg movement.
  • No patient limitation: size, anti-coagulation, calcification, etc.
  • Simple and rapid deployment.
  • Early ambulation.
  • Nothing left behind: the potential of minimal risk of vessel wall injury, infection, or embolization.

  • 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.

ADDITIONAL RESEARCH AND PUBLICATIONS ARE AVAILABLE HERE