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Instructions for Use
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The Angio-Seal vascular closure device quickly seals femoral artery punctures following catheterization procedures, allowing for early ambulation and hospital discharge. The device creates a mechanical seal by sealing the arteriotomy between a bio-absorbable anchor and collagen sponge, which dissolve within 60 to 90 days. The VIP (V-Twist Integrated Platform) is a unique technology providing a larger collagen footprint for better arteriotomy coverage and designed for enhanced conformability around the artery for a more uniform and secure seal.
The Angio-Seal Vascular Closure Device uses three bioabsorbable components to actively seal the arteriotomy:
All components are fully absorbed within 60-90 days.
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Contents: Vascular Closure Device, Insertion Sheath, Arteriotomy Locator and 70 cm Guidewire with “J” Straightener (10 units per box)
Proven to provide confident closure in both diagnostic and interventional cases, the Angio-Seal™ VIP Vascular Closure Device is the device of choice for closure in even the most challenging situations. Watch this demonstration to understand how Angio-Seal VIP provides enhanced conformability around the artery for a more uniform and secure seal.
Watch the video to the right and then scroll down to see Step-by-Step Instructions on the use of the Angio-Seal VIP Vascular Closure Device.
Video presented without sound.
Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
St. Jude Medical Angio-Seal™ Vascular Closure Device product family, including the STS Plus, VIP and Evolution platforms, is indicated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8F Angio-Seal™ device and a 6 French or smaller procedural sheath for the 6 F Angio-Seal™ device. The Angio-Seal™ STS Plus, VIP and Evolution platform devices are also indicated for use to allow patients who have undergone diagnostic angiography to safely ambulate as soon as possible after sheath removal and device placement, as well as to allow patients who have undergone an interventional procedure to safely ambulate after sheath removal and device placement. Possible adverse events for vascular closure devices include, but are not limited to: bleeding or hematoma, AV fistula or pseudoaneurysm, infection, allergic reaction, foreign body reaction, inflammation, or edema.