ANGIO-SEAL® (VIP Vascular Closure Device)
PRODUCT OVERVIEW
BIOABSORBABLE COMPONENTS
The device creates a mechanical seal by sandwiching the arteriotomy between a bioabsorbable anchor and collagen sponge, which dissolve in 60 to 90 days.
Three bioabsorbable components actively seal the arteriotomy:
- Anchor: Bioabsorbable co-polymer anchor placed against the inside of the vessel wall
- Collagen: Placed on top of the arteriotomy in the tissue tract
- Suture: Cinches the anchor and collagen together to form a secure seal.
LOCATE THE ARTERY
- Exchange the procedure sheath with the Angio-Seal locator system.
- Blood flow through the locator visually confirms proper sheath position in the artery.
SET THE ANCHOR
- Insert the Angio-Seal VIP device into the sheath until you hear a “click.”
- Gently pull back on the locking cap until you hear another “click.”
- The anchor is now locked in place and device is ready to be deployed.
SEAL THE PUNCTURE
- Gently pull back on the Angio-Seal VIP device until the suture has stopped spooling.
- Maintain upward tension on the device and gently advance the compaction tube until resistance is felt.
- Cut the suture and remove the device.
ANGIO-SEAL VIP PRODUCT CODES
| Part Number | French Size | Guidewire Diameter (in) |
| 610130 | 6Fr | .035 Wire |
| 610131 | 8Fr | .038 Wire |
REFERENCES
RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.
- Nash JE, Evans DG. (1999). The Angio‐Seal hemostatic puncture closure device. Concept and experimental results. Herz, 24(8), 597‐606.
- Per Instructions For Use ASIN0004 revision 2018-09-01.
Indications:
The Angio-Seal Vascular Closure Device product family, including the VIP and Evolution platforms, is indicated for use in closing and reducing time to hemostasis of 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 8 F Angio-Seal device and a 6 French or smaller procedural sheath for the 6 F Angio-Seal device. The Angio-Seal 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.
Important Safety Information:
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. This device should only be used by a licensed physician (or other health care professional authorized by or under the direction of such physician) possessing adequate instruction in the use of the device, e.g., participation in an Angio-Seal physician instruction program or equivalent.
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