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ANGIO-SEAL™ EVOLUTION™ VASCULAR CLOSURE DEVICE

CONTROLLED DEPLOYMENT FOR CONFIDENT CLOSURE

Failed closure is a leading predictor of vascular complications.1 You can achieve rapid, safe and reliable hemostasis with the Angio-Seal Evolution vascular closure device. Its standardized deployment system delivers consistent collagen compaction, designed to create an effective seal. 

The Angio-Seal Evolution vascular closure device has been clinically proven to:

  • Improve patient comfort1
  • Lower complication rates2


Click to learn more about Angio-Seal clinical evidence.

ACTIVE CLOSURE SYSTEM

Designed to hold the solution in place, the active closure system consists of an innovative intra-arterial anchor, suture and collagen seal that are fully bioabsorbable within 60 to 90 days.3

Image 1 Evolution
Bioabsorption-Graphic

DELIVERY COMPONENTS

We have designed the components of the Angio-Seal Evolution vascular closure device to create an effective seal.

Image 3 Evolution
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STEP-BY-STEP INSTRUCTIONS

Evo Step 1A
Evo Step 1B

LOCATE THE ARTERY5
Exchange procedure sheath with Angio-Seal locator system.

  1. Blood flow through the locator confirms sheath has entered the artery.
  2. Confirm proper location by withdrawing and reinserting the Angio-Seal locator system until blood flow resumes and then STOP.
  3. Remove locator and wire, leaving the sheath in place.
Evo Step 2A
Evo Step 2B

SET THE ANCHOR5

  1. Carefully grasp the Angio-Seal device just behind the bypass tube and slowly insert into the sheath until you hear a click.
  2. Maintain a grip on the sheath hub, grasp device handle, and gently pull back until you hear another click.
Evo Step 3A
Evo Step 3B

SEAL THE PUNCTURE5

  1. Provide support to the puncture site with two fingers.
  2. Gently pull back on the Angio-Seal device handle along the angle of the puncture tract.
  3. Continue to pull back until hemostasis is achieved. As a guide, the colored compaction marker will be revealed.
Evo Step 4A
Evo Step 4B

RELEASE THE SUTURE5

  1. Release and hold down the suture release button.
  2. Gently pull back on the device handle until the suture is exposed.
  3. With tension on the suture, cut the suture below skin level.

Angio-Seal Evolution

Part Number

French Size

Guidewire Diameter (in)

C610134 6Fr .035 Wire
C610135 8Fr .038 Wire

Angio-Seal Family of Products

Read more about the full Angio-Seal Product Portfolio.

REFERENCES

  1. Duffin, D. C., Muhlestein, J. B., Allisson, S. B., Horne, B. D., Fowles, R. E., Sorenson, S. G., … Lappe, D. L. (2001). Femoral arterial puncture management after percutaneous coronary procedures: A comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. Journal of Invasive Cardiology, 13(5), 354-362.
  2. Arora, N., Matheny, M. E., Sepke, C., & Resnic, F. S. (2007). A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. American Heart Journal, 153(4), 606-611.
  3. Nash, J. E., & Evans, D. G. (1999). The Angio-Seal hemostatic puncture closure device. Concept and experimental results. Herz, 24(8), 597-606.
  4. Tellez, A., Cheng, Y., Yi, G. H., Conditt, G. B., McGregor, J. C., Flynn, A. M., …Granada, J. F. (2010). In vivo intravascular ultrasound analysis of the absorption rate of the Angio-Seal vascular closure device in the porcine femoral artery. EuroIntervention, 5(6), 731-736. 
  5. Angio-Seal™ Evolution™ Instructions for Use.

Indications:
The  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 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 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.

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.

RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.