ANGIO-SEALTM VIP Vascular Closure Device

The Inside Advantage

Quickly and securely seal femoral artery punctures with the ANGIO-SEAL VIP vascular closure device. The V-Twist Integrated Platform (VIP) is a unique technology providing a larger collagen footprint for better arteriotomy coverage and enhanced conformability around the artery.

In both diagnostic and interventional cases, the ANGIO-SEAL VIP vascular closure device has been clinically proven to achieve earlier ambulation in patients.1

Image du DISPOSITIF DE FERMETURE VASCULAIRE ANGIO-SEAL® VIP

STEP-BY-STEP INSTRUCTIONS3

Angio-Seal inserted in an artery
Angio-Seal inserted in an artery

LOCATE THE ARTERY

  1. Exchange the procedure sheath with the Angio-Seal locator system
  2. Blood flow through the locator visually confirms proper sheath position in the artery
Angio-Seal anchor deployed in an artery
Angio-Seal anchor deployed in an artery

SET THE ANCHOR

  1. Insert the Angio-Seal VIP device into the sheath until you hear a “click.” 
  2. Gently pull back on the locking cap until you hear another “click.”
  3. The anchor is now locked in place and device is ready to be deployed.
Angio-Seal collagen plug deployed
Angio-Seal collagen plug deployed

SEAL THE PUNCTURE

  1. Gently pull back on the Angio-Seal VIP device until the suture has stopped spooling.
  2. Maintain upward tension on the device and gently advance the compaction tube until resistance is felt.
  3. Cut the suture and remove the device.

FREQUENTLY ASKED QUESTIONS

ANGIO-Seal MRI Safety - Is ANGIO-Seal MRI safe? 

The implanted components of the device are MRI Safe. The product is not made with natural rubber latex.8

Types of Vascular Closure Devices - What are some common types of vascular closure devices?

Percutaneous Closure Devices: These devices are inserted through a small incision in the skin and are guided to the puncture site to close the artery. They may use sutures, collagen plugs, or other mechanisms for closure.

Collagen Plugs or Sealants: Collagen-based plugs or sealants promote clot formation and provide a physical barrier to reduce bleeding, often used in combination with other closure methods.

Clip-Based Devices: These devices use clips or clamps to secure the arterial puncture site.

Vascular Compression Devices: These devices apply external pressure to the puncture site, aiding in hemostasis. They are commonly used alongside other closure devices.

ANGIO-SEAL VIP PRODUCT CODES

Part Number French Size Guidewire Diameter (in)
610132 6Fr .035 Wire
610133 8Fr .038 Wire

REFERENCES

  1. Martin JL, Pratsos A, Magargee E, Mayhew K, Pensyl C, Nunn M, Day F, Shapiro T. A randomized trial comparing compression, Perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: the CAP trial. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):1-5.
  2. Tellez A, Cheng Y, Yi GH, et al. In vivo intravascular ultrasound analysis of the absorption rate of the Angio-Seal™ vascular closure device in the porcine femoral artery. EuroIntervention. 2010;5(6):731-6.
  3. Angio-Seal VIP Instructions for Use. ASIN0015. 2023-05-09
  4. StarClose SE IFU EL2101551 (10/2/14)
  5. MYNX Control Vascular Closure Device IFU 07/21
  6. MYNXGRIP Vascular Closure Device IFU 04/20
  7. VASCADE Vascular Closure System IFU 2611 Rev T, 11 AUG 2021
  8. Perclose ProStyle Suture-Mediated Closure and Repair System IFU EL2127594 (2020-11-03)
  9. CELT ACD Vascular Closure Device IFU-TS-004 Rev 4 (SCR 230)

Indications:

The Angio-Seal Vascular Closure Device 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. Angio-Seal is 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 physicians with training qualifying them to perform arterial access and closure for endovascular procedures through the common femoral artery and have participated in a Terumo Medical Corporation Angio-Seal physician instruction program.

Exception (applicable to US and China only): 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. The advertisement is directed to physicians only, and not to consumers. Refer to product labels and packaging insert for complete warnings, precautions, potential complications, and instructions for use.

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