Description

Simple.Proven. Fast Sealing.

Angio-seal is a medical device 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 (minimal artery diameter of 4mm).  

The 6F Angio-Seal device is for closure after usage of a 6 French or smaller procedural sheath, while the 8F Angio-Seal device is for closure after usage of an 8 French or smaller procedural sheath.  

Characteristics

-Insertion Sheath

-Arteriotomy Locator

-6F (2.0 mm) – 0.035 in. (0.89 mm) Guidewire with J-Straightener or 8F (2.7 mm) – 0.038 in. (0.96 mm) Guidewire with J-Straightener

-Angio-Seal consists of 3 bioabsorbable components: anchor, collagen, and suture

-10 units per box

-Single use, one year shelf life after sterilization

-Sterilized by gamma radiation. Do not re-sterilize

-Available in select markets

Storage, packaging and disposal:

-Should be stored in a cool location (between 15°C and 25 °C)

-Contains resorbable materials that degrade by exposure to heat and moisture; therefore, the device may not be resterilized

-Sterile and non-pyrogenic in unopened and undamaged package

-Dispose of contaminated units, components, and packaging materials utilizing standard hospital procedures and universal precautions for biohazardous waste.

Procedure

Step by step instructions

1. Locate the artery

-​Insert the Angio-Seal locator and sheath system over the wire until blood flows through the drip hole in the locator

-Withdraw and re-insert to confirm correct location into the vessel

-Remove the locator and wire, leaving the Angio-Seal sheath in place

2. Set the anchor

-​​Insert the Angio-Seal device into the sheath, click into place and click back to deploy and set the anchor

3. Set the seal

-Pullback the device/sheath assembly until the suture stops

-Grasp the tamper tube to manually compact until reaching the black compaction marker

-Confirm hemostasis and cut the suture

General specifications