4
Conclusions:
Results of the clinical study demonstrate that patients that have undergone diagnostic angiography and have received a 6F Angio-Seal Device can safely and effectively ambulate in less
than 20 minutes and be discharged one hour post ambulation.
HOW SUPPLIED
The Angio-Seal Evolution Vascular Closure Device is supplied sterile in a bag. This bag contains the following supplies.
1 each:
• 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 Device (refer to device component figure)
Device
Components
Device
Sleeve
Reference
Indicator
Suture Release
Button
Device Handle
Anchor
Suture
Device Handle
Device
Sleeve
Compaction
Tube
Hemostatic
Collagen
Sponge
Bypass
Tube
Suture Release
Button
Reference
Indicator
Carrier
Tube
ANGIO-SEAL DEVICE INSERTION PROCEDURE
The medical techniques and procedures described in these Instructions for Use do not represent ALL medically acceptable protocols, nor are they intended as a substitute for the
clinician’s experience and judgment in treating any speci
fi
c patient.
The Angio-Seal procedure is composed of three stages:
A. Locate the Artery
B. Set the Anchor
C. Seal the Puncture
A. Locate the Artery
1. Assess the puncture site location and evaluate the femoral artery characteristics prior to placing the Angio-Seal Device by injecting contrast medium through the procedure sheath
followed by an angiogram.
2. Using sterile technique, remove the Angio-Seal Device contents from the foil package, taking care to pull foil apart completely before removing the Angio-Seal Device.
NOTE: The Angio-Seal Device must be used within one hour after opening the foil pouch due to the moisture-sensitive nature of the product.
3. Insert the arteriotomy locator into the Angio-Seal insertion sheath (Figure 1), making sure the two pieces snap together securely. To ensure proper orientation of the arteriotomy
locator with the sheath, the hub of the locator and the sheath cap fit together only in the correct position. The reference indicator on the locator hub must align with the reference
indicator on the sheath cap.
Figure 1
Reference
Indicator
Insertion
Sheath
Cap
Drip Hole
Blood Inlet
Hole
Insertion
Sheath
Arteriotomy
Locator
1.5 cm
4. Insert the Angio-Seal guidewire into the procedure sheath that is currently in the patient. If the procedure sheath is smaller than the Angio-Seal sheath, it is advisable to ensure that
the skin incision is of sufficient size to accommodate the Angio-Seal insertion sheath.
5. Remove the procedure sheath, leaving the guidewire in place to maintain vascular access.
6. Thread the Angio-Seal arteriotomy locator/insertion sheath assembly over the guidewire; the drip hole (located above the arteriotomy locator hub) will be oriented down and away so
the flow of blood can be observed. Make sure the reference indicator on the insertion sheath is facing up, insert the assembly into the puncture tract. When the tip of the insertion
sheath is about 1.5 cm into the artery, blood will begin to flow from the drip hole in the locator (Figure 2).
