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.
Related products
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Coronary Diagnostic Catheter (OPTITORQUE)
PRODUCT OVERVIEW
A complete line of coronary diagnostic catheters designed for superior torque control and precise placement.
RADIAL-SPECIFIC UNIVERSAL SHAPES
- Radial Specific curves designed to enable support and alignment during catheterization1
- Excellent back-up support for angiography of both RCA and LCA with a single catheter1,a
- Universal design eliminates the need for catheter exchanges and potentially shortens procedural and fluoroscopic time
1. DOF Reference
a. when compared to leading competitors
2. Ikaria article.OPTITORQUE Classic Shapes
Shape Category Product Code
5 Fr / 1.70 mmProduct Code
6 Fr / 2.00 mmShape Name (cm) Length Holes Side Tip Shape Pigtail 40-5030 40-6030 Straight Pigtail 110 6 40-5031 40-6031 Angled Pigtail 155° 110 6 Judkins Left 40-5040 40-6040 JL 3.5 (Judkins Left 3.5 cm) 100 40-5041 40-6041 JL 4.0 (Judkins Left 4.0 cm) 100 40-5042 40-6042 JL 5.0 (Judkins Left 5.0 cm) 100 Judkins Right 40-5043 40-6043 JR 3.5 (Judkins Right 3.5 cm) 100 40-5044 40-6044 JR 4.0 (Judkins Right 4.0 cm) 100 40-5045 JR 5.0 (Judkins Right 5.0 cm) 100 Bypass 40-5050 40-6050 Internal Mammary 100 Amplatz 40-5060 AL 1 (Amplatz Left Small Type) 100 40-5061 40-6061 AL 2 (Amplatz Left Middle Type) 100 UNIQUE DESIGN
- Designed for coaxial alignment to the ostium, allowing the catheter to sit at the appropriate angle for optimal engagement
- Large lumen allows high flow of contrast media and allows downsizing of French size
PROVEN PERFORMANCE
- Superior torqueability for precise placement1,a
- Excellent trackability in tortuous anatomy while navigating the radial artery1,a
- Superior flow rates for diagnostic imaging1,a
1.DOF
a. When compared to leading competitors -
GUIDING CATHETER EKARI
Product Overview
IMPROVED BACK UP SUPPORT*1
Catheter designed to use contralateral wall resulting in enhanced back-up support.
UNIVERSAL SHAPE (IKARI LEFT) *2
Offer capability of accessing the right and left coronary arteries, potentially avoiding catheter exchanges.
DESIGN FOR SAFETY
Soft tip to reduce damage to the vessel wall
*1: Ikari Y, Nagaoka M, Kim JY, Merino Y, Tanabe T. The physics of guiding catheters for the left coronary artery in transfemoral and trans-radial interventions. J Invasive Cardio. 2005 Dec; 17(12): 636-641.*2: Youssef AA, Hsieh YK, Cheng CI, We CJ. A single trans-radial guiding catheter for right and left coronary angiography and intervention. Euro intervention 2007; 3: 475-481.
Patients who have had cardiac catheterization or coronary angioplasty often are required to stay in bed with restricted movement for three to 24 hours afterward to prevent bleeding from the femoral artery catheter insertion site.
Features and Benefits
Improved back up support in comparison to Terumo standard femoral guiding catheter shapes*1
*1: Based on comparative studies made among Terumo Guiding Catheters*2: Ekari Y, Nagaoka M, Kim JY, Merino Y, Tanabe T. The physics of guiding catheters for the left coronary artery in transfemoral and trans-radial interventions. J Invasive Cardio. 2005 Dec; 17(12): 636-641.*3: Youssef AA, Hsieh YK, Cheng CI, We CJ. A single trans-radial guiding catheter for right and left coronary angiography and intervention. Euro intervention 2007; 3: 475-481.
Guide catheters are required for all coronary interventions to provide access to the coronary ostium and support equipment delivery. The ideal guide provides stability for device advancement through the coronary anatomy, while minimizing vessel trauma and allowing for vessel opacification.
The catheter is guided to the narrowed artery. Then, a smaller balloon catheter is inserted through the flexible catheter and inflated at the narrowed area to open it. Often, the doctor will also place a mesh coil called a stent at the narrowed part to help keep the artery open.
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Launcher- 6f Guiding Catheter’s
EBU@ (Extra Backup)
LA6EBU30 (EBU 3.0)
LA6EBU35 (EBU 3.5)
LA6EBU375 (EBU 3.75)
LA6EBU40 (EBU 4.0)
LA6EBU45 (EBU 4.5)
LA6EBU50 (EBU 5.0)
JL@ (Judkin Left )
LA6JL30 (JL 3.0)
LA6JL35 (JL 3.5)
LA6JL40 (JL 4.0)
LA6JL45 (JL 4.5)
LA6JL50 (JL 5.0)
LA6JL60 (JL 6.0)
JR@ (Judkin Right )
LA6JR30 (JR 3.0)
LA6JR35 (JR 3.5)
LA6JR40 (JR 4.0)
LA6JR45 (JR 4.5)
LA6JR50 (JR 5.0)
LA6JR60 (JR 6.0)
AL@ (Amplatz Left )
LA6AL75 (AL .75)
LA6AL10 (AL 1.0)
LA6AL15 (AL 1.5)
LA6AL20 (AL 2.0)
LA6AL25 (AL 2.5)
LA6AL30 (AL 3.0)
LA6AL40 (AL 4.0)
SAL@ (Short Amplatz Left)
LA6SAL75 (SAL . 75)
LA6SAL10 (SAL 1.0)
LA6SAL15 (SAL 1.5)
LA6SAL20 (SAL 2.0)
LA6SAL25 (SAL 2.5)
LA6SAL30 (SAL 3.0)
LA6SAL40 (SAL 4.0)
AR@ (Amplatz Right)
LA6AR10 (AR 1.0)
LA6AR20 (AR 2.0)
LA6ALR12 (ALR 1.2)
ECR Curves@ (Backup Support Right)
LA6ECR35 (ECR 3.5)
LA6ECR40 (ECR 4.0)
LA6ECR45 (ECR 4.5)
LA6RBU35 (RBU 3.5)
LA6RBU40 (RBU 4.0)
SCR@ (Shepherd’s Crook Right)
LA6SCR35 (SCR 3.5)
LA6SCR40 (SCR 4.0)
LA6SCR50 (SCR 5.0)
SAR@ (Short Amplatz Right)
LA6SAR10 (SAR 1.0)
LA6SAR20 (SAR 2.0)
Multipurpose@
LA6MB1 (MB 1)
LA6MB2 (MB 2)
LA6HSREL (Hockey Stick)
LA6HSI (Hockey I)
LA6HSII (Hockey II)
LA6HSIII (Hockey III)
Bypass Crafts@
LA6LCB (LCB)
LA6RCB (RCB)
LA6RCB (RCB III)
LA6RCB (RCB 90cm)
LA6IMA (IMA)
LA6IMA (IMA 90cm)
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Launcher- 7f Guiding Catheter’s
EBU@ (Extra Backup)
LA7EBU30 (EBU 3.0)
LA7EBU35 (EBU 3.5)
LA7EBU375 (EBU 3.75)
LA7EBU40 (EBU 4.0)
LA7EBU45 (EBU 4.5)
LA7EBU50 (EBU 5.0)
JL@ (Judkin Left )
LA7JL30 (JL 3.0)
LA7JL35 (JL 3.5)
LA7JL40 (JL 4.0)
LA7JL45 (JL 4.5)
LA7JL50 (JL 5.0)
LA7JL60 (JL 6.0)
JR@ (Judkin Right )
LA7JR30 (JR 3.0)
LA7JR35 (JR 3.5)
LA7JR40 (JR 4.0)
LA7JR45 (JR 4.5)
LA7JR50 (JR 5.0)
LA7JR60 (JR 6.0)
AL@ (Amplatz Left )
LA7AL75 (AL .75)
LA7AL10 (AL 1.0)
LA7AL15 (AL 1.5)
LA7AL20 (AL 2.0)
LA7AL25 (AL 2.5)
LA7AL30 (AL 3.0)
LA7AL40 (AL 4.0)
SAL@ (Short Amplatz Left)
LA7SAL75 (SAL . 75)
LA7SAL10 (SAL 1.0)
LA7SAL15 (SAL 1.5)
LA7SAL20 (SAL 2.0)
LA7SAL25 (SAL 2.5)
LA7SAL30 (SAL 3.0)
LA7SAL40 (SAL 4.0)
AR@ (Amplatz Right)
LA7AR10 (AR 1.0)
LA7AR20 (AR 2.0)
LA7ALR12 (ALR 1.2)
ECR Curves@ (Backup Support Right)
LA7ECR35 (ECR 3.5)
LA7ECR40 (ECR 4.0)
LA7ECR45 (ECR 4.5)
LA7RBU35 (RBU 3.5)
LA7RBU40 (RBU 4.0)
SCR@ (Shepherd’s Crook Right)
LA7SCR35 (SCR 3.5)
LA7SCR40 (SCR 4.0)
LA7SCR50 (SCR 5.0)
SAR@ (Short Amplatz Right)
LA7SAR10 (SAR 1.0)
LA7SAR20 (SAR 2.0)
Multipurpose@
LA7MB1 (MB 1)
LA7MB2 (MB 2)
LA7HSREL (Hockey Stick)
LA7HSI (Hockey I)
LA7HSII (Hockey II)
LA7HSIII (Hockey III)
Bypass Crafts@
LA7LCB (LCB)
LA7RCB (RCB)
LA7RCB (RCB III)
LA7RCB (RCB 90cm)
LA7IMA (IMA)
LA7IMA (IMA 90cm)
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