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.
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RADIFOCUS INTRODUCER SHEATH
Radifocus™ Introducer II Standard Kit A
Introducer Sheath (FEMORAL)
Kit of vascular introducer with hemostatic valve with excellent blood tightness,
easy and non traumatic vessel insertion, patented valve design for a unique
features package.- Total Integrated Fit (TIF) tip tapering: tapering design at the tip of the sheath and dilator to facilitate smooth penetration
- Cross-cut hemostasis valve to avoid blood reflux and air aspiration
- Thin radiopaque sheath with anti-kinking sleeve for easy catheter handling
- Snap-on/click-off dilator lock prevents dilator back-out during insertion and allows one-hand unlocking
- Wide variety of kit variations providing all elements for quick vessel access: 4-11 Fr sheaths, 5-16 cm lengths, Surf lash needle
General specifications
Sheath length 10 cm Mini guidewire Plastic Straight and Angled
0.025″ (0.64 mm) for 4 Fr, straight mini guidewire type; 0.035″ (0.89 mm) for all others
45 cmEntry needle Plastic IV Catheter – 18G x 2 ½” (1.2 x 64 mm),
except for 4 Fr with 45 cm straight mini guidewire: 20G x 2″ (0.9 x 51 mm)
2.5 ml syringe is includedGuidewire compatibility 0.025″ (0.64 mm) for 4 Fr, straight mini guidewire type
0.035″ (0.89 mm) for all othersPackaging Tray A Kit content Sheath, dilator, plastic mini guidewire and plastic IV catheter (entry needle) Item specifications
Inner diameter Mini guidewire type 45 cm angled 45 cm straight 4 Fr RS+A40K10AQ RS+A40G10SQ 4 Fr RS*A40G10SQ RS*A40G05SQ 4 Fr RS*A40K10SQ RS*A40G07SQ 5 Fr RS*A50K10AQ RS*A50G07SQ 5 Fr RS+A50K10AQ RS+A50K10SQ 6 Fr RS+A60K10AQ RS+A60K10SQ 6 Fr RS*A60K10AQ RS*A60G07SQ 6 Fr — RS*A60G16SQZ 6 Fr — RS*A60K10SQ 6 Fr — RS+A50K10SQ 7 Fr — RS+A70K10SQ 7 Fr — RS*A70G07SQ 7 Fr — RS*A70K10SQ 8 Fr — RS+A80K10SQ 8 Fr — RS*A80K10SQ 9 Fr — RS*A90K10SQ 10 Fr — RS*A10K10SQ 11 Fr — RS*A11K10SQ A Kit includes: introducer sheath, dilator, mini Guide wire, entry venous catheter, 2.5 cc syringe
B Kit includes: introducer sheath, dilator, mini Guide wire
C Kit includes: introducer sheath, dilator
R Kit includes: introducer sheath, dilator, mini Guide wire, 18 G x 2 3/4” / 1.2 x 70 mm entry metallic needle
Other code numbers are available on special demand. For any further information, please contact your Terumo local representative
Units per box: 5 for kits in tray and 10 for kits in pouch. -
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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NC EUPHORA NONCOMPLIANT BALLOON CATHETER
NC Euphora™ noncompliant balloon
NC Euphora™ noncompliant balloon dilatation catheter combines Euphora technology with controlled, high-pressure performance.
Balloon Dilatation Catheter
OVERVIEW
From Collaboration to Innovation
When it comes to controlled, high-pressure performance, the NC Euphora™ noncompliant balloon dilatation catheter has what you’re looking for:
- High RBP up to 20 atm
- Low-growth profile1
- Superior deliverability1
In fact, we worked with nearly 2,000 interventional cardiologists and cath lab professionals to develop it — so you can choose it with confidence for your patients.
PRODUCT DETAILS
Looking for NC Euphora Noncompliant Performance?
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RESOLUTE INTEGRITY STENT
Resolute Onyx DES
for coronary artery disease
Resolute Onyx™ is a drug-eluting stent (DES) that’s different by design, optimised for complex PCI, and proven safe and effective in real-world, high bleeding risk patients on 1-month dual antiplatelet therapy (DAPT).1
Resolute Onyx DES is different by design to address your DES needs and a wide range of patient anatomies. It features:
- Best-in-class deliver ability
- Enhanced visibility with thinner struts
- Smooth side branch access
- Fast healing
- The broadest diameter range
Best-in-class deliverability
Single-wire design
Resolute Onyx DES is made from a single wire, which gives it a fluid range of motion and provides the flexibility needed for best-in-class deliverability.2
Sinusoid-formed wire
Helical wrap
Laser-fused
Competitive comparison
Resolute Onyx DES is more deliverable than laser-cut SYNERGY™* XD and XIENCE Skypoint™*, which are stiffer.
Deliverability comparison — 3.0 mm DES2
(Lower is better)
Enhanced visibility with thinner struts
Platinum-iridium core within Resolute Onyx DES increases visibility for accurate stent placement without compromising strut thickness.2Average visibility comparison2
(Higher is better)
- Cobalt alloy shell
- Platinum iridium core
Resolute Onyx cobalt alloy shell and platinum-iridum core
Smooth side branch access
Resolute Onyx DES has round struts to create a smooth passage when accessing the side branch and lower the propensity to catch during bifurcation procedures.2
Strut comparison
Rounded strut cross-section
- Resolute Onyx DES
Square strut cross-section
- SYNERGY™* DES
- XIENCE™* DES
Broadest diameter range
- Complex PCI requires a broad DES size matrix to match a wide range of patient anatomies.
- Resolute Onyx is the only DES with diameters ranging from 2.0 mm to 5.0 mm to treat a broad range of coronary vessel sizes.
Diameter (mm) Stent Length (mm) Maximum Expansion
Capabilities (MSID†) (mm)2.00 8 12 15 18 22 26 30 — — 3.50‡ 2.25 8 12 15 18 22 26 30 34 38 3.50‡ 2.50 8 12 15 18 22 26 30 34 38 3.50‡ 2.75 8 12 15 18 22 26 30 34 38 4.00‡ 3.00 8 12 15 18 22 26 30 34 38 4.00‡ 3.50 8 12 15 18 22 26 30 34 38 5.00‡ 4.00 8 12 15 18 22 26 30 34 38 5.00‡ 4.50 — 12 15 18 22 26 30 — — 6.00‡ 5.00 — 12 15 18 22 26 30 — — 6.00‡ PRODUCT DETAILS
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