ANGIO-SEAL® (VIP Vascular Closure Device)

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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ANGIO-SEAL® (VIP Vascular Closure Device)

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PTCA Balloon Ryurei

Description

Confidence in your hands

Ryurei™ has superior crossability¹ thanks to the combination of low distal profiles and Terumo’s hydrophilic M coating. The short balloon bonding and reinforced shaft¹ results in enhanced trackability¹ while maintaining excellent pushability¹.

These features can increase physician’s confidence in success even during complex procedures.

Characteristics

Excellent Pusability

The combination of flexible distal part, tapered core wire on the midshaft and the thick proximal hypotube, results in smooth and balanced transition across the entire catheter for high transmission force, resulting in excellent pushability

Superior Crossability²

Thanks to the combination of distal low profiles and the Terumo hydrophilic M-Coat, Ryurei offers low friction in crossing tight lesions

Enhanced Trackability²

With an optimal tip design and improved balloon bonding, Ryurei provides enhanced trackability, even in tortuous anatomy and difficult to navigate vessels.

General specifications

Shaft diameter	1.9 Fr/0.64 mm Proximal • 2.5 Fr/0.84 mm Middle • 2.4 Fr/0.79 mm to 2.7 Fr/0.89 mm (tapered) Distal (1.00 to 1.50 mm) • 2.6 Fr/0.87 mm Distal (2.00 to 4.00 mm)
Usable length	145 cm
Balloon markers #	1(Ø1.0 to Ø 1.5 mm) • 2(Ø2.0 to Ø4.0 mm)
Nominal pressure	6 atm / 608 kPa
Rated burst pressure	Ø1.0 – 3.0 mm=14 atm(1419kPa) • Ø3.25 – 4.0 mm = 12 atm(1216 kPa)
Guidewire compatibility	Maximum diameter: 0.014″ / 0.36 mm
Lesion entry profile	0.41 mm (Ø1.00 to Ø1.50 mm) • 0.43 mm (Ø2.00 to Ø4.00 mm)
Coating	Hydrophilic

Balloon length / Product code
Balloon Diameter	5 mm	10 mm	15 mm	20 mm	30 mm	40 mm
1.00 mm	DC-RR1005HH
1.25 mm	DC-RR1205HH	DC-RR1210HH	DC-RR1215HH	DC-RR1220HH
1.50 mm	DC-RR1505HH	DC-RR1510HH	DC-RR1515HH	DC-RR1520HH
2.00 mm		DC-RR2010HHW	DC-RR2015HHW	DC-RR2020HHW	DC-RR2030HHW	DC-RR2040HHW
2.25 mm		DC-RR2210HHW	DC-RR2215HHW	DC-RR2220HHW
2.50 mm		DC-RR2510HHW	DC-RR2515HHW	DC-RR2520HHW	DC-RR2530HHW	DC-RR2540HHW
2.75 mm		DCRR2710HHW	DC-RR2715HHW	DC-RR2720HHW
3.00 mm		DC-RR3010HHW	DC-RR3015HHW	DC-RR3020HHW	DC-RR3030HHW	DC-RR3040HHW
3.25 mm		DC-RR3210HHW	DC-RR3215HHW	DC-RR3220HHW
3.50 mm		DC-RR3510HHW	DC-RR3515HHW	DC-RR3520HHW	DC-RR3530HHW	DC-RR3540HHW
3.75 mm		DC-RR3710HHW	DC-RR3715HHW	DC-RR3720HHW
4.00 mm		DC-RR4010HHW	DC-RR4015HHW	DC-RR4020HHW

References

¹ Ryurei φ1.00-5mm compared to Tazuna 1.25-10 mm- Data on file ISCD-416-31-4
* For Ryurei Ø 1.00 mm – Ø 1.50 mm.
** For Ryurei Ø 1.00mm – 5mm

² Compared to Tazuna PTCA dilatation catheter

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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?

ORDERING INFORMATION

BALLOON LENGTHS 6, 8, AND 12 MM

Balloon Diameter (mm)	Balloon Length (mm)
Balloon Diameter (mm)	6	8	12
2.00	NCEUP2006X	NCEUP2008X	NCEUP2012X
2.25	NCEUP22506X	NCEUP22508X	NCEUP22512X
2.50	NCEUP2506X	NCEUP2508X	NCEUP2512X
2.75	NCEUP27506X	NCEUP27508X	NCEUP27512X
3.00	NCEUP3006X	NCEUP3008X	NCEUP3012X
3.25	NCEUP32506X	NCEUP32508X	NCEUP32512X
3.50	NCEUP3506X	NCEUP3508X	NCEUP3512X
3.75	NCEUP37506X	NCEUP37508X	NCEUP37512X
4.00	NCEUP4006X	NCEUP4008X	NCEUP4012X
4.50	—	NCEUP4508X	NCEUP4512X
5.00	—	NCEUP5008X	NCEUP5012X

BALLOON LENGTHS 15, 20, AND 27 MM

Balloon Diameter (mm)	Balloon Length (mm)
Balloon Diameter (mm)	15	20	27
2.00	NCEUP2015X	NCEUP2020X	—
2.25	NCEUP22515X	NCEUP22520X	—
2.50	NCEUP2515X	NCEUP2520X	NCEUP2527X
2.75	NCEUP27515X	NCEUP27520X	NCEUP27527X
3.00	NCEUP3015X	NCEUP3020X	NCEUP3027X
3.25	NCEUP32515X	NCEUP32520X	NCEUP32527X
3.50	NCEUP3515X	NCEUP3520X	NCEUP3527X
3.75	NCEUP37515X	NCEUP37520X	NCEUP37527X
4.00	NCEUP4015X	NCEUP4020X	NCEUP4027X
4.50	NCEUP4515X	NCEUP4520X	—
5.00	NCEUP5015X	—	—

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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)

Orange and gray bar chart comparing deliverability of Resolute Onyx to Synergy XD and Xience Skypoint

Enhanced visibility with thinner struts

Platinum-iridium core within Resolute Onyx DES increases visibility for accurate stent placement without compromising strut thickness.²

Average visibility comparison²

(Higher is better)

Orange and gray bar chart comparing visibility of Resolute Onyx drug-eluting stent to Synergy, Xience, and Orsiro DES.

Cobalt alloy shell
Platinum iridium core

Close-up of the Resolute Onyx cobalt alloy shell and 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

Illustration of Resolute Onyx DES rounded struts

Square strut cross-section

SYNERGY™* DES
XIENCE™* DES

Illustration of square struts used by competitive coronary stents

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.

Columns

*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



*2.00*	*RONYX20008X*	*RONYX20012X*	*RONYX20015X*	*RONYX20018X*	*RONYX20022X*	*RONYX20026X*	*RONYX20030X*	*N/A*	*N/A*
*2.25*	*RONYX22508X*	*RONYX22512X*	*RONYX22515X*	*RONYX22518X*	*RONYX22522X*	*RONYX22526X*	*RONYX22530X*	*RONYX22534X*	*RONYX22538X*
*2.50*	*RONYX25008X*	*RONYX25012X*	*RONYX25015X*	*RONYX25018X*	*RONYX25022X*	*RONYX25026X*	*RONYX25030X*	*RONYX25034X*	*RONYX25038X*
*2.75*	*RONYX27508X*	*RONYX27512X*	*RONYX27515X*	*RONYX27518X*	*RONYX27522X*	*RONYX27526X*	*RONYX27530X*	*RONYX27534X*	*RONYX27538X*
*3.00*	*RONYX30008X*	*RONYX30012X*	*RONYX30015X*	*RONYX30018X*	*RONYX30022X*	*RONYX30026X*	*RONYX30030X*	*RONYX30034X*	*RONYX30038X*
*3.50*	*RONYX35008X*	*RONYX35012X*	*RONYX35015X*	*RONYX35015X*	*RONYX35022X*	*RONYX35026X*	*RONYX35030X*	*RONYX35034X*	*RONYX35038X*
*4.00*	*RONYX40008X*	*RONYX40012X*	*RONYX40015X*	*RONYX40018X*	*RONYX40022X*	*RONYX40026X*	*RONYX40030X*	*RONYX40034X*	*RONYX40038X*
*4.50*	*N/A*	*RONYX45012X*	*RONYX45015X*	*RONYX45018X*	*RONYX45022X*	*RONYX45026X*	*RONYX45030X*	*N/A*	*N/A*
*5.00*	*N/A*	*RONYX50012X*	*RONYX50015X*	*RONYX50018X*	*RONYX50022X*	*RONYX50026X*	*RONYX5*

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ANGIO-SEAL® (VIP Vascular Closure Device)

PRODUCT OVERVIEW

BIOABSORBABLE COMPONENTS

LOCATE THE ARTERY

SET THE ANCHOR

SEAL THE PUNCTURE

ANGIO-SEAL VIP PRODUCT CODES

REFERENCES

ANGIO-SEAL® (VIP Vascular Closure Device)

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Superior Crossability²

Enhanced Trackability²

Deliverability comparison — 3.0 mm DES²

Average visibility comparison²