PRODUCT PORTFOLIO

AaRiss™

A paclitaxel drug-coated balloon catheter using PurePac™ coating technology for targeted vascular drug delivery.

AaRiss™ product features and medical device

CLINICAL POSITIONING

Drug-coated balloon technology.

AaRiss™ combines a non-excipient paclitaxel coating with a balloon-catheter delivery platform. PurePac™ coating technology is designed to limit drug loss during tracking and inflation, support rapid transfer to the vessel wall, and provide a sustained therapeutic effect.

Product availability and regulatory status vary by market. Information presented here is a portfolio overview and not medical advice or instructions for use.

COATING TECHNOLOGY

Optimized coating formulation

The PurePac™ coating technology provides an optimal delivery mechanism, ensuring minimal drug loss during tracking and inflation, rapid drug transfer to the vessel wall and a sustained therapeutic effect.

Drug
Paclitaxel anti-proliferative agent
Dose
Coronary artery stenosis (3 μg/mm²) and intracranial artery stenosis (2 μg/mm²)
Coating
Pure paclitaxel, non-excipient design
Layers
Composite coating, 70% crystalline and 30% amorphous

Safe and effective

AaRiss™ drug-coated balloon catheter has undergone clinical trials for in-stent restenosis of coronary arteries, coronary bifurcation lesions, and intracranial atherosclerotic stenotic lesions, which have proven to inhibit restenosis while maintaining a high safety profile.

PRODUCT INFORMATION

Compliance Data

Balloon Diameter (mm)Pressure
608 kPa (6 atm)811 kPa (8 atm)1013 kPa (10 atm)1216 kPa (12 atm)1419 kPa (14 atm)1621 kPa (16 atm)
2.002.002.042.082.122.162.20
2.252.252.302.352.402.442.48
2.502.502.552.602.652.702.75
2.752.752.812.872.932.993.05
3.003.003.073.143.213.283.35
3.253.253.323.393.463.533.60
3.503.503.583.663.743.803.87
3.753.753.833.913.994.064.13
4.004.004.084.164.244.324.40

Technical data should be read with the applicable approved Instructions for Use. Specifications and availability may vary by market.

CONFIGURATIONS

Ordering Information

Balloon Diameter (mm)Balloon Length (mm)Ordering Number
2.0006, 08, 10, 12, 15, 20, 35, 409220XX
2.2506, 08, 10, 12, 15, 20, 25, 30, 35, 4092225XX
2.5006, 08, 10, 12, 15, 20, 25, 30, 35, 409225XX
2.7506, 08, 10, 12, 15, 20, 25, 30, 35, 4092275XX
3.0006, 08, 10, 12, 15, 20, 25, 30, 35, 409230XX
3.2506, 08, 10, 12, 15, 20, 25, 30, 35, 4092325XX
3.5006, 08, 10, 12, 15, 20, 25, 30, 35, 409235XX
3.7506, 08, 10, 12, 15, 20, 25, 30, 35, 4092375XX
4.0006, 08, 10, 12, 15, 20, 25, 30, 35, 409240XX

XX denotes the selected length, including a leading zero where shown. Example: 2.25 mm diameter × 06 mm length: 9222506.

Confirm configurations and ordering information against the current approved product documentation.

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