Luminor
Balloon Dilation PTA Catheter with Paclitaxel
iVascular | Luminor / Balloon Dilation PTA Catheter with Paclitaxel
iVascular | Luminor / Balloon Dilation PTA Catheter with Paclitaxel
iVascular | Luminor / Balloon Dilation PTA Catheter with Paclitaxel
iVascular | Luminor / Balloon Dilation PTA Catheter with Paclitaxel
- Catheter materials: Nylon / Pebax (latex-free components)
- Pharmaceutical agent: Paclitaxel 3 µg/mm²
- Excipients: Organic ether. Lipophilic, biocompatible, and biodegradable
- Balloon: Semi-compliant (10-15% from nominal pressure to RBP)
- Nominal pressure: 7 atm
- RBP (Rated burst pressure): 16 atm
- ABP (Actual burst pressure): 20 atm
- Recommended guide wire: 0.018″ (0.014″ compatible)
- Crossing profile: From 0.035″ to 0.063″
- Tip profile: Maximum 0.019″
- Introducer compatibility: 4F (d: 2–5 mm) | 5F (d: 6–8 mm)
- Deflation time: <8 s
- Useful catheter length: 100 cm, 140 cm, and 150 cm
Specifications Luminor 18
- Catheter materials: Nylon / Pebax (latex-free components)
- Pharmaceutical agent: Paclitaxel 3 µg/mm²
- Excipients: Organic ether. Lipophilic, biocompatible, and biodegradable
- Balloon: Semi-compliant (10-15% from nominal pressure to RBP)
- Nominal pressure: 7 atm
- RBP (Rated burst pressure): 16 atm
- ABP (Actual burst pressure): 22 atm
- Recommended guide wire: 0.014″
- Crossing profile: From 0.026″ to 0.042″
- Tip profile: 0.017″
- Introducer compatibility: 4F for all diameters
- Deflation time: <5 s
- Useful catheter length: 100 cm and 150 cm
Specifications Luminor 14
- Catheter materials: Nylon / Pebax (product is latex-free)
- Pharmaceutical agent: Paclitaxel 3 µg/mm²
- Excipients: Organic ether. Lipophilic, biocompatible, and biodegradable
- Balloon: Semi-compliant (10-15% from nominal pressure to RBP)
- Nominal pressure: 6/7 atm
- RBP (Rated burst pressure): 16 atm
- ABP (Actual burst pressure): 23 atm
- Recommended guide wire: 0.035″
- Crossing profile: From 0.065 to 0.077″
- Tip profile: 0.036″
- Introducer compatibility: 5F (d = 5 mm), 6F (d = 6 mm, d = 7 mm)
- Deflation time: <5 s
- Useful catheter length: 80 cm and 140 cm
Specifications Luminor 35
TransferTech
iVascular's patented nanotechnology coating, where paclitaxel is used in a microcrystalline structure and, along with the filler, is distributed on the balloon through impulse ultrasonic spraying. The surface of the balloon is coated with several independent nanodroplet layers. This unique and innovative technology ensures a flexible coating that adapts to the movement of the balloon.
Description
The Luminor balloon, which releases paclitaxel, is a dual-lumen catheter from the connector to the tip (also called a guide wire, OTW), designed for percutaneous transluminal angioplasty of large peripheral arteries.
The guide wire passes through the largest round lumen, while the smallest elliptical lumen is intended for the contrast medium flow.
The maximum guide wire diameter should not exceed 0.89 mm (0.035 inches).
At the distal part of the catheter, just before the tip, is the balloon (inflatable segment) which dilates the artery by infusing contrast fluid inside it. The Y-shaped connector has two entry ports:
Luminor is coated with a homogeneous mixture of paclitaxel, a taxol derivative, and a physiologically harmless matrix filler. The drug dose is 3 μg/mm² of the balloon surface area, intended to prevent cellular proliferation, reducing the frequency of restenosis.
The drug is released from the balloon by rapid inflation, so a large dose is delivered in a very short period. To ensure sufficient paclitaxel dose into the arterial wall, the inflation process should last from 30 seconds to 1 minute. The lesion expansion can be optimized by increasing the inflation time at the operator's discretion.
The balloon is designed to achieve different diameters at varying pressures, as predicted by the conformity curve included in the primary packaging.
Two radiopaque markers made of Pt/Ir alloy are placed at both ends of the balloon to indicate its length and assist the user in visualizing the catheter during navigation inside the patient.
At the distal end is a very soft, rounded tip made from polymer, forming a non-traumatic shape to prevent artery wall damage during navigation.
The catheter shaft is coated with a patented hydrophilic formula to minimize friction.
The guide wire passes through the largest round lumen, while the smallest elliptical lumen is intended for the contrast medium flow.
The maximum guide wire diameter should not exceed 0.89 mm (0.035 inches).
At the distal part of the catheter, just before the tip, is the balloon (inflatable segment) which dilates the artery by infusing contrast fluid inside it. The Y-shaped connector has two entry ports:
- The direct port is for the guide wire.
- The side port allows the contrast medium flow to inflate the balloon.
Luminor is coated with a homogeneous mixture of paclitaxel, a taxol derivative, and a physiologically harmless matrix filler. The drug dose is 3 μg/mm² of the balloon surface area, intended to prevent cellular proliferation, reducing the frequency of restenosis.
The drug is released from the balloon by rapid inflation, so a large dose is delivered in a very short period. To ensure sufficient paclitaxel dose into the arterial wall, the inflation process should last from 30 seconds to 1 minute. The lesion expansion can be optimized by increasing the inflation time at the operator's discretion.
The balloon is designed to achieve different diameters at varying pressures, as predicted by the conformity curve included in the primary packaging.
Two radiopaque markers made of Pt/Ir alloy are placed at both ends of the balloon to indicate its length and assist the user in visualizing the catheter during navigation inside the patient.
At the distal end is a very soft, rounded tip made from polymer, forming a non-traumatic shape to prevent artery wall damage during navigation.
The catheter shaft is coated with a patented hydrophilic formula to minimize friction.