Sirolimus Coated Balloon Catheter
Features and Benefits
1. Drug SIROLIMUS
- Drug Dose:180µg on 3.00 X 15mm (1.27µg/mm2 )
- Most widely used drug by Cardiologists for CAD
- Difficult to deliver due to low Lipophilicity
- Cytostatic, avoiding toxic effects unlike Paclitaxel
- Good history of use
- Very Difficult to coat without a Polymeric Carrier
- Slow drug uptake, hence longer time required at site.
2. NANOLUTE (Proprietary Nano carrier drug delivery technology)
NanoluteTM Technology is a nano-carrier based drug delivery technology where nano sized encapsulated carriers; carries anti-proliferative drug inside of the carrier.
The following are the advantages of NanoluteTM technology:
- Uniform coating surface
- Reduced in-transit loss of drug
- Increased bio-availability of drug
- Better bio-compatibility of drug
- Encapsulation enhances drug retention
- Faster uptake of drug in tissue on delivery
- Drug released on dissolution of naocarrier
- Programmable drug release from surface of device
3. CLINICAL Data (NANOLUTE STUDY)
POST MARKET CLINICAL FOLLOW UP
The Nanolute multi-centre Registry for clinical evaluation of Sirolimus Coated Balloon which enrolled real world, all comer patients from the routine clinical practice at various interventional cardiology sites in India.
This Clinical registry is conducted in compliance with the ISO: 14155 and all applicable regulatory requirements.
Purpose of this registry is to evaluate the safety and efficacy of Sirolimus Coated Balloon in the patients with Coronary Artery Disease.
Prospective, Multi-centre clinical registry enrolls real world, all comers patients from the routine clinical practice at various Interventional Cardiology Sites. All patients have Clinical Follow-up at 1, 6 and 12 Months.