Erectile dysfunction (ED) is defined as the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse.
Assuring Safety by Delivering Sirolimus
An innovative proprietary Nanolute technology providing better bioavailability of SIROLIMUS
Unique coating technology leads to 100% balloon surface coating
Sirolimus: A drug with proven safety profile
A biocompatible phospholipid drug carrier improving the adhesion property of Sirolimus
Sirolimus Coated
Nanolute Technology
NANOLUTE TECHNOLOGY is designed to improve the lipophilicity and bioavailability of Sirolimus
- Phospholipid is a drug carrier with two lipophilic tails and one hydrophilic head.
- Sirolimus is encapsulated in phospholipid with proprietary Nanolute technology.
Nanolute Technology
- Conversion of Sirolimus drug into sub-micron sized particles
- Nanocarriers created by encapsulation of sub-micron sized
Sirolimus drug into highly biocompatible drug
Carrier-phospholipid - Upon inflation of MagicTouch SCB at target site, nanocarriers
with Sirolimus drug inside gets transferred to the vessel wall
following the principle of co-efficient diffusion - Upon body pH variation, nanocarriers mimics the body lipids and
liberates Sirolimus - The sub-micron sized Sirolimus drug particles penetrate the
deepest layer of the vessel over a period
Challenges Addressed by Nanolute Technology
Improves Lipophilicity of Sirolimus
- Lipophilicity is the ability of a drug to dissolve in fats, oils, lipids.
- Sirolimus possess poor lipophilicity and hence require phospholipid.
- NANOLUTE technology delivers polymer-free nanocarriers containing sirolimus surrounded by encapsulation of a
proprietary drug carrier, i.e., a phospholipid and improves lipophilicity.
Enhanced Bioavailibility of Sirolimus
- Bioavailability is a measure of the amount of a drug that reaches the target site.
- The bioavailability of sirolimus is poor due to higher wash-out rate in the blood stream.
- The coating of nanocarriers provides very low in-transit drug loss and better drug diffusion, as well as drug retention
throughout the artery, and penetration of sirolimus to the deep layers of the coronary artery results in enhanced
bioavailability.
Advantages of Nanolute Technology
Sirolimus Distribution Study
DTF labelled Sirolimus was used to study the drug distribution following DCB treatment*
ONE HOUR
ONE DAY
SEVEN DAYS
A: Adventitia; EEL: External Elastic Lamina; IEL: Internal Elastic Lamina; L:Lumen; M: Media *EuroIntervention. 2013 May 20;9(1): 148-56
TECHNICAL SPECIFICATION
| Drug / Excipient | |
| Drug | Sirolimus |
| Drug Dose | 1.27 µg/mm² |
| Drug Carrier | Phospholipid |
| Balloon | |
| Balloon Material | Polyamide |
| Catheter Design | Rx/Monorail |
| Delivery System | |
| Shaft Diameter (OD) | Proximal : 1.95 F |
| Shaft Diameter (OD) | Distal : 2.67 F |
| Usable Catheter Length | 140cm |
| Tip Profile | 0.016’’ |
| Nominal Pressure | 8 Bar |
| Rated Burst Pressure | 14 Bar |
| Guiding Catheter Compatibility | 6F |
| Guidewire Compatibility | 0.014’’ Maximum recommended |
| Size Available | |
| Balloon Length (mm) | 10, 15, 20 , 25, 30, 35, 40 |
| Balloon Diameter (mm) | 1.50, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00 |
