Sirolimus Coated Balloon Catheter
Novel, First of its kind Sirolimus drug coated balloon catheter for the treatment of coronary artery disease
MagicTouch is intended for in-stent restenosis, small vessels, bifurcation lesions and de-novo lesions
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
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Unique Coating Technology
Drug carrier along with drug is coated on the unfolded balloon to achieve 100% coating on balloon surface
Unique and proprietary refolding mechanism facilitates better crossing profile
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
* Facilitates better adhesion of Sirolimus on the balloon surface
* Effective drug transfer to the deepest layer of the vessel
* Circumferencial coating
* Better in-tissue bioavailability of Sirolimus
Sirolimus Distribution Study
DTF labelled Sirolimus was used to study the drug distribution following DCB treatment*
ONE HOUR
ONE DAY
SEVEN DAYSA: 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 1.27µg/mm² Drug Carrier Phospholipid Based Excipient Balloon Balloon Material Polyamide Catheter design Rapid Exchange(RX) Design Delivery system Shaft Diameter – Proximal 1.7 F Shaft Diameter – Distal 2.5 F Usable Catheter Length 140 cm Tip Profile 0.016” Nominal Pressure 6 bar Rated Burst Pressure 16 bar (14 bar for 4.00/ 25 to 40 mm) Guiding Catheter Compatibility 6F Guidewire Compatibility 0.014” maximum recommended ORDERING INFORMATION :
Diameter/Length 10 mm 15 mm 20 mm 25 mm 30 mm 35 mm 40 mm 1.50 mm CMN15010 CMN15015 CMN15020 CMN15025 CMN15030 CMN15035 CMN15040 2.00 mm CMN20010 CMN20015 CMN20020 CMN20025 CMN20030 CMN20035 CMN20040 2.25 mm CMN22510 CMN22515 CMN22520 CMN22525 CMN22530 CMN22535 CMN22540 2.50 mm CMN25010 CMN25015 CMN25020 CMN25025 CMN25030 CMN25035 CMN25040 2.75 mm CMN27510 CMN27515 CMN27520 CMN27525 CMN27530 CMN27535 CMN27540 3.00 mm CMN30010 CMN30015 CMN30020 CMN30025 CMN30030 CMN30035 CMN30040 3.50 mm CMN35010 CMN35015 CMN35020 CMN35025 CMN35030 CMN35035 CMN35040 4.00 mm CMN40010 CMN40015 CMN40020 CMN40025 CMN40030 CMN40035 CMN40040 Clinical Programs :
