Magic Touch Fistula Drug Coated Sirolimus Balloon AVF

Assuring Safety by Delivering Sirolimus

• 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

  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.

  

  • 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

  • 

    Circumferential coating

  • 

   Sirolimus Distribution Study

  DTF labelled Sirolimus was used to study the drug distribution following DCB treatment*

  ONE HOUR

  DAY THREE

  DAY SEVEN

  A: Adventitia; EEL: External Elastic Lamina; IEL: Internal Elastic Lamina; L:Lumen; M: Media *EuroIntervention. 2013 May 20;9(1): 148-56

   Balloon Catheter

  

  TECHNICAL SPECIFICATION

  Drug	Sirolimus
  Drug Dose	1.27 µg/mm2
  Balloon Folding	3 & 6 folds
  Balloon Compliance	Semi-Compliant
  Sheath Compatibility	6F to 8F
  Guiding Catheter Compatibility	7F to 9F
  Balloon Diameter (mm)	3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00
  Balloon Length (mm)	20, 40, 60, 80, 100, 120, 150, 200
  Catheter Shaft Length (cm)	45, 80, 90, 130, 150
  Guide Wire Compatibility	0.035’’ OTW

  ORDERING INFORMATION

  Diameter/Length	20 mm	40 mm	60 mm	80 mm	100 mm
  3.00 mm	CMFW35001	CMFW35002	CMFW35003	CMFW35004	–
  4.00 mm	CMFW35005	CMFW35006	CMFW35007	CMFW35008	CMFW35009
  5.00 mm	CMFW35010	CMFW35011	CMFW35012	CMFW35013	CMFW35014
  6.00 mm	CMFW35015	CMFW35016	CMFW35017	CMFW35018	CMFW35019
  7.00 mm	CMFW35020	CMFW35021	CMFW35022	CMFW35023	CMFW35024
  8.00 mm	CMFW35025	CMFW35026	CMFW35027	CMFW35028	CMFW35029
  9.00 mm	CMFW35030	CMFW35031	CMFW35032	CMFW35033	–
  10.00 mm	CMFW35034	CMFW35035	CMFW35036	CMFW35037	–
  12.00 mm	CMFW35038	CMFW35039	CMFW35040	CMFW35041	–

  Clinical Programs

  Products Designed using Nanolute TECHNOLOGY