Sirolimus Coated

Balloon Catheter

Assuring Safety by Delivering Sirolimus

  • TECHNOLOGY

    An innovative proprietary Nanolute technology providing better bioavailability of SIROLIMUS

  • COATING

    Unique coating technology leads to 100% balloon surface coating

  • DRUG

    Sirolimus: A drug with proven safety profile

  • CARRIER

    A biocompatible phospholipid drug carrier improving the adhesion property of Sirolimus

Nanolute Technology

  • Conversion of Sirolimus drug into sub-micron sized particles
  • Encapsulation of sub-micron sized Sirolimus drug into highly biocompatible drug carrier-Phospholipid
  • Upon inflation of MagicTouch SCB at target site, drug carrier with Sirolimus drug inside gets transferred to the vessel wall following the principle of co-efficient diffusion
  • Upon body pH variation, drug carrier mimics the body lipids and liberates Sirolimus
  • The sub-micron sized Sirolimus drug particles penetrate the deepest layer of the vessel over a period

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

  • Better in-tissue bioavailability of Sirolimus

Sirolimus Distribution Study

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

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

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

Clinical Programs

MORE THAN 3,000 PATIENTS ENROLED AND PLANNED

Sr. No Study Name Type of Study Target Patients Country Principal Investigator
Sr. No:  01 Study Name:  NANOLUTE Type of Study:  Prospective, Multi-Center, Real world Target Patients:  450 Patients Country:  India Principal Investigator:  Dr. Sameer Dani
Sr. No:  02 Study Name:  FASICO* Type of Study:  Prospective, Single arm, Single-center Target Patients:  32 Patients Country:  Italy Principal Investigator:  Dr. Bernardo Cortese
Sr. No:  03 Study Name:  BRAZIL-FIM Type of Study:  Prospective, Multi-Center, Non-randomised, First-In-Man Target Patients:  30 Patients Country:  Brazil Principal Investigator:  Dr. Alexandre Abizaid
Sr. No:  04 Study Name:  EASTBOURNE Type of Study:  Prospective, Multi-Center, spontaneous clinical registry Target Patients:  2,000 Patients Country:  Global Principal Investigator:  Dr. Bernardo Cortese
Sr. No:  05 Study Name:  UK-SEB Type of Study:  Spontaneous, Clinical, Observational trial Target Patients:  500 Patients Country:  UK Principal Investigator:  Dr. Sandeep Basavarajaiah
Sr. No:  06 Study Name:  TRANSFORM I Type of Study:  Prospective, randomized , Multi-Center study Target Patients:  114 Patients Country:  Italy and UK Principal Investigator:  Prof. Antonio Colombo

* Cardiovascular Revascularization Medicine. 2017 Oct 1;18(7):487-91. Journal of Cardiovascular Medicine. 2019 Jul 1;20(7):471-6.)

“Confidence through evidence’’
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