MagicTouch: Sirolimus Drug Coated Balloon Catheter
MagicTouch SCB - Concept Medical - Developing technologies for drug delivery with a strong emphasis on intellectual property.

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

Sirolimus Coated

Balloon Catheter

MagicTouch SCB

Assuring Safety by Delivering Sirolimus

  • TECHNOLOGY - MagicTouch SCB

    TECHNOLOGY

    An innovative proprietary Nanolute technology providing better bioavailability of SIROLIMUS

  • COATING - MagicTouch SCB

    COATING

    Unique coating technology leads to 100% balloon surface coating

  • DRUG - MagicTouch SCB

    DRUG

    Sirolimus: A drug with proven safety profile

  • CARRIER - MagicTouch SCB

    CARRIER

    A biocompatible phospholipid drug carrier improving the adhesion property of Sirolimus

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.

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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

TECHNICAL SPECIFICATION

DRUG/EXCIPIENT
DrugSirolimus
Drug Dose1.27µg/mm²
Drug CarrierPhospholipid Based Excipient
Balloon
Balloon MaterialPolyamide
Catheter designRapid Exchange(RX) Design
Delivery system
Shaft Diameter – Proximal1.7 F
Shaft Diameter – Distal2.5 F
Usable Catheter Length140 cm
Tip Profile0.016”
Nominal Pressure6 bar
Rated Burst Pressure16 bar (14 bar for 4.00/ 25 to 40 mm)
Guiding Catheter Compatibility6F
Guidewire Compatibility0.014” maximum recommended

ORDERING INFORMATION

Diameter/Length10 mm15 mm20 mm25 mm30 mm35 mm40 mm
1.50 mmCMT15010CMT15015CMT15020CMT15025CMT15030CMT15035CMT15040
2.00 mmCMT20010CMT20015CMT20020CMT20025CMT20030CMT20035CMT20040
2.25 mmCMT22510CMT22515CMT22520CMT22525CMT22530CMT22535CMT22540
2.50 mmCMT25010CMT25015CMT25020CMT25025CMT25030CMT25035CMT25040
2.75 mmCMT27510CMT27515CMT27520CMT27525CMT27530CMT27535CMT27540
3.00 mmCMT30010CMT30015CMT30020CMT30025CMT30030CMT30035CMT30040
3.50 mmCMT35010CMT35015CMT35020CMT35025CMT35030CMT35035CMT35040
4.00 mmCMT40010CMT40015CMT40020CMT40025CMT40030CMT40035CMT40040

 

For Concept Medical BV

Diameter/Length10 mm15 mm20 mm25 mm30 mm35 mm40 mm
1.50 mmCMN15010CMN15015CMN15020CMN15025CMN15030CMN15035CMN15040
2.00 mmCMN20010CMN20015CMN20020CMN20025CMN20030CMN20035CMN20040
2.25 mmCMN22510CMN22515CMN22520CMN22525CMN22530CMN22535CMN22540
2.50 mmCMN25010CMN25015CMN25020CMN25025CMN25030CMN25035CMN25040
2.75 mmCMN27510CMN27515CMN27520CMN27525CMN27530CMN27535CMN27540
3.00 mmCMN30010CMN30015CMN30020CMN30025CMN30030CMN30035CMN30040
3.50 mmCMN35010CMN35015CMN35020CMN35025CMN35030CMN35035CMN35040
4.00 mmCMN40010CMN40015CMN40020CMN40025CMN40030CMN40035CMN40040
MagicTouch SCB

Clinical Programs

Sr. NoStudy NameType of StudyTarget PatientsCountryClinical Trials Identifier
Sr. No:  1Study Name:   EASTBOURNE Type of Study:  Prospective, Multi-Center, spontaneous clinical registryTarget Patients:  2123Country:  India, Malaysia, Greece, Italy, Spain, IrelandClinical Trials Identifier:  https://clinicaltrials.gov/ct2/show/NCT03085823
Sr. No:  2Study Name:   Nanolute Type of Study:  Prospective, Multi-Center, Real worldTarget Patients:  450Country:  IndiaClinical Trials Identifier:  
Sr. No:  3Study Name:   Transform I Type of Study:  Prospective, randomized , Multi-Center studyTarget Patients:  120Country:  Italy, UK, IrelandClinical Trials Identifier:  https://clinicaltrials.gov/ct2/show/NCT03913832
Sr. No:  4Study Name:   Brazil-FIM Type of Study:  Prospective, Multi-Center, Non-randomised, First-In-ManTarget Patients:  30Country:  BrazilClinical Trials Identifier:  https://clinicaltrials.gov/ct2/show/NCT02400632
Sr. No:  5Study Name:   FASICO Type of Study:  Prospective, Single arm, Single-centerTarget Patients:  32Country:  ItalyClinical Trials Identifier:  
Sr. No:  6Study Name:   UK-SEB REGISTRY Type of Study:  Spontaneous, Clinical, Observational trialTarget Patients:  500Country:  UKClinical Trials Identifier:  
Sr. No:  7Study Name:   Nanolute CIMS Type of Study:  Target Patients:  131Country:  IndiaClinical Trials Identifier:  
Sr. No:  8Study Name:   SELFIE Type of Study:  Target Patients:  62Country:  ItalyClinical Trials Identifier:  
Sr. No:  9Study Name:   JAPAN - ISR Type of Study:  Target Patients:  50Country:  JapanClinical Trials Identifier:  
Sr. No:  10Study Name:   Japan – SV Type of Study:  Target Patients:  170Country:  JapanClinical Trials Identifier:  
Sr. No:  11Study Name:   UK-SEB REGISTRY 2 Type of Study:  Target Patients:  1000Country:  UKClinical Trials Identifier:  
Sr. No:  12Study Name:   TRANFORM II Type of Study:  Target Patients:  1325Country:  Italy, UK, Poland, Spain, Portugal, The NetherlandsClinical Trials Identifier:  https://clinicaltrials.gov/ct2/show/NCT04893291
Sr. No:  13Study Name:   GINGER Type of Study:  Target Patients:  100Country:  Clinical Trials Identifier:  
Sr. No:  14Study Name:   TITAN Type of Study:  Target Patients:  130Country:  Clinical Trials Identifier:  
Sr. No:  15Study Name:   MAGICAL SV Type of Study:  Target Patients:  1605Country:  Clinical Trials Identifier:  
Sr. No:  16Study Name:   MAGICAL ISR Type of Study:  Target Patients:  492Country:  Clinical Trials Identifier:  
Sr. No:  17Study Name:   Hybrid Bifurcation PCI Type of Study:  Target Patients:  500Country:  Clinical Trials Identifier:  
“Confidence through evidence”
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