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SIROLIMUS-COATED BALLOON: DE NOVO LESIONS · IN-STENT RESTENOSIS · SMALL VESSELS BIFURCATION LESIONS

Clinical Evidence for

MagicTouch SCB

MagicTouch SCB is a polymer-free Sirolimus coated balloon catheter designed for the treatment of coronary artery disease, including de novo lesions, in-stent restenosis (ISR), small vessels, and bifurcation lesions.Engineered with Nanolute Technology, it enables deep vessel wall penetration and sustained drug delivery, supporting optimal vascular healing.

Global evidence

Patients across global clinical studies
0 +

Clinical program

Extensive global clinical evaluation
1

In-Tissue Drug Presence

Sustained Sirolimus availability
0 Days

USFDA IDE APPROVED

ISR · SV

Regulatory Milestone

Clinical Evidence Across Coronary Artery Disease

From real-world registries to investigator-driven global studies, MagicTouch SCB is supported by comprehensive clinical evidence base across de novo lesions, ISR, small vessels & complex ACS populations.

Select data set

· EASTBOURNE · UK-SEB 2 · SELFIE REGISTRY · FASICO · PICCOLETO VI · NANOLUTE

Peripheral DCB Platform

MagicTouch PTA

Sirolimus-coated, polymer-free PTA balloon catheter
For PTA of de-novo, stenotic and in-stent restenotic lesions in SFA, popliteal, BTK & iliac arteries.
Key attributes
  • Circumferential coating for uniform drug distribution at low inflation pressure.
  • Optimized re-wrap to minimize in-transit drug loss.
  • US FDA IDE approval in both Below-the-Knee (BTK) and Superficial Femoral Artery (SFA) indications.
Nanolute® Technology
Encapsulation of sub-micron Sirolimus in phospholipid
carriers enables deeper vessel wall penetration.
Programmed Release
Sirolimus availability in target tissue maintained for up to
120 days, aligning with the vascular healing window.

MagicTouch PTA at a glance

A bold evolution in peripheral DCB therapy: polymer-free Sirolimus coating, high deliverability and a clinical program built around real-world complexity.
Product overview
MagicTouch PTA is a Sirolimus coated, polymer-free PTA balloon intended for percutaneous transluminal angioplasty of de-novo, stenotic and in-stent restenotic lesions in superficial femoral (SFA), popliteal, below-the-knee (BTK) and iliac arteries.

Circumferential coating enables uniform Sirolimus distribution at low inflation pressures, while the Nanolute® platform delivers sub-micron particles deeply into the vessel wall.

  • Sirolimus coated · Polymer free
  • Circumferential low-pressure coating
  • Nanolute® sub-micron delivery
  • Deep vessel wall penetration
  • Low tip entry profile
  • Optimized re-wrap stability
  • Wide size matrix

Supported by a robust trial program including 8 RCTs, and 3 trials covering ~4000 patients in SFA, BTK and complex CLTI disease.

Target vascular beds
Indicated for treatment of de-novo, stenotic and in-stent restenotic lesions in:
  • Superficial femoral artery (SFA)
  • Popliteal artery
  • Below-the-knee arteries (BTK)
  • Iliac arteries
Engineered deliverability
A low entry tip profile and enhanced shaft design support crossing long, calcified and tortuous segments, including distal BTK and challenging SFA anatomies.
  • Low tip profile
  • High trackability
  • Improved pushability
  • IStable re-wrap
Multiple lengths and diameters allow tailored treatment strategies across a wide spectrum of peripheral lesions.

Why Sirolimus for peripheral interventions?

Sirolimus delivers anti-proliferative and anti-inflammatory effects with a broad therapeutic window – a
powerful alternative to Paclitaxel for peripheral DCB therapy.
Sirolimus Coated Balloon - Concept Medical
  • Sirolimus is a widely validated anti-proliferative drug that inhibits smooth muscle cell proliferation and modulates inflammatory pathways, helping to limit neointimal hyperplasia.
  • Sub-micron Sirolimus particles in Nanolute® Technology enable deeper penetration into the vessel wall, improving biological effectiveness.
  • A broad therapeutic margin and well-defined pharmacokinetics underpin predictable and controlled vascular healing.
  • Extensive experience across coronary and peripheral applications positions Sirolimus as a preferred alternative to Paclitaxel for many physicians.

From balloon to vessel wall

Nanolute® Technology is designed to synchronize Sirolimus delivery and retention with the vessel healing timeline.

Nanolute® Technology &
Device Engineering

MagicTouch PTA integrates proprietary Sirolimus delivery technology with a low-profile PTA balloon platform to
balance deliverability and deep, sustained drug transfer.
MagicTouch PTA Drug-Coated Balloon Clinical Evidence - Container
Core Technology Pillars
Sub-micron Sirolimus particles are encapsulated in phospholipid nanocarriers to promote deeper vessel wall penetration.
Circumferential low-pressure coating ensures uniform Sirolimus distribution around the vessel lumen during inflation.

Programmed release kinetics maintain Sirolimus availability within the target tissue for up to 120 days.

Optimized balloon re-wrap helps minimize in-transit drug loss and preserve coating integrity during navigation and deployment.
Built for Complex Anatomy
A low crossing profile, enhanced pushability and flexibility support access to distal BTK
and tortuous SFA segments, even in long or calcified lesions.
  • Optimized crossing profile
  • High flexibility
  • Stable coating integrity
  • Wide portfolio coverage

Clinical resources &
next steps

Access detailed study data, product documentation and dedicated support from the Concept Medical team.
Downloads & Support
Download clinical summaries

HOPE BTK – 3-year registry

Complete 3-year outcomes data

Product Documentation

Access product details

The law restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use (IFU) for full indications, contraindications, warnings and precautions.
For use only in countries where MagicTouch PTA is registered with applicable health authorities. Approved by USFDA use in clinical trials only.