SIROLIMUS-COATED PTA · BTK · SFA · ILIAC
Sirolimus Coated Balloon for
Complex Peripheral Disease
MagicTouch PTA is a Sirolimus coated, polymer-free PTA balloon engineered for predictable drug
delivery in superficial femoral (SFA), popliteal, below-the-knee (BTK) and iliac artery. Powered by
Nanolute® Technology, it delivers sub-micron Sirolimus particles deeply into the vessel wall with
controlled release for up to 120 days.
Global evidence
Patients across RCTs & registries
0
+
Clinical program
Clinical Trials
1
Therapeutic window
Programmed Sirolimus availability
0
Days
Vascular beds
BTK · SFA
Popliteal · Iliac
Clinical evidence across
BTK, SFA & CLTI
From BTK CLTI registries to head-to-head SFA randomized trials and 3-year follow-up data, MagicTouch PTA is
supported by a uniquely broad Sirolimus DCB evidence base.
Select data set
HOPE BTK · SIRONA SFA · XTOSI 3-year
BTK · HOPE
SFA · SIRONA RCT
PAD · XTOSI
BTK · HOPE
HOPE BTK Registry – durable 3-year outcomes in high-risk CLTI patients
318 BTK patients (133 MagicTouch PTA; 185 POBA) with high prevalence of diabetes, advanced Rutherford class and elevated WIFI scores were followed to 3 years.
Complex CLTI cohort (SCB v/s POBA)
Diabetes
91% vs 89%
ASA Score (3)
78% vs 76%
WIFI Score
4.1 ± 1.8 vs 3.9 ± 1.9
ESRD
23% vs 22%
3-year comparative outcomes vs POBA
Freedom from TLR
MagicTouch PTA
76.5%
POBA
64.9%
HR 0.58 · 95% CI 0.35–0.96 · p=0.033
Freedom from Major Amputation
MagicTouch PTA
92.8%
POBA
85.7%
HR 0.62 (95% CI 0.25-1.56) p=0.32
Amputation-Free Survival (AFS)
MagicTouch PTA
60.9%
POBA
47.4%
HR 0.66 · 95% CI 0.47–0.92 · p=0.014.
Overall Survival
MagicTouch PTA
62.4%
POBA
53.9%
HR 0.71 · 95% CI 0.50–0.99 · p=0.049.
In a challenging BTK CLTI population, MagicTouch PTA demonstrated improved freedom from TLR, superior amputation-free survival and better overall survival vs POBA at 3 years, with good limb preservation.
BTK perspective
HOPE BTK reflects the reality of high-risk CLTI – diabetic, multi-morbid patients with advanced wound and ischemia burden.
The 3-year signal supports the role of Sirolimus DCB therapy in BTK lesions, where durability and limb salvage are critical.
Principal Investigator: Prof. Edward Choke
SFA · SIRONA RCT
SIRONA – first RCT of Sirolimus DCB vs Paclitaxel DCB in SFA to prove non-inferiority
482 – patients (MagicTouch PTA 238 : Paclitaxel 244) to compare primary patency at 1 year in SFA disease, with additional clinical and safety endpoints.
Complex SFA cohort (MagicTouch PTA v/s Paclitaxel DCB)
Rutherford Becker (3)
72.7% vs 68.9%
Diabetes
34% vs 33.2%
Lesion length:(mm)
84.3 ± 61.7 vs 84.1 ± 60.1 mm
Promising Clinical Outcomes with MagicTouch PTA showing non-inferiority in primary patency
Primary Patency at 1 Year
MagicTouch PTA – (150/203)
| Paclitaxel DCB (149/199) 73.9%
| Paclitaxel DCB (149/199) 73.9%
Paclitaxel DCB
74.9%
Rate difference꞉ ‑1.0% (‑9.6% to 7.6%)
P = 0.019 (non‑inferiority)
Rutherford Improvement ≥1 class
MagicTouch PTA
88.8%
Paclitaxel DCB
90.0%
Comparable symptomatic improvement at 1 year.
P = 0.75 | Rate difference = ‑1.2% (95% CI꞉ ‑7.3 to 4.9)
P = 0.75 | Rate difference = ‑1.2% (95% CI꞉ ‑7.3 to 4.9)
Freedom From Composite Safety Endpoint (1 year)
MagicTouch PTA
90.5%
Paclitaxel DCB
92.7%
Non-inferior safety profile · p=0.003.
2-Year Freedom from cd-TLR
Kaplan–Meier analysis shows sustained, comparable cd-TLR freedom between Sirolimus and Paclitaxel DCB arms over 2 years.
SIRONA demonstrates that Sirolimus DCB therapy with MagicTouch PTA is non-inferior to Paclitaxel DCB in SFA disease, in terms of Primary Patency, with improvement in safety and functional endpoints – providing physicians with a robust Sirolimus-based alternative.
Why it matters
SIRONA is the only head-to-head peripheral RCT between Sirolimus and Paclitaxel DCB, which proves the non-inferiority of MagicTouch PTA at 1 year for primary patency.
It supports the transition towards Sirolimus-based therapy without compromising clinical outcomes.
Principal Investigator: Prof. Ulf Teichgräber
PAD · XTOSI
XTOSI – 3-year Sirolimus DCB outcomes in high-risk PAD
XTOSI (50 patients study) provides extended 3-year safety and efficacy data for MagicTouch PTA in high-risk CLTI patients, focusing on re-intervention, limb preservation and ulcer healing.
Complex CLTI Patients
Diabetes
90%
WIFI Score (4-8)
58%
Dialysis
20%
CAD
36%
3-year outcomes
Freedom from cd-TLR
3-year cd-TLR freedom
84.4%
Durable reduction in repeat interventions over 3 years.
Freedom from Major Amputation
Freedom from Major Amputation at 3 years
86.1%
High level of limb preservation across follow-up.
Amputation-Free Survival
AFS at 3 years
63.3%
Combined assessment of survival and limb salvage in a high-risk CLTI cohort.
Ulcer Healing (Survivors With Intact Limbs)
Ulcer-free
100%
Complete ulcer healing in remaining survivors with preserved limbs at 3 years.
XTOSI confirms that the clinical benefit of Sirolimus DCB therapy with MagicTouch PTA extends to 3 years in high-risk CLTI Patients, with sustained cd-TLR freedom, limb salvage and full ulcer healing among survivors with intact limbs.
Long-term confidence
Three-year data are critical in CLTI, where success is defined not only by patency, but by durable limb preservation and wound resolution.
XTOSI reinforces the long-term safety and efficacy profile of Sirolimus DCB therapy in complex peripheral disease.
Principal Investigator : Prof. Edward Choke
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.
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.
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.
powerful alternative to Paclitaxel for peripheral DCB therapy.
- 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.
- Sirolimus ➝ Nanocarrier
- Nanocarrier ➝ Vessel wall
- Vessel wall ➝ Release up to 120 days
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.
balance deliverability and deep, sustained drug transfer.
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.
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.