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
Clinical program
Therapeutic window
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.
HOPE BTK · SIRONA SFA · XTOSI
SirPAD – randomized trial of Sirolimus-Coated Balloon vs Uncoated Balloon in infrainguinal artery disease
1252 patients (626 sirolimus-coated balloon; 626 uncoated balloon) with symptomatic infrainguinal artery disease were enrolled in a multicenter, prospective, randomized (1:1), open-label trial and followed for 1-year primary endpoint outcomes.
Diabetes
43.9% vs 46.5%
Hypertension
77.0% vs 77.2%
Coronary artery disease:
41.1% vs 43.3%
1-Year Results Published in the New England Journal of Medicine
Primary outcome – MALE (major adverse limb events)
P<0.001for noninferiority | P=0.009 for superiority.
*Absolute Risk Difference of the Median Unbiased Estimate of the (95% CI)
Individual Components of the Primary Outcome at one year
Unplanned Target ‑ Limb Amputations
TLR for Critical Limb Ischemia
Secondary Outcome (Composite)
Unplanned Target ‑ Limb Amputations
P = 0.002 for superiority
Individual Components of the Secondary Outcome at one year
Any unplanned target-limb amputation
TLR for critical or noncritical limb ischemia
The SirPAD randomized trial, the world’s largest all‑comers PAD study, demonstrates that MagicTouch PTA sirolimus coated balloon angioplasty is both noninferior and superior to standard uncoated balloon angioplasty for the primary one‑year outcome of major adverse limb events.
Insights from the Principal Investigators
“We are excited about the primary outcome results of SirPAD. It is one of the very few trials in this field that successfully included an all-comers population, meaning consecutive patients without eligibility restrictions related to target-lesion characteristics or PAD stage. This led to nearly 50% of enrolled patients having acute or chronic limb-threatening ischemia, thereby providing enough events and statistical power to demonstrate superiority for hard clinical outcomes at one year.”
Principal Investigator: Dr. med. Nils Kucher | Prof. Dr. med. Stefano Barco
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 3 year in SFA disease, with additional clinical and safety endpoints.
Complex SFA cohort (MagicTouch PTA v/s Paclitaxel DCB)
Rutherford Becker (3)
73% vs 69%
Diabetes
34% vs 32%
Lesion length:(mm)
84 ± 62 mm vs 84 ± 60 mm
Promising Clinical Outcomes with MagicTouch PTA showing non-inferiority in primary patency
Freedom from cdTLR
88.2%
Freedom from Major Amputation
Log – rank p = 0.61 | HR 0.54 = (95% CI, 0.04 -5.96)
Freedom From all-cause morality
36-month clinical outcomes from the world’s only head-to-head randomised controlled trial comparing Sirolimus vs Paclitaxel-coated balloons, demonstrating MagicTouch PTA superiority over Paclitaxel-coated balloons in SFA treatment for cd-TLR.
Presented at CX 2026.
SIRONA is the only head-to-head peripheral RCT comparing Sirolimus and Paclitaxel DCB, now extended to 3-year outcomes.
At 3 years:
- Improved outcomes in freedom from clinically driven TLR
- Comparable results in mortality and major amputation
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.
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
Freedom from Major Amputation
Amputation-Free Survival (AFS)
Overall Survival
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.
HOPE BTK Registry – durable 4-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 4 years.
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%
4-years comparative outcomes vs POBA
Freedom from TLR
Freedom from Major Amputation
Overall Survival
At 4 years in the HOPE BTK study, MagicTouch PTA continued to show sustained clinical benefit over POBA, with stronger vessel durability and improved long-term survival outcomes in a challenging BTK CLTI population.
Principal Investigator: Prof. Edward Choke
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.
Diabetes
90%
WIFI Score (4-8)
58%
Dialysis
20%
CAD
36%
3-year outcomes
Freedom from cd-TLR
Freedom from Major Amputation
Amputation-Free Survival
Ulcer Healing (Survivors With Intact Limbs)
MagicTouch PTA
- 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.
carriers enables deeper vessel wall penetration.
120 days, aligning with the vascular healing window.
MagicTouch PTA at a glance
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.
- Superficial femoral artery (SFA)
- Popliteal artery
- Below-the-knee arteries (BTK)
- Iliac arteries
- Low tip profile
- High trackability
- Improved pushability
- IStable re-wrap
Why Sirolimus for peripheral interventions?
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 &
Device Engineering
balance deliverability and deep, sustained drug transfer.
Programmed release kinetics maintain Sirolimus availability within the target tissue for up to 120 days.
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
MagicTouch PTA
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