SIROLIMUS-COATED PTA BALLOON CATHETER
Sirolimus Coated Balloon for
Dysfunctional AVF/AVG Stenotic Lesions
MagicTouch AVF is designed for hemodialysis access interventions, specifically addressing stenotic lesions in dysfunctional AV fistulas and grafts, with a focus on reducing recurrent interventions and supporting higher long-term patency.
Global evidence
Clinical program
Regulatory Milestone
Key Indications
AVF · AVG
Stenotic Lesions
Clinical Evidence in Dysfunctional AVF/Thrombosed AVG
From randomized controlled trials to real-world and pilot studies, MagicTouch AVF is supported by a growing body of clinical evidence in dysfunctional AVF and thrombosed AVG, demonstrating safety, efficacy, and sustained patency.
MATILDA · IMPRESSION RCT · MAGICTOUCH AVF IN SALVAGE OF AVF
MATILDA – MAgicTouch Intervention Leap for Dialysis Access Trial
33 patients evaluated in a prospective pilot study to assess the safety and efficacy of MagicTouch AVF in Dysfunctional AVF population with high comorbidity burden.
Principal Investigator: Prof. Tjun Tang
Hypertension
97%
Hyperlipidemia
90.9%
Diabetes Mellitus
63.6%
Juxta-Anastomotic Segments
40.4%
Clinical Outcomes
Technical & Procedural Success
Target Lesion Primary Patency
Comparative Outcomes at 1 Year: MATILDA vs ISABELLA
Target Lesion Primary Patency (Lesions)
Circuit Access Patency
Primary Assisted Patency
Secondary Patency
MagicTouch AVF demonstrated promising safety and efficacy, with high patency rates and no significant adverse events, supporting its use in dysfunctional AVF.
IMPRESSION RCT – Only RCT Demonstrating Superiority of SCB vs POBA
SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION
Investigator Initiated Prospective, single blinded RCT evaluating the superiority of MagicTouch AVF SCB against POBA in Matured Dysfunctional AVF. 170 patients randomized SCB: 83 | POBA: 87
Principal Investigator: Prof. Chieh Suai Tan
Diabetes Mellitus
66.7% vs 72.9%
Juxta-anastomosis
74.7% vs 80.5%
Cannulation Zone
41.0% vs 31%
≥2 Prior Interventions
27.7% vs 25.3%
Access Circuit Primary Patency*
*ITT Analyses
6-Month
12-Month
MagicTouch AVF demonstrated superior patency vs POBA in a randomized controlled trial, establishing strong clinical evidence in AVF intervention.
Use of SCB following successful plain balloon angioplasty improved 6-month ACPP in patients with dysfunctional AVFs, including those with multiple stenotic lesions. Short-term safety findings were reassuring. The results remained consistent through 12 months.
Reference: Presented by Prof. Chieh Suai Tan in LINC 2026. | Published in Kidney International Reports – DOI: 10.1016/j.ekir.2026.106583
MagicTouch AVF in Salvage of Thrombosed AVG
Sirolimus coated angioplasty balloon in the Salvage of Thrombosed Arteriovenous Graft
Pilot evaluation of SCB in thrombosed AVG access circuits to measure the Access Circuit Primary Patency at 3 months with long-term follow-up. 20 patients enrolled in a high-risk, complex dialysis population.
Principal Investigator: Prof Tan Chieh Suai
Complex Patient and Lesion Cohort
Hypertension
20%
Diabetes Mellitus
40%
de novo lesions
60%
1-Year Clinical Outcomes
Access Circuit Primary Patency
Assisted Primary Circuit Patency
Secondary Circuit Patency Rate
12-month patency – Higher than Expected
Sustained Intervention-Free Survival
MagicTouch AVF demonstrated strong outcomes in salvage of thrombosed AVG, supporting its role as a promising alternative to conventional therapies.
MagicTouch AVF demonstrated higher than expected primary patency at 12 months. The extended follow-up demonstrated sustained intervention-free survival of the AVGs following SCB angioplasty, suggesting that SCB may help to maintain the mid and long-term patency rates of thrombosed AVG
Reference: https://doi.org/10.1177/11297298221104310 | Presented in LINC 2022.
MagicTouch AVF
Sirolimus-coated, polymer-free balloon catheter
For treatment of stenotic lesions in dysfunctional arteriovenous fistula (AVF) and arteriovenous grafts (AVG)
- Circumferential coating for uniform drug distribution during inflation
- Optimized re-wrap to minimize drug loss during delivery
- Polymer-free design to support natural vessel healing
- Nanolute Technology for enhanced drug delivery and retention
Encapsulation of sub-micron Sirolimus in phospholipid carriers enables efficient drug transfer and improved vessel wall penetration, supporting sustained therapeutic effect in dialysis access
MagicTouch AVF at a glance
A next-generation Sirolimus Drug-Coated Balloon platform designed for dialysis access, combining precision drug delivery, clinical validation, and real-world performance.
MagicTouch AVF is a Sirolimus-coated, polymer-free balloon catheter designed for the treatment of dysfunctional AVF and AVG, enabling uniform drug delivery and sustained therapeutic outcomes.
Supported by a growing clinical program including 6 studies covering 1200+ patients in dysfunctional AVF and thrombosed AVG interventions.
Key Indication
Indicated for treatment of stenotic lesions in dysfunctional AVF and AVG, including thrombosed grafts.
- Stenotic Lesions in dialysis patients especially
- Thrombosed Graft
An optimized balloon platform designed to navigate complex dialysis access anatomies.
Multiple sizes and lengths support tailored treatment strategies across diverse AV access anatomies.
Why Sirolimus for AV Access?
Sirolimus provides anti-proliferative and anti-inflammatory effects, helping reduce neointimal hyperplasia, the key cause of AVF/AVG restenosis while supporting controlled vascular healing.
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 AVF integrates advanced Sirolimus delivery technology with an optimized balloon platform to ensure consistent performance in dialysis access interventions.
Built for Dialysis Access Complexity
Designed to address the challenges of AVF and AVG interventions, including restenosis, thrombosis, and repeated procedures.
- Optimized crossing profile
- High flexibility
- Stable coating integrity
- Wide portfolio coverage
Clinical resources &
next steps
MagicTouch AVF
Access product details
For use only in countries where MagicTouch AVF is registered with applicable health authorities. Approved by USFDA use in clinical trials only.