FDA granted breakthrough device designation to MagicTouch AVF sirolimus-coated balloon

FDA granted the breakthrough device designation for MagicTouch AVF, its sirolimus drug-coated balloon (DCB) catheter used for treating the stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure.

The indications which were proposed for the breakthrough device designation for the MagicTouch sirolimus-coated balloon catheter are, directed for use in percutaneous transluminal angioplasty (PTA), after appropriate preparation of vessel for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistula or graft with 4–12 mm diameter and up to 100mm in length.

This is the world’s first pilot study for investigation of the safety and efficacy of Magic Touch percutaneous transluminal angioplasty (PTA) sirolimus balloon in vascular access interventions which was started in Singapore in 2018.

The organization is still in the primarily stage in the clinical study of drug-coated balloons for hemodialysis access patients. The technology which is paclitaxel-based study has results which certainly have been encouraging, but more research is needed to determine if other devices may prove to be effective more or uniquely beneficial for specific anatomical or clinical subtype presentations.