Concept’s sirolimus DCB catheter gets breakthrough statusNovember 15, 2019
Concept Medical announced that the US FDA has granted breakthrough device designation for MagicTouch AVF, its sirolimus drug-coated balloon (DCB) catheter, for the treatment of stenotic lesions of arteriovenous fistulae or arteriovenous graft in haemodialysis treatment of renal failure.
A pilot study to investigate the safety and efficacy of Magic Touch PTA Sirolimus balloon in vascular access interventions was started in Singapore in 2018. The preliminary data using the Magic Touch sirolimus coated balloon (SCB) at the graft-vein junction of blocked AV grafts, and within native AV fistulas, have been promising to date, with an excellent safety profile and patient acceptability. Technical and procedural success has been 100%, the company said.