A breakthrough device sirolimus drug-coated balloon (DCB) for treating of coronary in-stent restenosis (ISR) has been launched.
In-Stent Restenosis (ISR) is the gradual re-narrowing of a stented coronary artery lesion, due to subsequent tissue proliferation at the stented site.
In-Stent Restenosis (ISR) is observed in about 10 per cent of patients who undergo a Drug Eluting Stent (DES) implantation and also, in more that 30 per cent of patients who undergo bare-metal stent (BMS) implantation.
Such patients, who come back with reclogging of the coronary arteries following an earlier procedure of a bare metal or a drug-eluting stent implant, are candidates for treatment with the MagicTouch.
The unique drug delivery technology is designed to deliver sub-micron particles of Sirolimus which are encapsulated in a biocompatible drug carrier. The drug and carrier reach the inner layers of the vessel walls and act as a reservoir for long-term release of Sirolimus.
It has been treated more than 25,000 people in the global markets.
The MagicTouch sirolimus coated balloon has received the breakthrough device designation from the US Food and drug administration (FDA).