Concept Medical (CMI) has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its MagicTouch AVF sirolimus drug-coated balloon (DCB).
MagicTouch AVF has been approved to treat of stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure.
MagicTouch AVF sirolimus drug-coated balloon
In July this year, the company requested the FDA to provide breakthrough device designation for MagicTouch AVF.
The proposed indications for MagicTouch AVF’s breakthrough device status is for use in percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistula or graft with 4mm to 12mm diameter and up to 100mm in length.
According to the company, two types of vascular access designed for long-term use include the arteriovenous fistula (AVF) and the arteriovenous graft (AVG).
AVF is a connection designed surgically between an artery and a vein to expand the bore of the vein, while AVG is another method to connect an artery and a vein.
The company has designed Sirolimus delivery platform technology for use in Magic Touch AVF balloons to treat stenotic lesions in AVF and AVG.
In 2018, the world’s first pilot study to evaluate the safety and efficacy of Magic Touch PTA Sirolimus balloon in vascular access interventions was commenced in Singapore.
A multi-disciplinary team, under the guidance of principal investigator Dr Tan Chieh Suai, is carrying out the study in Singapore General Hospital.
Singapore General Hospital consultant vascular and endovascular surgeon and associate professor Dr Tjun Yip Tang said: “We are still in the early stage in the clinical study of drug-coated balloons for hemodialysis access patients.
“The Paclitaxel-based technology study results have certainly been encouraging, but more research is required to determine if other devices may prove to be more effective or uniquely beneficial for specific anatomical or clinical sub-type presentations.”
