Tag: MagicTouch
MagicTouch sirolimus-coated balloon granted IDE approval for treatment of the SFA
On 24 May, the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) approval for Concept Medical's MagicTouch percutaneous transluminal angioplasty (PTA)...
IMPRESSION trial assessing MagicTouch AVF passes 50% enrolment
Concept Medical has shared the latest update from its IMPRESSION (Sirolimus-coated balloon angioplasty versus plain balloon angioplasty in the treatment of dialysis access dysfunction)...
RCT investigating use of MagicTouch PTA sirolimus-coated balloon for PAD enrols...
Concept Medical has announced the enrolment of the first patient in the SirPAD (Sirolimus in peripheral arterial disease) trial. According to a press release,...
First patient enrolled in FUTURE SFA study of MagicTouch sirolimus-coated balloon
Concept Medical has announced the enrolment of the first patient in the FUTURE SFA (Randomised controlled trial of first sirolimus coated balloon versus standard...
Enrolment initiated in world’s first RCT with sirolimus-coated balloon for below-the-knee...
Concept Medical has announced the enrolment of the first patient in the FUTURE BTK (Randomised controlled trial of first sirolimus coated balloon versus standard...
Concept Medical granted CE certification for sirolimus-coated MagicTouch group of products
Concept Medical received CE certification for their MagicTouch group of products on 16 October 2019.
The CE certified products/brands are as listed below:
MagicTouch—PTA (sirolimus-coated...
MagicTouch AVF sirolimus-coated balloon granted FDA breakthrough device designation
Concept Medical has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for MagicTouch AVF, its sirolimus drug-coated balloon (DCB)...
MagicTouch PTA sirolimus coated balloon granted breakthrough device designation by FDA
Concept Medical has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus...