Tag: concept medical
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)...
Concept Medical granted IDE approval for Magic Touch sirolimus DCB below...
The Magic Touch percutaneous transluminal angioplasty (PTA) sirolimus drug-coated balloon catheter (DCB) has received investigational device exemption (IDE) for the treatment of below-the-knee (BTK) atherosclerotic...
First patients enrolled in LIMES randomised trial of Magic Touch sirolimus-coated...
Concept Medical has announced the initiation of the LIMES trial, which has enrolled 15 patients to evaluate the safety and efficacy of the company's...
Interventional News’ top 10 most popular items of February 2022
The February top 10 features news of the recent Japanese randomised control trial results, which support the use of mechanical thrombectomy in ischaemic stroke...
SIRONA head-to-head randomised trial achieves 50% enrolment
Concept Medical recently announced that the SIRONA randomised controlled trial (RCT; Head-to-head comparison of sirolimus versus paclitaxel drug-eluting balloon angioplasty in the femoropopliteal artery)...
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)...
Concept Medical releases status updates on SIRONA RCT
Concept Medical has released a series of status updates on their head-to-head SIRONA (Sirolimus versus paclitaxel drug-eluting balloon angioplasty in femoropopliteal diseases) randomised controlled...
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)...
