Tag: concept medical
Can sirolimus-coated balloons overcome current treatment challenges for chronic limb-threatening ischaemia...
Eric Secemsky (Boston, USA) and Edward Choke (Singapore) discuss the role of sirolimus-coated balloons in the treatment of peripheral arterial disease (PAD), particularly below...
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...
Concept Medical’s SIRONA trial completes enrolment
Concept Medical has announced the completion of patient enrolment in the SIRONA trial. According to the company, this is the world's first and the...
Sirolimus-coated balloon a “clear alternative” to paclitaxel-coated balloons
Ulf Teichgräber (Jena, Germany) and Edward Choke (Singapore) discuss—at the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK)—some of the key benefits...
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...
Vascular News’ top 10 most popular stories of February 2022
February's top 10 includes a consensus statement from the Society for Vascular Surgery (SVS) and the Enhanced Recovery after Surgery (ERAS) Society on perioperative...
SIRONA head-to-head randomised trial achieves 50% enrolment
Concept Medical recently announced that the SIRONA randomised controlled trial (RCT)—a head-to-head comparison of sirolimus versus paclitaxel drug-eluting balloon angioplasty in the femoropopliteal artery—has...
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 provides update on IMPRESSION trial to evaluate MagicTouch AVF
Concept Medical has provided an update on the progress of the IMPRESSION (Sirolimus-coated balloon angioplasty versus plain balloon angioplasty in the treatment of dialysis...
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 balloon...
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 breakthrough device designation for use in...
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)...
US$60 million raised to fund sirolimus-coated balloon investigational trial
Concept Medical Inc. has approached the FDA for an investigational device exemption (IDE) for their sirolimus-coated balloon (DCB). To support this process, they have...
