DRUG COATED BALLOONS FOR PERIPHERAL VESSELS AND A-V ACCESS
Following the success and promising clinical results of coronary MagicTouch, in the fall of 2019 company Concept Medical introduced MagicTouch PTA and MagicTouch AVF, market first CE approved Sirolimus coated DEB’s, dedicated to peripheral vessels and treatment of a-v access.
This has special significance because of recent discussions about the safety of Paclitaxel coated devices. Regardless of the final conclusion on Paclitaxel safety, to have a device with another anti- proliferative drug option, which proved to be clinically superior in coronary DES trials, surely represents welcome and valued addition for peripheral endovascular treatment.
Proprietary NANOLUTE technology ensures drug binding on the balloon and fast drug transfer to the tissue, as well as drug retention. Preclinical trials done by dr. Renu Virmani proving that Sirolimus is present in the vessel tissue 14 days post inflation in sufficient therapeutic doses. At the same time systemic drug loss is minimal. Additionally, the drug tissue presence is noted all the way up to adventitial layer.
NANOLUTE technology combines nanotechnology, in scaling down the drug and carrier particle size to nano-level in order to ensure drug uptake to the tissue, with special type of carrier which is helping to overcome low lipophilicity of Sirolimus as a limiting factor for successful drug binding on the balloon and transfer to the lesion.
Magic Touch AVF
Magic Touch PTA 0.014″
Magic Touch PTA 0.018″
The benefit of Sirolimus (or limus group) as an anti-proliferative drug compared to Paclitaxel is well known and documented in several DES trials. Main benefits include cytostatic mode of action (compared to cytotoxic of Paclitaxel) and better anti-restenotic effect.
Due to NANOLUTE coating technology the deliverability of MagicTouch is excellent and compares to regular PTA catheters.