Concept Medical said yesterday that it received CE Mark approval for three versions of its MagicTouch sirolimus-coated balloons.
The MagicTouch PTA for peripheral artery disease, MagicTouch ED for erectile dysfunction and MagicTouch AVF for arterio-venous fistula and graft all received approval in Europe, according to a news release.
Concept Medical said MagicTouch PTA is the only commercially available and CE Marked sirolimus-coated balloon for PAD. MagicTouch PTA is used in percutaneous transluminal angioplasty for opening blocked blood vessels.
MagicTouch ED is also the only DCB of its kind commercially available for therapeutic management of erectile dysfunction, according to Concept Medical.
The Tampa, Fla.-based company said it plans to intensify efforts to market and promote the MagicTouch products in Europe and other relevant markets.
The MagicTouch AVF won breakthrough device designation from the FDA in August, just a few weeks after the MagicTouch DCBs for below-the-knee use received the same nod. MagicTouch for the treatment of coronary in-stent restenosis won breakthrough designation in May.