IN.PACT Admiral drug eluting balloon receives CE mark approval for hemodialysis access in patients with end-stage renal disease- Medtronic

Medtronic announced that the IN.PACT Admiral drug eluting balloon (DEB) (also known as the IN.PACT Admiral drug-coated balloon (DCB) in non-European markets) has received CE (Conformit� Europ�ene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. The IN.PACT Admiral drug-coated balloon (DCB) is a clinically-proven, cost-effective primary endovascular therapy that enables physicians to treat claudication, restenosis and alleviate pain from superficial femoral artery (SFA) disease. The DCB's primary mode of action is physical dilatation of the vessel lumen by percutaneous transluminal angioplasty (PTA), and the proven paclitaxel drug is intended to prevent artery narrowing by minimizing scar tissue formation.

IN.PACT Admiral DCB received the CE (Conformit� Europ�ene) Mark in 2009 to treat peripheral artery disease (PAD) and approval by the U.S. Food & Drug Administration in December 2014 to treat superficial femoral and popliteal arteries.