Stellarex DCB has CE Mark approval for treatment of PAD-Covidien

Covidien plc announced it has received CE Mark approval for its Stellarex drug-coated angioplasty balloon (DCB).The Stellarex DCB is used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease (PAD). The Stellarex DCB is inserted into the diseased artery and inflated to open the vessel and restore blood flow, while a drug called paclitaxel is deposited onto the vessel wall to prevent the reoccurrence of new blockages.

The 24 month results of the ILLUMENATE First-in-Human (FIH) study demonstrated a primary patency rate (ability to keep the artery open to restore blood flow) of 80.3 percent. Additionally, the study showed 87.9 percent freedom from target lesion revascularization at 12 months and 85.8 percent at 24 months. On November 2, 2014, Covidien announced it had entered into a definitive agreement with Spectranetics Corporation under which Spectranetics will acquire Covidien�s Stellarex DCB platform. The transaction is subject to the closure of the pending acquisition of Covidien by Medtronic, which is expected to occur in early 2015.

Comment: Companies active in this field of PAD blocker leg arteries are Medtronic- IN.PACT Admiral drug eluting balloon stent (CE MARK 2009), C.R. Bard- Lutinox 035 drug coated balloon catheter (CE MARK 2012), Cook Medical Zilver PTX paclitaxel stent for femoropopliteal disease (CE MARK 2009)- recalled in 2013 due to problems with its delivery system but not the stent itself. Cook has modified its manufacturing of the stent and it is still on the market .All FDA approved.The ShockWave Lithoplasty balloon (CE MARK 2014) delivers a form of energy making the lesion more amenable to angioplasty.