January 9, 2015 — Covidien 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 Stellarex DCB’s proprietary EnduraCoat technology provides a durable, uniform coating, which reduces drug loss during transit and facilitates efficient drug delivery to the treatment site.
The 24-month results of the ILLUMENATE First-in-Human (FIH) study demonstrated a primary patency rate 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.
For more information: www.covidien.com