Covidien Stellarex drug-coated angioplasty balloon receives CE mark to treat peripheral arterial disease patients


Covidien has announced that it has received CE mark approval for its Stellarex drug-coated angioplasty balloon. The Stellarex drug-coated angioplasty balloon is used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease.

The Stellarex drug-coated angioplasty balloon 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 drug-coated angioplasty balloon’s proprietary EnduraCoat technology provides a durable, uniform coating which reduces drug loss during transit and facilitates efficient drug delivery to the treatment site.

“Peripheral arterial disease is a progressive disease that affects millions of people around the world. Drug-coated angioplasty balloons are emerging as an alternative to traditional treatment options, such as angioplasty or stenting, because of their ability to restore blood flow, prevent the reoccurrence of new blockages and preserve future treatment options,” says Henrik Schröeder, radiologist, Vascular Center-Jewish Hospital, Berlin, Germany, and principal investigator, ILLUMENATE FIH study. “In clinical trials, the Stellarex drug-coated angioplasty balloon has demonstrated promising results with strong patency rates and low reoccurrence of target lesions at 24 months.”

The 24 month results of the ILLUMENATE First-in-Human (FIH) study demonstrated a primary patency rate of 80.3%. Additionally, the study showed 87.9% freedom from target lesion revascularisation at 12 months and 85.8% at 24 months.

On 2 November, 2014, Covidien announced it had entered into a definitive agreement with Spectranetics Corporation under which Spectranetics will acquire Covidien’s Stellarex drug-coated angioplasty balloon platform. The transaction is subject to the closure of the pending acquisition of Covidien by Medtronic, which is expected to occur in early 2015.