Covidien's Stellarex DCB Is Approved in Europe

January 8, 2015—Covidien announced it has received European CE Mark approval for the Stellarex drug-coated angioplasty balloon (DCB), which is used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease (PAD).

The paclitaxel-coated Stellarex DCB uses the company’s EnduraCoat technology, which the company describes as providing a durable, uniform coating that reduces drug loss during transit and facilitates efficient drug delivery to the treatment site.

According to the Covidien, the 24-month results of the ILLUMENATE First-in-Human study of the Stellarex DCB demonstrated a primary patency rate of 80.3%. Additionally, the study showed 87.9% freedom from target lesion revascularization at 12 months and 85.8% at 24 months.

In the press release announcing the approval, the study’s principal investigator, Henrik Schröeder, MD, commented, “PAD is a progressive disease that affects millions of people around the world. DCBs 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. In clinical trials, the Stellarex DCB has demonstrated promising results with strong patency rates and low reoccurrence of target lesions at 24 months.” Dr. Schröeder is a radiologist at the Vascular Center-Jewish Hospital in Berlin, Germany.

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, Inc., which is expected to occur in early 2015.