Ireland-based healthcare company Covidien has obtained CE mark approval for its Stellarex drug-coated angioplasty balloon (DCB).
The Stellarex DCB has been developed to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease (PAD).
Germany-based Vascular Center-Jewish Hospital radiologist and Illumenate FIH study principal investigator Dr Henrik Schröeder said: "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."
According to Covidien, Stellarex DCB is inserted into the diseased artery and inflated to open the vessel and restore blood flow, while a drug paclitaxel is deposited onto the vessel wall to prevent the reoccurrence of new blockages.
Stellarex DCB features EnduraCoat technology that helps in reducing drug loss during transit and facilitates efficient drug delivery to the treatment site.
Spectranetics has signed an agreement with Covidien to acquire Stellarex DCB platform, and is subject to the closure of the pending acquisition of Covidien by Medtronic that is expected to take place in early 2015.
Image: Covidien’s manufacturing facility in Athlone, Ireland. Photo: courtesy of Covidien plc.