Irish healthcare firm Covidien has secured CE Mark for its Stellarex drug-coated angioplasty balloon (DCB), designed to restore and maintain blood flow to arteries in the the leg in patients with peripheral arterial disease (PAD).
The company said the 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 reoccurrence of new blockages.
Stellarex DCB features EnduraCoat technology that helps reduce drug loss during transit and facilitates efficient drug delivery to the treatment site.
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."
The CE Mark is based on 24 month results of the ILLUMENATE First-in-Human (FIH) study, which showed a primary patency rate (ability to keep the artery open to restore blood flow) of 80.3%.
In addition, the trial also showed 87.9% freedom from target lesion revascularisation at 12 months and 85.8% at 24 months.
In November 2014, Spectranetics signed an agreement with Covidien to acquire Stellarex DCB platform. The deal is subject to closure of the pending acquisition of Covidien by Medtronic that is expected to take place in early 2015.