Covidien plc has gained 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).
Two drug coated balloon PAD approvals in one week. First it was Medtronic’s announcement that it had gained FDA’s nod for its IN.PACT device for use in the vessels of the upper leg. Now Covidien, soon to be under the same roof, has gained CE mark approval for its Stellarex™ device. The relevance of this approval lies in the fact that the Stellarex platform will be sold off on completion of the Medtronic/Covidien transaction, to Spectranetics Corporation.
“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,” said Dr. Henrik Schröeder, radiologist, Vascular Center-Jewish Hospital, Berlin, Germany, and principal investigator, ILLUMENATE FIH Study. “In clinical trials, the Stellarex™ DCB has demonstrated promising results with strong patency rates and low reoccurrence of target lesions at 24 months.”
Source: Business Wire