Spectranetics announced that its 0.014-in. drug-coated balloon for treatment of small vessels, below-the-knee disease and critical limb ischemia has received a CE mark for use in Europe.
The DCB (Stellarex) had already received a CE mark for its 0.035-in. version for treatment of disease in femoropopliteal lesions, according to a press release from the company. Neither version has been approved for use in the United States.
The DCB can prevent restenosis, which often occurs in patients with CLI 3 months to 6 months after treatment and can lead to failure of wounds to heal, reintervention and amputation, the company stated in the release.
“Stellarex represents a latest-generation DCB backed by compelling evidence in the [femoropopliteal] arteries,” Dierk Scheinert, MD, head of the department of interventional angiology, Universitätsklinikum, Leipzig, Germany, said in the release. “It holds strong promise to deliver safety and efficacy in the notoriously challenging infrapopliteal district.”
Scheinert reports receiving research funds from Spectranetics and consulting for and/or receiving research funds from numerous other device companies.