News | Drug-Eluting Balloons | December 06, 2016

Spectranetics Receives CE Mark for Stellarex 0.014-inch Drug-Coated Balloon

Device provides additional treatment option for small vessels, below-the-knee disease and challenging critical limb ischemia

Spectranetics, Stellarex 0.014-inch DCB, CE Mark

December 6, 2016 — The Spectranetics Corp. announced in late November that its Stellarex 0.014-inch drug-coated angioplasty balloon (DCB) has received the CE mark. The device is designed to treat small vessels, below-the-knee disease and challenging critical limb ischemia (CLI) in patients. 

The combination of the currently available Stellarex 0.035-inch and the new 0.014-inch line available in Europe expands Spectranetics’ comprehensive portfolio of next-generation DCBs to treat complex disease states across the lower extremities.

CLI afflicts over 3 million people in the United States and Europe. The critical unmet need of this complex patient population is inhibition of restenosis, which commonly occurs within three to six months of treatment and can lead to high rates of non-wound healing, re-intervention and amputation.

"Now available on a 0.014-inch balloon platform, Stellarex represents a latest-generation DCB backed by compelling evidence in the fem-pop arteries. It holds strong promise to deliver safety and efficacy in the notoriously challenging infrapopliteal district,” said Prof. Dierk Scheinert of Universitätsklinikum in Leipzig, Germany.

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