November 21, 2016—The Spectranetics Corporation announced that the company’s Stellarex 0.014-inch drug-coated balloon (DCB) has received European CE Mark approval.
The Stellarex 0.014-inch device is designed to treat small vessels, below-the-knee disease, and critical limb ischemia. The combination of the currently available Stellarex 0.035-inch and the new 0.014-inch option available in Europe expands Spectranetics’ portfolio of next-generation DCBs to treat complex disease states across the lower extremities, stated the company.
Prof. Dierk Scheinert, MD, of Universitätsklinikum in Leipzig, Germany, commented in Spectranetics’ announcement, “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.”
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