Spectranetics gets CE mark for Stellarex 0.014” drug-coated balloon

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Stellarex 035″ drug-coated balloon

Spectranetics has announced that its Stellarex 0.014” drug-coated angioplasty balloon has received the CE mark. The device is designed to treat small vessels, below-the knee disease, and challenging critical limb ischemia in patients.

The combination of the currently available Stellarex 0.035”and the new 0.014” line available in Europe expands Spectranetics’ comprehensive portfolio of next generation drug-coated balloons to treat complex disease states across the lower extremities. “Now available on a 0.014” balloon platform, Stellarex represents a latest generation drug-coated balloon backed by compelling evidence in the femoropopliteal arteries. It holds strong promise to deliver safety and efficacy in the notoriously challenging infrapopliteal district,” said Dierk Scheinert of Universitätsklinikum in Leipzig, Germany.

Spectranetics president and chief executive officer Scott Drake states, “Spectranetics is committed to providing specialised and innovative tools and compelling clinical data to improve our patients’ quality of life. Stellarex 0.014” exemplifies these important elements and augments our existing product portfolio, which now includes clinically differentiated treatment for both above and below-the-knee disease. The Stellarex 0.014” drug-coated balloon is a significant advancement in our effort to eradicate restenosis and amputation.”