Spectranetics Receives CE for Drug-Coated Balloon

The Spectranetics Corporation announced that its Stellarex™ 0.014” Drug-coated Angioplasty Balloon (DCB) has received the CE mark. The Stellarex 0.014” 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” and the new 0.014” 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” 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 Professor Dierk Scheinert of Universitätsklinikum in Leipzig, Germany.

President and CEO Scott Drake stated, “Spectranetics is committed to providing specialized 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” DCB is a significant advancement in our effort to eradicate restenosis and amputation.”

Source: Spectranetics Corporation


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