Spectranetics Nabs CE Mark for Stellarex 0.014” Drug-Coated Balloon
Published: Nov 22, 2016
COLORADO SPRINGS, Colo., Nov. 21, 2016 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (NASDAQ:SPNC) today 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.”
The Spectranetics Corporation develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are available in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.
The Company's Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee, the AngioSculpt scoring balloon used in both peripheral and coronary procedures, and the Stellarex drug-coated balloon peripheral angioplasty platform, which received European CE mark approval in December 2014. Stellarex is not available for sale in the United States. The Company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.
The Lead Management (LM) product line includes excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.
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