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|Spectranetics Corporation is incorporated under the laws of Delaware and formed in 1984. The Company develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Company has two operating segments that are identified on a geographic basis: (1) U.S. Medical and (2) International Medical. U.S. Medical and International Medical offer the same products and services but operate in different geographic regions, have different distribution networks and different regulatory environments. Its products are used to treat arterial blockages in the heart and legs and to remove pacemaker and defibrillator cardiac leads. Approximately 66% of its disposable product revenue is from products used in connection with its proprietary excimer laser system, the CVX-300®. Its single-use laser catheters contain up to 250 small diameters, flexible optical fibers that can access difficult to reach peripheral and coronary anatomy and produce evenly distributed laser energy at the tip of the catheter for more uniform ablation. Its disposable products are focused in two categories: Vascular Intervention (VI) and Lead Management (LM). Vascular Intervention products include; 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, drug delivery catheters for vascular delivery of drugs and diagnostic agents. Lead Management products include: excimer laser sheaths; non-laser sheaths; and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads. Its competitors are manufacturers of products used in competing therapies within the peripheral and coronary atherectomy markets, such as: atherectomy and thrombectomy, using mechanical methods to remove arterial blockages, balloon angioplasty and stents, specialty balloon angioplasty, bypass surgery and amputation. The Company’s products are medical devices subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act, or FDCA. FDA regulations govern.|
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