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COLORADO SPRINGS, Colo., Jan. 29, 2013 (GLOBE NEWSWIRE) -- The Spectranetics Corporation today announced regulatory and reimbursement approval by Japan's Ministry of Health, Labour and Welfare (MHLW) for its Quick-Cross
® Support Catheter for peripheral interventions. This approval enables a limited launch in targeted hospitals, followed by full launch later in 2013. Other products in the family, the Quick-Cross Extreme, Quick-Cross Select and additional product sizes have been or will be submitted for MHLW review later this year.
The Quick-Cross family of support catheters was FDA-approved in 2004 -- the first guidewire support catheter to receive FDA approval – and is the recognized market leader in the United States. The device is used to direct and support a guidewire access to vasculature during interventional treatment of peripheral artery disease (PAD) and Critical Limb Ischemia (CLI). The Quick-Cross' low-profile tapered tip eases the crossing of complex and challenging lesions, tracking effectively through the twists and bends of the peripheral vasculature. Crossing total occlusions requires robust guidewire support, and Quick-Cross is the first choice of many physicians for these complex lesions.
PAD is a condition that causes blood vessels, predominantly in the legs, to become restricted or blocked. Left untreated, it can ultimately result in non-healing wounds on the legs and feet, gangrene and even amputation. Smoking and diabetes are primary contributors to the incidence of PAD and CLI. Disease prevalence combined with Japan's healthcare system makes this one of the most attractive markets in the world.
Spectranetics currently distributes SLS
® II Laser Sheaths, LLD
® Lead Locking Devices, and ELCA
® Coronary Laser Atherectomy Catheters in Japan. The approval of Quick-Cross represents Spectranetics' first step into the peripheral intervention market. With its Japanese distributor partner DVx, Inc., Spectranetics continues to expand market access to its broader portfolio of Vascular Intervention and Lead Management products.
"We've had tremendous growth in Japan with our lead management and coronary atherectomy product lines. Entering peripheral artery disease with Quick-Cross in the world's second largest medical device market is a key element of our global expansion strategy," stated Scott Drake, CEO of Spectranetics.