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Noticias
COLORADO SPRINGS, Colo., July 9, 2014 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced that its wholly-owned subsidiary, AngioScore, Inc., developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, launched its new 200 mm length AngioSculpt® PTA Scoring Balloon Catheters for the treatment of Peripheral Artery Disease (PAD) above-the-knee (ATK).
The new AngioSculpt catheters received U.S. Food and Drug Administration (FDA) 510(k) clearance to be marketed for the dilatation of lesions in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. They are not approved for use in the coronary or neuro-vasculature.
The catheters incorporate 200 mm balloons in diameters of 4.0, 5.0 and 6.0 mm with a novel scoring element specifically designed for these longer balloons. The devices are expected to be particularly useful in treating the typical complex and long lesions found above-the-knee.
'These new longer scoring balloons extend the capability of the AngioSculpt in treating the most challenging femoro-popliteal lesions safely and efficiently and will be a very important addition to the armamentarium of physicians treating complex endovascular disease,' said Nelson L. Bernardo, MD, medical director of the Peripheral Vascular Laboratory, MedStar Heart Institute, MedStar Washington Hospital Center.
The AngioSculpt balloon catheter was developed by AngioScore, Inc., which was acquired June 30, 2014, by The Spectranetics Corporation. Scott Drake, President and CEO of Spectranetics states that, 'We are proud to introduce a viable new product to treat PAD so quickly following the joining of our two companies. At Spectranetics, we focus on solutions for the sickest and trickiest patient population. Now, united with AngioScore, we continue our commitment to provide solutions to cross, prep and treat the most complex morphologies associated with coronary and peripheral diseases.'
Thomas R. Trotter, president of Spectranetics' AngioScore subsidiary, added, 'The treatment of PAD is a rapidly growing segment of the interventional cardiovascular market. Worldwide, over 1 million percutaneous peripheral endovascular procedures are performed annually, and the PAD market continues to demonstrate significant growth due to improved diagnosis and the increasing prevalence of important risk factors such as adult onset diabetes mellitus. We believe that the AngioSculpt line of scoring balloon catheters is particularly useful in treating this very challenging and serious disease.'