The Spectranetics Corporation has announced that its wholly-owned subsidiary, AngioScore, launched its new 200mm length AngioSculpt PTA scoring balloon catheters for the treatment of peripheral artery disease above-the-knee.
The new AngioSculpt catheters received US 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 200mm balloons in diameters of 4.0, 5.0 and 6.0mm 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,” says Nelson L Bernardo, medical director of the Peripheral Vascular Laboratory, MedStar Heart Institute, MedStar Washington Hospital Center.
The AngioSculpt balloon catheter was developed by AngioScore, which was acquired 30 June, 2014, by The Spectranetics Corporation. Scott Drake, president and chief executive officer of Spectranetics states, “We are proud to introduce a viable new product to treat peripheral arterial disease 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.”