Spectranetics's US-based subsidiary AngioScore has introduced its new 200mm length AngioSculpt PTA scoring balloon catheters to treat peripheral artery disease (PAD) above-the-knee (ATK).
The US Food and Drug Administration (FDA) granted 510(k) approval to the new AngioSculpt catheters to be marketed for dilatation of lesions in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, as well as to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The company said that the new catheters are not approved for use in the coronary or neuro-vasculature.
Features of the new catheters include 200mm balloons in diameters of 4mm, 5mm and 6mm with a new scoring element designed for these longer balloons.
The new devices will be particularly useful in treating the typical complex and long lesions found above-the-knee.
MedStar Washington Hospital Center's MedStar Heart Institute Peripheral Vascular Laboratory medical director Nelson Bernardo said: "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."
In June 2014, Spectranetics acquired AngioScore, developer of the AngioSculpt balloon catheter.
Spectranetics president and CEO Scott Drake said: "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."
AngioScore designs, develops, manufactures and markets scoring balloon catheters for treatment of cardiovascular and peripheral artery diseases.
The company said that more than one million percutaneous peripheral endovascular procedures are performed every year across the world.
The new AngioSculpt scoring balloon catheters represent the next generation in angioplasty balloon catheters for treatment of both coronary and peripheral artery disease.
Image: The illustration shows how PAD can affect arteries in the legs. Photo: courtesy of National Heart Lung and Blood Institute.