AngioScore Introduces New Scoring Balloon Catheters

Colorado Springs, Colo.-based Spectranetics Corporation’s subsidiary, AngioScore Inc. has released its new 200 mm length Angiosculpt PTA Scoring Balloon Catheters for the treatment of peripheral artery disease (PAD) above the knee.

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, 5 and 6 mm with a 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, M.D., 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 Spectranetics.

“We are proud to introduce a viable new product to treat PAD so quickly following the joining of our two companies,” said Scott Drake, president and CEO of Spectranetics. “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.”

“The treatment of PAD is a rapidly growing segment of the interventional cardiovascular market,” added Thomas R. Trotter, president AngioScore. “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.”

According to the Mayo Clinic, PAD is a common circulatory problem in which narrowed arteries reduce blood flow to the limbs. PAD prevents extremities—usually the legs—from receiving enough blood flow. Symptoms include leg pain, especially when walking. It is also likely to be a sign of a more widespread accumulation of fatty deposits in the arteries (atherosclerosis). This condition may be reducing blood flow to the heart and brain, as well as the legs.

Spectranetics makes single-use medical devices used in minimally invasive procedures within the cardiovascular system.