Spectranetics receives 510(k) clearance for larger diameter AngioSculpt scoring balloon


Spectranetics has received US Food and Drug Administration 510(k) clearance for the AngioSculpt percutaneous transluminal angioplasty (PTA) scoring balloon catheter in 7mm and 8mm diameter balloon sizes, designed to treat the narrowing of the native or synthetic fistula.

Approximately half of all patients who undergo balloon angioplasty will return with recurrent haemodialysis access dysfunction within six months. Spectranetics says that the AngioSculpt PTA scoring balloon catheter in assists physicians with a difficult patient set, targeting lesions in the haemodialysis access that are resistant to standard balloon angioplasty.

“In spite of advances in medical device technology, maintaining haemodialysis access function remains a difficult challenge,” stated George Mueller, Bethesda Hospital in Boynton Beach, USA. “AngioSculpt, now in sizes appropriate for a larger range of vessel diameters, has the potential to address the most difficult problems we encounter in treating arteriovenous access dysfunction. The product provides the power physicians need, partnered with a controlled dilatation that reduces dissection rates and trauma to the vessel. Physicians who frequently treat these patients are hopeful that adoption of the new tool will demonstrate that it not only preserves, but extends the life of an access.”

In addition to the haemodialysis access market, AngioSculpt is also appropriately sized to prepare highly calcified lesions in the iliac and superficial femoral arteries, according to a company press release. These lesions traditionally challenge routine stent placement. Due to the product’s lower inflation pressures, the larger diameter AngioSculpt provides a safe approach to preparing the vessel for optimal stent placement.

“This is a large market with ample opportunity to improve patient outcomes with superior technology, combining precision, power and safety,” states Kim Bridges, senior vice president of sales and marketing, Vascular Intervention, Spectranetics.