Spectranetics Receives Clearance for Larger-Diameter AngioSculpt Scoring Balloon

June 24, 2015—Spectranetics Corporation announced that it has received US Food and Drug Administration 510(k) clearance for its AngioSculpt percutaneous transluminal angioplasty scoring balloon catheter in 7- and 8-mm-diameter balloon sizes, which are suitable for treating narrowing native or synthetic fistulas.

Noting that approximately half of all patients who undergo balloon angioplasty will return with recurrent hemodialysis access dysfunction within 6 months, Spectranetics stated that the AngioSculpt device in 7- and 8-mm diameters will be able to assist physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty.

In addition to hemodialysis access patients, AngioSculpt catheters with 7- and 8-mm diameters are also appropriately sized to prepare highly calcified lesions in the iliac and superficial femoral arteries. With the device’s lower inflation pressures, the larger-diameter AngioSculpt device provides a safe approach to preparing the vessel for optimal stent placement, advised the company.

In Spectranetics’ press release, George Mueller, MD, commented, “In spite of advances in medical device technology, maintaining hemodialysis access function remains a difficult challenge. The AngioSculpt scoring balloon catheter, 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.” Dr. Mueller is with Bethesda Hospital in Boynton Beach, Florida.