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Spectranetics receives US FDA 510(k) clearance for 7 and 8mm AngioSculpt Catheter

Spectranetics has received US Food and Drug Administration 510(k) clearance for the AngioSculpt PTA Scoring Balloon Catheter in 7 and 8 millimeter (mm) diameter balloon sizes.

The products are ideally suited to treat the narrowing of the native or synthetic fistula, a surgically created conduit between an artery and vein used to remove and return blood during hemodialysis.

Approximately half of all patients who undergo balloon angioplasty will return with recurrent hemodialysis access dysfunction within six months.

The AngioSculpt PTA Scoring Balloon Catheter in 7 and 8mm diameter assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty.

"In spite of advances in medical device technology, maintaining hemodialysis access function remains a difficult challenge," stated George Mueller, MD, Bethesda Hospital in Boynton Beach, Florida.

"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 AV 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 hemodialysis access market, the AngioSculpt Scoring Balloon Catheter in 7 and 8mm diameter is also appropriately sized to prepare highly calcified lesions in the iliac and superficial femoral arteries.

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.

Spectranetics senior vice-president of sales and marketing for vascular intervention Kim Bridges said: "This is a large market with ample opportunity to improve patient outcomes with superior technology, combining precision, power and safety.

"The 7 and 8 mm AngioSculpt expands the AngioSculpt product line, the number one specialty balloon in the market, and extends Spectranetics’ comprehensive portfolio to cross, prepare and treat the most complex cardiovascular conditions, now to include hemodialysis access."

About AngioSculpt Scoring Balloon Catheters
AngioSculpt Scoring Balloon Catheters represent the next generation in angioplasty balloon catheters to treat both coronary and peripheral artery disease. Their innovative nitinol scoring elements provide unique circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while minimizing "geographic miss" through their unique anti-slip properties.

AngioSculpt Scoring Balloon Catheters combine the versatility and effectiveness of a new technology with the simplicity and deliverability of traditional high-performance balloon catheters.

AngioSculpt devices have been used in over 350,000 procedures worldwide, achieving an outstanding performance record in the treatment of both coronary and peripheral artery disease.