FDA News

FDA clears scoring balloon catheters with larger diameter

Spectranetics recently announced that it has received FDA 510(k) clearance for a scoring balloon catheter in diameters of 7 mm and 8 mm to treat a narrowed fistula during hemodialysis in patients with coronary or peripheral artery disease, according to a press release.

The AngioSculpt Percutaneous Transluminal Angioplasty Scoring Balloon Catheter (Spectranetics) is intended to treat a difficult patient population with lesions that are resistant to standard balloon angioplasty. The approved diameter sizes are also appropriate for the preparation of highly calcified lesions in the iliac and superficial femoral arteries, which can be challenging for routine stent placement, according to the release.

"In spite of advances in medical device technology, maintaining hemodialysis access function remains a difficult challenge," George Mueller, MD, of Bethesda Hospital in Boynton Beach, Florida, said in the release. "The AngioSculpt Scoring Balloon Catheter … has the potential to address the most difficult problems we encounter in treating [arteriovenous] access dysfunction.”

Disclosure: Cardiology Today was unable to obtain relevant financial disclosures.

Spectranetics recently announced that it has received FDA 510(k) clearance for a scoring balloon catheter in diameters of 7 mm and 8 mm to treat a narrowed fistula during hemodialysis in patients with coronary or peripheral artery disease, according to a press release.

The AngioSculpt Percutaneous Transluminal Angioplasty Scoring Balloon Catheter (Spectranetics) is intended to treat a difficult patient population with lesions that are resistant to standard balloon angioplasty. The approved diameter sizes are also appropriate for the preparation of highly calcified lesions in the iliac and superficial femoral arteries, which can be challenging for routine stent placement, according to the release.

"In spite of advances in medical device technology, maintaining hemodialysis access function remains a difficult challenge," George Mueller, MD, of Bethesda Hospital in Boynton Beach, Florida, said in the release. "The AngioSculpt Scoring Balloon Catheter … has the potential to address the most difficult problems we encounter in treating [arteriovenous] access dysfunction.”

Disclosure: Cardiology Today was unable to obtain relevant financial disclosures.