Spectranetics’s new, larger diameter Angiosculpt devices, percutaneous transluminal angioplasty scoring balloon catheters, have won FDA 510(k) marketing clearance, the Colorado Springs, Colo., devicemaker said Thursday.
Coming in 7 mm and 8 mm diameter balloon sizes, the products are meant to the treat the narrowing of the native or synthetic fistula, an artificially created conduit between the artery and vein used to remove and return blood during hemodialysis.
The company says that an estimated half of all patients who undergo balloon angioplasty will return in six months with recurrent hemodialysis access problems. The new catheters target lesions in the hemodialysis access site resistant to standard balloon angioplasty.
Spectranetics markets products for the treatment of arterial blockages in the heart and legs and for removal of pacemaker and defibrillator leads. — Jason Scott