FDA clears AngioScore's balloon catheter for renal indications
This article was originally published in Clinica
AngioScore can now market its AngioSculpt percutaneous transluminal angioplasty (PTA) scoring balloon catheter for dilating lesions in renal arteries. The US FDA has granted 510(k) approval for this new indication – the device had previously been cleared for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (www.clinica.co.uk, 16 May 2008). The Fremont, California firm believes that AngioSculpt will be particularly useful in treating renal artery stenotic disease.