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FDA clears AngioScore's balloon catheter for renal indications

This article was originally published in Clinica

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Executive Summary

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.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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