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Boston Scientific Filterwire EZ

This article was originally published in The Gray Sheet

Executive Summary

Domestic launch of next-generation embolic protection filter system for use in angioplasty and stent treatment of diseased saphenous vein grafts is announced Aug. 23 following FDA 510(k) clearance. Building on the first-generation Filterwire EX, launched in the U.S. in June 2003, the EZ debuted overseas last September featuring an updated "suspended loop" filter support design to enhance deliverability and effectiveness, Boston Scientific claims. The 510(k) was supported by the 90-patient BLAZE multi-center clinical registry. Separately, the firm reports FDA market go-ahead for its Peripheral Cutting Balloon angioplasty system. Featuring longitudinally mounted microsurgical blades, the device is intended to treat blocked hemodialysis access grafts in end-stage renal disease patients. The system requires less pressure and trauma than conventional angioplasty, the firm says...

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