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SenoRx's breast radiation balloon gets FDA nod

This article was originally published in Clinica

Executive Summary

SenoRx has received 510(k) clearance from the US FDA for a new version of the Contura multi-lumen radiation balloon (MLB). The device is designed to allow greater flexibility in fitting a lumpectomy cavity with a balloon catheter. The original Contura – which received US 510(k) clearance in May 2007 – is 4-5cm in diameter, while the new balloon can be used for larger lumpectomy cavities ranging from 5-6cm in diameter. Aliso Viejo, California-based SenoRx said that the new size may suit breast cancer patients in whom a larger balloon is warranted – around 10-15% of the patient population. The product is expected to become generally available during the third quarter of 2008.

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