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news.SenoRx has received 510(k) clearance from the FDA for a second Contura multi-lumen radiation balloon short-term breast radiation balloon design.
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Lloyd Malchow, SenoRx president and CEO, said: “The novel proprietary design of our newest Contura multi-lumen radiation balloon catheter allows the clinician greater flexibility in appropriately fitting the lumpectomy cavity with a balloon catheter. The new-size Contura balloon may be appropriate for approximately 10 to 15% of patients where a larger balloon is warranted and will allow us to compete for these cases.
“The product is currently being evaluated at several clinical sites and is expected to become generally available during the third quarter of 2008. The original Contura is four to five centimeters in diameter, while the new balloon can be used for larger lumpectomy cavities ranging from five to six centimeters in diameter.”