SenoRx, Inc., an Aliso Viejo, California firm, is in the business of designing and developing so-called Multi-Lumen Radiation Balloon (MLB) catheters, devices for delivering radiation to the tissue surrounding the lumpectomy cavity following surgery for breast CA. The firm has just received a 510(k) clearance from the FDA for its second Contura™ MLB radiation balloon design.
Some patients who are potential candidates for balloon therapy are currently excluded because of the location of the lesion and their breast size. Contura’s advanced multi-lumen design may address this issue for certain patients. In addition, the Contura MLB uses vacuum to remove excess seroma and air to enhance conformance of often irregularly shaped lumpectomy cavity walls to the balloon surface in order to deliver precise radiation dosing through multiple radiation source lumens.
“The novel proprietary design of our newest Contura Multi-Lumen Radiation Balloon (MLB) Catheter allows the clinician greater flexibility in appropriately fitting the lumpectomy cavity with a balloon catheter,” said Lloyd Malchow, SenoRx President and Chief Executive Officer. “The new-size Contura balloon may be appropriate for approximately 10 to15 percent 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 4 to 5 centimeters in diameter, while the new balloon can be used for larger lumpectomy cavities ranging from 5 to 6 centimeters in diameter.”
Press release: SenoRx Receives Additional 510(k) Clearance for Its Contura MLB…
Product page: Contura …
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