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news.SenoRx has received clearance from the FDA to modify a warning on its Contura Multi-Lumen Radiation Balloon Catheter product label. The revised warning clarifies the use of the Contura MLB in cases in which there is less than five millimeters of skin spacing.
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The revised warning will now read as follows: “The breast cavity must be imaged before implantation to ensure the applicator will fit appropriately. Do not use if the cavity is too small. Do not use if the balloon surface to skin surface distance is less than five millimeters, unless the maximum skin dose is less than or equal to 145% of the prescription dose. Use of the appropriate off-set lumen(s) should be used to minimize the exposure to the skin.”
Contura MLB Catheter is used for delivering radiation to the tissue surrounding the lumpectomy cavity following surgery for breast cancer. For appropriate patients, Contura MLB is one of a new class of devices which is said to reduce treatment time to five days from six to eight weeks. SenoRx believes that the Contura MLB may play an important role in the shift from traditional whole breast radiation therapy to localized partial breast radiation therapy.
Lloyd Malchow, president and CEO of SenoRx, said: “We believe that the modified Contura MLB product labeling helps to clarify the appropriate use of the device. The off-set lumen design is a clear competitive advantage for Contura MLB.”