ALISO VIEJO, Calif., May 5, 2008 (PRIME NEWSWIRE) -- SenoRx, Inc. (Nasdaq:SENO) today announced that it has received clearance to modify a warning on its Contura(tm) Multi-Lumen Radiation Balloon (MLB) Catheter product label from the U.S. Food and Drug Administration. The revised warning clarifies the use of the Contura MLB in cases in which there is less than 5 millimeters of skin spacing.
The original applicable label warning read:
"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 5 mm."
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 5 mm, 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."
"We believe that the modified Contura MLB product labeling helps to clarify the appropriate use of the device," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "The off-set lumen design is a clear competitive advantage for Contura MLB."
About Contura(tm) MLB
SenoRx received 510(k) clearance from the U.S. Food and Drug Administration on May 23, 2007 for Contura(tm), its Multi-Lumen Radiation Balloon (MLB) Catheter 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 can 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. Some patients who are presently 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. SenoRx has been granted three patents related either to the design or manufacturing of Contura MLB. The first uses of Contura MLB took place in late June 2007.
About SenoRx
SenoRx (Nasdaq:SENO) develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis and treatment of breast cancer, including its EnCor(r) vacuum-assisted breast biopsy system and Contura(tm) MLB catheter for delivering radiation to the tissue surrounding the lumpectomy cavity following surgery for breast cancer. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. In addition, SenoRx has recently launched several of its products through distributors in more than 15 countries outside the U.S. and Canada. The company's line of breast care products includes biopsy disposables, biopsy capital equipment, diagnostic adjunct products and therapeutic disposables. SenoRx is developing additional minimally invasive products for the diagnosis and treatment of breast cancer. For more information, visit the company's website at www.senorx.com.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning the expected use and competitive advantage of Contura MLB are forward-looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause SenoRx's actual results to differ materially from the statements contained herein. Information on potential risk factors that could affect SenoRx's business and its financial results are detailed in its most recent annual report on Form 10-K for the year ended December 31, 2007, as filed with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial performance, which speaks only as of the date they are made. SenoRx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.