IRVINE, Calif., Feb. 9, 2009 (GLOBE NEWSWIRE) -- SenoRx, Inc. (Nasdaq:SENO) today announced expanded labeling for its larger-size Contura(tm) Multi-Lumen Radiation Balloon (MLB) catheter, which reflects the broader clinical capabilities included in the device's 510(k) clearance received from the U.S. Food and Drug Administration (FDA) in May 2008.
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"The novel proprietary design of our new Contura Shape Select(r) MLB provides enhanced flexibility to clinicians in appropriately fitting the lumpectomy cavity with one balloon catheter, which may be adjusted into different sizes," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "The label will now indicate Contura's suitability for lumpectomy cavities with dimensions ranging from 4.5 to 6 centimeters, compared to the previous labeling of 5 to 6 centimeters. In addition, our new Contura balloon not only offers multiple lumens for contouring the radiation dosage and flexibility in size, but also offers the ability to change shape from oval to spherical based upon inflation volumes to accommodate different sized cavities."
"The expanded labeling may allow this new Contura Shape Select MLB to fit a greater number of patients where a balloon is appropriate. This device may also make inventory management easier and less expensive for customers since it may allow them to stock a single device with the ability to accommodate a greater range of sizes. SenoRx is launching a new promotional campaign to introduce the new Contura Shape Select MLB (see attached graphic)," added Malchow.
About Contura(tm) MLB
SenoRx originally received 510(k) clearance from the U.S. Food and Drug Administration on May 23, 2007 for Contura(tm) MLB, its Multi-Lumen Radiation Balloon catheter for delivering radiation to the tissue surrounding the lumpectomy cavity following surgery for breast cancer. For appropriate patients, Contura MLB may 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 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. Contura's unique multi-lumen technology enables improved dosimetric coverage of the targeted tissue while minimizing the radiation dose to healthy tissue. SenoRx has been granted four patents related either to the design or manufacturing of Contura MLB. The first procedures using the original Contura MLB took place in late June 2007. Additionally, post 510(k) clearance, the company continues to sponsor human clinical studies to further establish the clinical profile for Contura.
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 sells several of its products through distribution partners in more than 30 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 expected usage of the product, inventory benefit gains and expense to customers 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 quarterly report on Form 10-Q, 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.
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