Irvine, CA - SenoRx, Inc. recently announced expanded labeling for its larger-size Contura 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.
"The novel proprietary design of our new Contura Shape Select 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 MLB
SenoRx originally received 510(k) clearance from the U.S. Food and Drug Administration on May 23, 2007 for Contura 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.
SOURCE: SenoRx, Inc.