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The Visica System is a minimally invasive cryotechnology device cleared for market by the Food and Drug Administration (FDA) for the treatment of fibroadenomas, a common benign breast condition found in at least 10 percent of all women in the United States. The procedure uses cryoablation, or extreme cold, to destroy tumors without requiring stitches or general anesthesia. The office-based procedure, which usually takes less than 30 minutes, involves placing a small needle into the center of the tumor using ultrasound guidance. The System creates very cold temperatures at the needle tip, freezing the fibroadenoma, damaging the tumor cells and causing them to break down to prevent re-growth.
Previously, surgical removal typically involved general anesthesia, a day in the hospital, an incision requiring stitches and several days of recovery. Cosmetic outcomes following surgical removal of a fibroadenoma can be troubling to patients. Because cryoablation does not involve the removal of tissue and can be performed using a small incision that does not require stitches, cosmetic outcomes are excellent.
Visica 2 provides women with a treatment option for their fibroadenomas that safely and effectively treats the lump in their breast. Even though benign, fibroadenomas can cause pain, discomfort and a great deal of anxiety. Prior to Visica 2 many women chose to live with the pain and anxiety of a lump in their breast because their only option was surgery. Now they have a simple in-office treatment that relives the pain and anxiety and treats their fibroadenoma without negative effects to the shape or size of their breast.
"We're very pleased that NI has recognized our success in developing a medical device used to treat breast tumors in a less invasive and nearly painless procedure while maintaining the design process within strict regulatory guidelines," said John F. Howe, president and Chief Executive Officer of Sanarus. "Receiving industry recognition of this caliber is a nice complement to the positive feedback we've been getting from physicians and their patients who have undergone treatment with the Visica System. Nationwide, there has been no reported fibroadenoma re-growth in more than 2,000 procedures."
More than 110 authors from 13 countries submitted papers for the Graphical System Design Achievement Awards. A judging committee of more than 30 technical publication editors and NI experts judged papers submitted across 10 application categories. In addition to the Humantarian category, the category finalists were considered for the Editors Choice, Green Engineering and the Overall Application of the Year awards. The Visica 2(TM) Treatment System also was named a finalist in the Overall Application of the Year category.
"Thanks to NI, we quickly and efficiently developed an embedded control system with a user-friendly GUI for the Visica 2 System while maintaining the highest quality, and ultimately, ensuring the safety of our customers' patients," said Randy Sullivan, Chief Operating Officer, Sanarus. "NI played a fundamental part in achieving our goals under extreme time-to-market pressure to deliver a device that would dramatically reduce the emotional and physical discomfort of patients undergoing tumor treatment. Our product design, prototype, and eventual deployment timelines were met because of the graphical system design platform from NI."
The award was presented to Sanarus by National Instruments President, CEO and Co-founder Dr. James Truchard, Co-founder and Business and Technology Fellow Jeff Kodosky and International Marketing Director Dave Wilson.
To learn more about the Graphical System Design Achievement Awards, you may visit http://www.ni.com/niweek/best.htm.
Visica 2 Treatment System
The original Visica(R) Treatment System received FDA market clearance in 2002 and has been proven highly safe and effective with more than 2,000 fibroadenomas treated. The innovative Visica 2 System has been available at select sites since April of 2007. The Visica 2 Treatment System uses liquid nitrogen as the freezing agent, obviating the need for large, high pressure tanks of argon and helium used in the original Visica Treatment System. Because nitrogen operates at colder temperatures than argon, it allows for a more efficient, faster treatment. The procedure can be completed in the physician's office, with most treatment times under 30 minutes. Early experience has shown excellent physician and patient satisfaction with the new Visica 2 Treatment System.
About Sanarus Medical
Sanarus Medical is based in Pleasanton, Calif., and is focused on providing patients and physicians with minimally invasive, office-based breast care management solutions from diagnosis and treatment to follow up. Using cryoablation technology, Sanarus has developed proprietary technologies to provide breast surgeons and radiologists with a comprehensive and minimally invasive way to diagnose and treat breast patients. The Sanarus technologies change the way that patients are managed, from an operating room-based, surgically intensive care pathway to a more comfortable, cost effective, office-based care pathway. Sanarus is dedicated to women's breast health and to providing minimally invasive solutions for the diagnosis and treatment of breast disease solutions that can help eliminate pain and improve quality of life. The company's Website is http://www.sanarus.com.
About National Instruments
National Instruments (http://www.ni.com) is transforming the way engineers and scientists design, prototype and deploy systems for measurement, automation and embedded applications. NI empowers customers with off-the-shelf software such as NI LabVIEW and modular cost-effective hardware, and sells to a broad base of more than 25,000 different companies worldwide, with no one customer representing more than 3 percent of revenue and no one industry representing more than 10 percent of revenue. Headquartered in Austin, Texas, NI has more than 4,800 employees and direct operations in nearly 40 countries. For the past nine years, FORTUNE magazine has named NI one of the 100 best companies to work for in America. Readers can obtain investment information from the company's investor relations department by calling (512) 683-5090, e-mailing nati@ni.com or visiting http://www.ni.com/nati.
LabVIEW, National Instruments, NI, ni.com and NIWeek are trademarks of National Instruments.
SOURCE Sanarus Medical
http://www.sanarus.com
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