FDA Approved Women's Health

EnVisio Surgical Navigation System for Breast Lumpectomies Cleared in U.S.

Elucent Medical, a firm based in Eden Prairie, MN, won FDA clearance for its EnVisio Navigation System. The technology involves placing a wireless SmartClip implantable marker within the breast that identifies the location of the tissue to be removed. Normally guidewires are used to locate the target tissue, which extend out through the skin. The SmartClip marker remains completely implanted until the lumpectomy. It’s actually possible to use multiple SmartClips to target different locations within the breast, and this is aided by the fact that each of the implants has its own radiofrequency signature identifying it uniquely.

The marker provides the distance, depth, and direction information of its location to an electronic pen-like device that the surgeon uses during tumor removal. “Elucent Medical is offering a cost-effective solution that addresses a key challenge for breast surgeons: how to easily find the location of a malignant biopsy during surgery, especially in tissue that lacks anatomical landmarks,” said Elucent co-founder Lee G. Wilke, M.D., Professor of Surgery and Director of the University of Wisconsin-Madison Health Breast Center. “We developed a system designed by surgeons to be intuitive, efficient, and precise, eliminating the need for a localization procedure. We believe this innovation has the potential to improve cosmetic and clinical outcomes, with other possible applications for lymph and thoracic surgeries.”

Product page: EnVisio Navigation System…

Via: Elucent Medica


Original Article: (https://www.medgadget.com/2019/04/envisio-surgical-navigation-system-for-breast-lumpectomies-cleared-in-u-s.html)

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