FDA OKs EnVisio Surgical Navigation System for Breast Tumor Removal

Elucent Medical, a company dedicated to developing better pathways for breast cancer care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the clinical use of the company’s EnVisio Surgical Navigation System.
 
Placed at the time of the breast biopsy, Elucent Medical’s permanently implantable wireless SmartClip Soft Tissue Marker provides an alternative to painful and costly localization procedures, in which the standard approach is to place a hook-wire in the breast to identify the location of the tissue to be removed. The SmartClip is used by surgeons with the company’s EnVisio Navigation System to identify the location of the malignancy and to wirelessly navigate to it in real-time 3D. The system can uniquely identify three different SmartClip Soft Tissue Markers – allowing physicians to effectively mark difficult lesions and navigate distances, depths, and directions – removing any clinical need for hook-wire solutions.
 
Elucent Medical was co-founded by Lee G. Wilke, M.D., Professor of Surgery and Director of the University of Wisconsin-Madison Health Breast Center. The company partnered with several leading breast surgeons across the country during the design and development of its solution.
 
“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 Dr. Wilke. “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.”
 
“Our vision is to disrupt the standard of care for women who receive localization prior to their lumpectomy as part of their breast cancer treatment,” said co-founder and CEO Laura King. “Today we take a significant step toward achieving this goal. The EnVisio Navigation System and SmartClip Soft Tissue Markers will provide patients and surgeons with a wire-free, minimally invasive alternative for pre-surgical planning and navigation throughout surgery.”