Elucent Medical Secures FDA 510(k) Clearance for EnVisio Surgical Navigation System Combined with SmartClip Soft Tissue Marking Technology in Breast Cancer Treatment

VCBeat (WeChat Official Account: vcbeat) has learned from foreign media that medical device company Elucent Medical recently announced that its EnVisio surgical navigation system has received FDA 510(k) clearance. The system can be combined with Elucent Medical’s soft tissue marking technology, SmartClip, to replace the traditional “wire localization” approach for breast cancer treatment.

During breast biopsy, the standard approach involves placing a hookwire in the breast to localize the lesion. Elucent Medical has also permanently implanted SmartClip soft tissue markers in patients’ breasts for breast cancer treatment; however, this is undoubtedly a painful and costly method. There is an urgent market need for a breast cancer treatment approach that can localize breast lesions without using “localization hookwires” or “radioactive seeds.”

Elucent Medical has identified such an alternative solution. The company recommends that physicians use the EnVisio Surgical Navigation System in conjunction with the SmartClip implantable device during breast cancer surgery. This approach enables effective identification of malignant tumor locations and provides real-time 3D wireless navigation to the tumor site. The EnVisio Surgical Navigation System can recognize three different types of SmartClip soft tissue markers, assisting physicians in accurately marking breast lesions and navigating their length, depth, and orientation in real-time 3D, thereby replacing the “wire localization” technique for breast cancer treatment.

“This is a cost-effective solution that addresses a major challenge faced by breast surgeons: how to easily locate malignant tumors during surgery, particularly in tissues lacking anatomical landmarks,” said Dr. Lee Wilke, co-founder of Elucent Medical, in a press release. “We have developed an efficient, convenient, and precise medical system designed specifically for surgeons, which can improve clinical outcomes for physicians in specialties such as lymphatic surgery and thoracic surgery.”

Laura King, another co-founder, stated, “We aim to disrupt the standard of care that requires women to undergo localization procedures prior to lumpectomy. Today, we have taken a significant step toward achieving this goal. The EnVisio Surgical Navigation System, together with SmartClip Soft Tissue Markers, will provide patients and surgeons with a wireless, minimally invasive alternative for preoperative planning.”

Notably, Elucent Medical’s SmartClip has already been approved for market sale (restricted to sales to physicians), and the recent approval of the EnVisio system will address the drawbacks of traditional SmartClip wire localization, establishing a new standard of care for breast cancer treatment.

Elucent Medical, established in 2014, is a breast cancer treatment company based in Madison, Wisconsin, USA. The company is dedicated to raising the standard of current breast cancer care while reducing treatment costs, thereby enabling more patients to access and afford superior breast cancer therapies.

(Compiled by Wang Chan)