How Wireless-Guided Localization and Precision Surgery Is Changing Breast Cancer Treatment

November 01, 2022 - Globally, breast cancer is the most common cancer among females, and more than 33% of all cases diagnosed each year are nonpalpable, meaning the tumor may be too small to feel. In 20–30% of patients with nonpalpable breast tumors, breast nodules become cancerous. Because these types of masses cannot be detected during physical examinations, healthcare providers heavily rely on medical imaging techniques, such as MRI, mammography, and ultrasound, to identify the mass for biopsy.

What Is Wire-Guided Localization?

For several decades, multi-step, wire-guided localization — also known as needle localization — has been the most widely used technique for identifying and removing nonpalpable breast tumors.

“Wire-guided localization is 1970s technology that has restrictive scheduling requirements,” Ananth Ravi, PhD, CEO and president of MOLLI Surgical and former medical physicist, told LifeSciencesIntelligence. Needle localization biopsy procedures can sometimes take up to an hour to complete and require radiology and surgical teams to work together to prevent delays.

“Breast cancer care right now is a three-legged stool involving radiology, surgery, and the patient,” explained Ravi. “For it to go well on a wire placement day, everything has to go perfectly to plan.”

Before the wire is inserted via a needle into the breast tissue, ultrasound guidance and mammogram technology help radiologists place the wire correctly for the breast cancer surgeon. Although a local anesthetic is typically used during this procedure, most patients report minimal pain and bruising but find the protruding hook-ended wire incredibly uncomfortable, Ravi described.

After the wire is placed correctly and taped to the skin, the marked mass is surgically excised and sampled for laboratory testing and microscopy analysis. Occasionally, patients feel dizzy or light-headed during the procedure, causing some to faint. Ravi shared that “if a patient is uncomfortable and faints, which is not uncommon with wire procedures, then surgery gets delayed, and the cost of surgical delays is astronomical.”

Wireless-Guided Localization

Wireless-guided localization is a precision technique that effectively decouples the radiology and surgical teams by eliminating the need for wire localization and helps surgeons effectively remove abnormal tissue while minimizing emotional and physical trauma experienced by the patient, explained Ravi. Modern nonwire devices on the market include radioactive and magnetic seeds, radar reflectors, and radiofrequency identification tags.

“Currently, MOLLI is the smallest breast tissue marker on the market — around the size of a sesame seed,” disclosed Ravi. This tiny magnetic marker, cleared by the FDA in April 2021, “makes it simpler for the patient who’s undergoing therapy, the radiologist who’s tasked with finding and marking the tumor for removal, and the surgeon who goes in and removes that tumor without causing undue cosmetic defects.”

After the MOLLI marker is placed under radiology, patients can schedule the surgical date around their own schedule instead of the surgical staff’s, creating greater flexibility for both the patient and healthcare providers. In the interview, Ravi demonstrated how the MOLLI marker is detected during the procedure.

“Surgeons use a compatible wand and tablet to guide them precisely to the location of the magnetic MOLLI marker. Then, the surgeon can use precision, down to millimeter accuracy, to figure out where the cancer is and remove it confidently,” clarified Ravi. “This is great for the patient because they know the surgeon has the tools required to remove all their cancer but also can give them the best cosmetic result.”

Cost Savings

Because this type of wire-free breast cancer surgery simplifies the procedure for patients, radiologists, and surgeons, surgical departments can perform 40% more breast surgeries and radiology departments can visit 34% more patients than wire-guided localization.

As Ravi mentioned previously, delays during wire-guided localization end up costing the patient more than time. Therefore, reducing delays during treatment translates to significant cost savings.

Clinical Diversity and Patient Outreach

As healthcare providers become more aware of the racial disparities surrounding medical devices like oral and temporal thermometers and pulse oximeters, it is vital that new medical device products are tested on various skin tones and socioeconomic backgrounds before entering the market.

The MOLLI device “benefited from being developed in Toronto, Ontario, Canada, with a public health payer system, which created a heterogeneous mix of patients within the clinical trial,” Ravi said. “Could we do better? 100% — we can always do better. Moving forward, the company will constantly advocate for accessibility. Our goal is to make MOLLI accessible to everybody, regardless of socioeconomic and racial disparities.”

Ravi graciously shared a personal and traumatic experience of his life growing up in Zambia, Africa, with LifeSciencesIntelligence: “Unfortunately, my best friend and my grandmother died within a very short period of time when I was very young. And it was that experience that illustrated to me that access to timely quality care shows the disparity between the haves and have-nots,” noting that it is hard to receive quality care in Africa without access to innovative technological advancements.

Although Ravi could not provide an expected date, his company plans to introduce MOLLI to emerging markets and expand well beyond the confines of North America.

Ergonomics and Sustainability

Ravi notes that even the design decisions associated with the device's ergonomics were tailored to its users, especially female breast surgeons, who can develop inflammatory arthritis after years of griping devices made for their male counterparts.

Aside from the smaller detection wand, the MOLLI marker device requires a mountable tablet. “The tablet was designed to be mountable at eye level so that providers are no longer craning their necks. Surgeons suffer tremendously from poor posture, leading to spinal issues,” he added.

Because performing surgery is physically demanding, other well-known risk factors that plague surgeons include multisite musculoskeletal pain, which could shorten the professional career of many.

Regarding sustainability and recovery success, “surgeons will always be able to find this magnet,” insisted Ravi. “Out of the thousands of patients who have used MOLLI, 100% of the markers were identified and localized during surgery, meaning physicians will be able to find the MOLLI marker 100% of the time.”

In addition, the MOLLI markers, wands, and tablets can be sterilized and reused to minimize waste and cost, noted Ravi.

The Future of Breast Cancer Treatment

As the FDA continues to approve new wire-free localization techniques, breast cancer treatment will increasingly become more precise and less of a burden on patients and their healthcare providers as surgeons and radiologists pivot away from traditional wire-guided methods and embrace wireless-guided localization methodologies.