Breast cancer patients with small, non-palpable breast tumors often undergo complex procedures to determine the tumor’s exact location prior to a lumpectomy. Now, these patients may soon have access to less invasive, easier alternative — a newly approved device that works as a magnetic surgical guidance probe to detect tumors too small to feel.
The technology, approved by the U.S. Food and Drug Administration (FDA) in April, relies on the implantation of a magnetic lesion marker, called Magseed, into a cancerous lesion. The Sentimag technology platform then sends audiovisual cues to surgeons to detect the marker during the lumpectomy.
Through breast cancer screening programs, many tumors are now detected at early stages. In fact, about 50 percent of breast tumors now being identified are too small to feel by hand. Currently, procedures involving surgical wire needles and radioactive seeds are used to identify and locate the tumors. But traditional guide wires, requiring the insertion of a tiny needle to mark the tumor site, are often associated with discomfort, require a same-day lumpectomy, and — because they can shift —can require a follow-up lumpectomy to remove the cancer.
Magseed, similar in size to a grain of rice, allows patients to return to home prior to their surgery. The Sentimag-Magseed combination also eliminates the need to expose patients to radioactive materials and is less invasive than surgical wire needles, and may eventually replace these standard-of-care procedures, according to a press release.
The platform was co-invented by Audrius Brazdeikis, a University of Houston physicist, and colleagues at University College of London, and the collaborators set up a new company, Endomag, to commercialize the product. It will be marketed in the U.S. and Canada under a partnership between Devicor Medical Products and Endomag.
“Magseed is designed to guide surgeons using Sentimag to locate impalpable tumors for biopsy and has many advantages over wire and radioactive seed localization,” Brazdeikis said in the release. “Radiologists can place the Magseed magnetic markers up to 30 days in advance of surgery using X-ray or ultrasound guidance. This offers scheduling flexibility for surgeons and radiologists, as well as for patients, compared to wire-guided localization.”
Sentimag was approved by the European Commission in 2010, but in combination with a different Endomag product, the Sienna magnetic nanoparticle tracer. This tracer, which is used to identify the lymph nodes to which the cancer cells are drained, has already been used in more than 14,000 breast cancer procedures across Europe.