Breast cancer patients in the U.S. will have a new surgical option that eliminates exposure to radioactive materials and offers a less invasive, more flexible alternative for cancer detection. Receiving FDA approval in April and a distribution deal this month, the new device will be used to locate early stage tumors that cannot yet be felt.
Co-invented by University of Houston physicist Audrius Brazdeikis and his collaborators at the University College of London, the Sentimag technology platform is a magnetic surgical guidance probe used with nanoparticle tracers and other magnetic devices to more safely and easily determine the spread of cancer. Its first introduction commercially in the U.S. will be its use with an implantable magnetic lesion marker, called Magseed, that easily guides surgeons to cancerous lesions. The Sentimag+Magseed combination serves as a replacement for procedures involving surgical wire needles and radioactive seeds, which are the two standards of care currently in practice for finding a breast tumor in advance of a lumpectomy.
Receiving 510(k) clearance from the U.S. Food and Drug Administration (FDA) in April, the Sentimag+Magseed breast cancer diagnostic system can now be marketed stateside. Thanks to the distribution deal unveiled this month between Devicor Medical Products and Endomag, a UH spinoff medical devices company co-founded by Brazdeikis, the technology will be immediately available for use here in the U.S. Devicor Medical Products, a division of Leica Biosystems, will be the exclusive distributor of Sentimag in the U.S. and Canada.
As breast cancer screening programs have advanced, tumors are now detected much earlier, so they are smaller, less defined and harder to feel. In fact, 50 percent of all breast tumors cannot be felt at diagnosis. Since these small tumors are often impalpable, they are difficult for surgeons to locate during a lumpectomy.
“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. “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.”
Traditional guide wires, which are inserted by a radiologist in a separate procedure prior to a patient’s lumpectomy, protrude from a patient’s breast, leading to potential discomfort and restricting the patient to the hospital. More critically, the protruding guide wires risk movement prior to surgery, requiring follow-up surgery in up to 55 percent of lumpectomy procedures. Conversely, Magseed is similar in size to a grain of rice and placed within the tumor, allowing the possibility for patients to return home before their operations. During the lumpectomy, the Magseed magnetic marker is located using audio-visual cues from the Sentimag device.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.