Magseed, a minimally invasive breast marker for cancer localization during surgery receives clearance in Europe

Endomag, a surgical guidance company received CE clearance for Sentimag+Magseed breast cancer diagnostic system, that guides surgeon for precise location of impalpable tumor during breast lumpectomy. It improves outcome and reduces the amount of radioactive exposure for patients.

As breast cancer screening techniques increases, the tumors are now detected at very early stages, when they are smaller, difficult to locate and less well defined. Nearly 50% of all tumors are not palpable at diagnosis and also not well delineated during the surgery.

Magseed allows for precise localization of lump during surgery. It is placed in place by radiologist under mammo or tomo guidance, it is smaller than a grain of rice, takes only minutes for placement and cannot be dislodged from the site for 30 days. The patient can go on with her life with no discomfort.

On the day of surgery, the surgeon uses the Sentimag to accurately locate the tumor before making an incision thereby ensuring complete removal of tumor, better cosmetic outcome and less surgical time. Sentimag is essentially a highly sensitive magnetometer that is able to spot the implanted Magseed without exposing patient to radiations.

X-ray showing a complete surgical specimen with negative margins and Magseed™ in the centre, next to the cancer.

The Magseed is safe in MRI environments and can also be spotted by USG.

Traditional guide wires, which were inserted by a radiologist in earlier times, are source of constant discomfort as they protrude from a patient's breast restricting the patient to the hospital. In 25%  of cases they are displaced before performing  surgery which calls for additional follow up surgeries as the cancerous tissue is left behind.

In USA, the Magseed device was FDA 510(k) cleared in March 2016 and since been adopted across many hospitals.

“Magseed –Safety and feasibility study of the use of magnetic marker seeds to localize breast cancers” was published in May 2017 in European Journal of Surgical Oncology (EJSO).

Eric Mayes, CEO Endomag: “After the successful launch of Magseed in the US, where many of the top cancer centers are now using it routinely, we couldn’t wait to make it available across Europe. Sysmex’s experience with the Sentimag and Sienna system makes it an ideal partner for Magseed, and Sysmex has demonstrated its ability to successfully launch and grow sales of our products across the EMEA region. Together, we can now offer the first radiation-free surgical guidance platform for both lesion localization and sentinel node biopsy using a single instrument.”

The Sentimag+ Magseed system has been installed in 130 hospitals across EMEA countries and been used in over 25,000 breast cancer operations.

                               Here is a video about Magseed.