Magseed Approval Extended in Europe for Soft Tissues, Long-Term Implantation

Magseed Approval Extended in Europe for Soft Tissues, Long-Term Implantation

Magseed, a small magnetic marker by Endomag designed to accurately mark the site of cancer cells before surgery, is now approved in Europe for use in any soft tissue and for long-term implantation, the company said.

Magseed was previously approved to guide surgeons during breast cancer surgery, and could only be implanted up to 30 days before surgery. The European Medicines Agency approval extends its use to other tissues, including lymph nodes, lung, and thyroid tissue, and removes the restrictions on the length of time the marker can remain in the body.

This extension follows a similar decision by the U.S. Food and Drug Administration (FDA) in February 2018, also clearing Magseed for additional tissues and longer implantation time.

“Ever since we launched the Magseed marker, we have been asked by European physicians if they can use it to mark a variety of different cancer sites in the body, which also require a longer implantation than the 30 days we had in Europe,” Eric Mayes, CEO at Endomag, said in a press release. “We received this expanded indication from the FDA last year, and I’m delighted that Endomag is the first to offer this same level of targeted treatment to European cancer patients.”

An increasing number of women with breast cancer are being treated with chemotherapy prior to surgery to help reduce tumor size. However, this makes it hard to determine at the point of surgery whether the cancer has spread to other tissues, which occurs once cancer cells reach the lymph nodes.

Magseed has been approved to mark and help surgeons remove small, non-palpable breast tumors, replacing the traditional guide wires and radioactive seeds. Those often cause discomfort, require same-day surgery, and can sometimes be dislodged.

With the new indication, Magseed can be used in breast cancer patients to mark suspicious lymph nodes before chemotherapy occurs. Used in combination with Magtrace, the minimally invasive marker will help surgeons achieve a more targeted dissection of lymph nodes, and to assess whether the cancer has spread.

Magtrace is a liquid, magnetic and non-radioactive tracer which follows a similar path through the lymphatic system that a spreading cancer cell would. This allows surgeons to determine which lymph nodes might be affected by breast cancer cells.

Once implanted, Magseed sits firmly in place and cannot be dislodged before surgery. The magnetic marker is then detected by placing Sentimag — a handheld magnetic probe — on the patient’s skin near the tumor site. The system will give visual and audio signals when it detects Magtrace particles, allowing researchers to locate the lymph nodes into which a tumor drains.

“We have been using Magseed for two years and have performed over a thousand surgeries with the technology,” said Abigail Caudle, associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston. “The ability to mark lymph nodes and ensure we remove the cancerous node to examine them closely is a huge advantage for patients, because we spare them extensive and unnecessary axillary surgery.”

Results from two independent studies conducted by Caudle and Heather Greenwood of the University of California, San Francisco indicated that the Magseed marker can easily and accurately mark positive lymph nodes, resulting in a 100% retrieval success.

“When it comes to marking lymph nodes in patients receiving neo-adjuvant chemotherapy, there are very few options — wires are notoriously difficult to place and can easily migrate, often resulting in multiple lymph nodes being removed but not the one you necessarily wanted to take,” said James Harvey, consultant oncoplastic breast surgeon at the Wythenshawe Hospital, Manchester University NHS Foundation Trust.

“It’s a huge step forward that we can now use the Magseed marker to mark lymph nodes across Europe, which will allow us to offer our patients more targeted surgery and accurate staging,” he said.