Endomag Receives CE Mark Approval for Minimally Invasive Breast Cancer Surgery Marker

Endomag Receives CE Mark Approval for Minimally Invasive Breast Cancer Surgery Marker

Medical device developer Endomag has recently received CE Mark approval for Magseed, its minimally invasive breast marker used to guide surgeons during breast cancer surgery.

Magseed will be distributed in Europe by Sysmex, a global laboratory diagnostics and healthcare company, as part of a new five-year distribution agreement for the Sentimag surgical guidance platform.

Breast cancer patients with small, non-palpable breast tumors often undergo complex procedures to determine the tumor’s exact location before surgery. With Endomag’s technology, these patients can access a less-invasive alternative, since the device works as a magnetic surgical guidance probe that detects tumors.

The U.S. Food and Drug Administration (FDA) approved the combined Magseed and Sentimag platform in April 2016. Magseed is the magnetic marker that allows a radiologist to accurately mark the tumor site with a seed smaller than a grain of rice, up to 30 days before surgery. Once implanted, it’s set firmly in place and cannot be dislodged before surgery. The patient can go home and carry out regular daily activities.

Sentimag is a platform that sends audio-visual cues to surgeons to detect the marker during surgery. This frees the surgeon from having to select the best approach, reduces the surgery’s invasiveness, and possibly provides a better cosmetic outcome.

Sentimag was approved by the European Commission (EC) in 2010, but in combination with the Sienna magnetic nanoparticle tracer, another Endomag product.

“After the successful launch of Magseed in the US, where many of the top cancer centres are now using it routinely, we couldn’t wait to make it available across Europe,” Eric Mayes, Endomag’s chief executive officer, said in a press release. “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 localisation and sentinel node biopsy using a single instrument.”

We are delighted with this opportunity to introduce Magseed. We will now be able to deliver a safer, more efficient workflow for cancer centres that we believe will help them be more efficient and more effective. This is perfectly in line with our mission of shaping the advancement of healthcare for the benefit of patients and our clients alike,” added Ines Groener, senior vice president of oncology at Sysmex.

The official launch of Endomag’s technology in Europe will happen at the Oncoplastic and Reconstructive Breast Surgery (ORBS) conference in Nottingham, Sept. 25-27.

CE Mark approval is a seal of approval issued by the European Commission that means products have been assessed to meet pre-established safety, health, and environmental protection requirements. CE Marking also supports fair competition by holding all companies accountable to the same rules.

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