Endomag marker receives new FDA clearance
Endomag, the Cambridge-based surgical guidance company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to extend the indication of its Magseed® magnetic marker to include both the marking of soft tissue and long-term implantation.
The Magseed marker has already been used in thousands of lesion localisations for breast cancer.
This FDA clearance makes it the world’s only wire-free localisation device that can be implanted into any soft tissue with no restrictions on the length of time that the marker can remain in the body.
Magseed is a tiny magnetic seed, smaller than a grain of rice, that can be detected using the Sentimag® probe. In order to support its extended indication, the Magseed marker was evaluated in a number of soft-tissue models including lymph nodes, lung and thyroid tissue.
The Magseed marker is at least 60 per cent smaller than competing non-radioactive localisation devices and is made from low-nickel stainless steel. It’s safe to be imaged under ultrasound, X-ray and can be safely scanned with MRI under indicated conditions.
Crucially for radiologists and surgeons, the Magseed marker cannot be broken on deployment, following implantation, or damaged with electrocautery during surgery.
Eric Mayes, CEO at Endomag, said: “Our team’s ability to innovate for the benefit of clinicians and their patients continues to strengthen, and it’s great to be able to deliver another world first with this extended indication for Magseed.”
Endomag’s Sentimag platform and its surgical markers, Magseed and Sienna, are designed to guide the accurate removal of cancer, while helping to maximise the amount of healthy tissue retained.
These products have been used in over 30,000 tissue localisations at more than 300 hospitals. The Sentimag system continues to increase its global footprint, with regulatory approvals in Europe, the US, Canada, the Middle East, Africa, Australia, New Zealand, Singapore, and Hong Kong.
• PHOTOGRAPH SHOWS: Eric Mayes