Surgical guidance company Endomag has received 510(k) clearance from the 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 and 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 compnay’s Sentimag probe. In order to support its extended indication, the marker was evaluated in a number of soft-tissue models including lymph nodes, lung and thyroid tissue. Constructed from low-nickel stainless steel, it can be safely imaged under ultrasound and by X-ray and can also be safely scanned with MRI under indicated conditions. Crucially for radiologists and surgeons, the Magseed marker cannot be broken on deployment, following implantation, or be damaged with electrocautery during surgery.
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. The products have been used in more than 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.
For further information about Endomag visit www.endomagnetics.com
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