BiomarC Restore is a sterile, pyrogen-free, single-use fiducial marker specifically designed for placement in the surgical bed following breast tumourectomy.
BiomarC Restore integrates two complementary components:
- Pyrolytic carbon-coated zirconium oxide marker (BiomarC ENH®) in the centre of the sphere.
Visible on kV X-rays, CT, CBCT, mammography, ultrasound andmagnetic resonance imaging (MRI). - Lyophilised glucan gel matrix, which acts as a temporary filler, adapting to the surgical cavity and promoting organised tissue regeneration.
This gel is gradually reabsorbed over a period of 6 to 8 weeks,
promoting organised tissue regeneration.
After resorption, the BiomarC® Enh marker remains in the centre of the cavity, ensuring a stable and accurate long-term anatomical reference for radiotherapy.
It can be combined with other BiomarC SECURE suturable fiducial markers to perfectly mark the surgical site once the lumpectomy has been performed.
PRODUCT
BiomarC® Restore provides a precise anatomical reference point, assisting in optimal planning and administration of radiotherapy treatment. Its design promotes not only radiotherapy precision, but also natural aesthetic recovery, particularly useful in patients with small breasts or complex anatomical areas.
APPROVAL
It received CE marking and FDA approval in 2021. The results of clinical studies revealed that the tissue at the implant site was
macroscopically normal and the structural integrity of the products was maintained.
MORPHOLOGY
Oval configuration measuring 2x3x3cm or 3x3x4cm, designed to anatomically adapt to the surgical bed. It includes the BiomarC® Enh marker (1x 5 mm) made of zirconium oxide coated with pyrolytic carbon (density 5.68 g/cm³), which guarantees its stability and visibility over time.
