HydroMARK in rigid applicator - Marker, lesion localization, implantable

Intended purpose

To mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes; be visible under ultrasound for at least 6 weeks; and be permanently visible by x-ray and MRI.

Functional description

The HydroMARK Breast Biopsy Site Marker is made of a resorbable hydrogel that expands with fluid and is then resorbed. The hydrogel material is visible under ultrasound. Embedded in the hydrogel is a coiled metallic wire made of stainless steel or titanium that will be permanently visible under x-ray and MRI when the hydrogel is resorbed. The marker is supplied pre-loaded in a rigid applicator.