HydroMARK in flexible applicator - Marker, lesion localization, implantable

Intended purpose

To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI. 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 that will be permanently visible under x-ray and MRI when the hydrogel is resorbed. The marker is supplied pre-loaded in delivery systems designed to fit a number of probes and handpieces.

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 flexible applicator.