::: SenoRx ::: Marking

For Patients: After the biopsy procedure, your physician may place a very small marker in the middle of the biopsy area. If your biopsy specimen is found to be positive, the marker will enable your doctor to precisely re-locate the biopsy site for further excision of tissue.

Ideally, needle localization would occur in the operating room while the patient is under anesthesia. This would prevent vasovagal reactions, and would increase both radiology and operating room efficiencies. However, this is not possible if the lesion is partially or completely removed at the time of the biopsy and if traditional x-ray-visible markers are used. Under these conditions, the patient would be taken to radiology prior to surgery, to find and localize the lesion.

To enable the surgeon to readily locate the lesion and place the needle in the operating room, SenoRx pioneered the concept of an ultrasound-visible marker that serves as a surrogate for the lesion. Using a portable ultrasound machine to locate the ultrasound-visible marker, the surgeon can decide the optimum approach for excising the lesion for the best cosmetic result.

Gel Mark^® Ultra markers provide excellent ultrasound visibility. In a recent registry trial involving 45 general surgeons and 432 patients, Gel Mark Ultra markers demonstrated a significant reduction in the frequency of positive margins. Of the 41 patients whose lesions were localized with ultrasound, and margin status was available, clear margins were achieved in 37 (90%). These results are superior to the rates of positive margins reported in the literature, which range from 12% to 56%, p < 0.01. (“Surgical Benefits Conveyed by Biopsy Site Marking System Using Ultrasound Localization”, American Society of Breast Surgeons, 2005)

For both core-needle and vacuum-assisted biopsy devices, the Gel Mark product line offers a versatile range of options to meet the surgeon’s imaging preferences. Four distinctly shaped wireforms enable the surgeon to mark multiple lesions in the same breast. Plus, the surgeon has a choice of two ultrasound-visible pellet materials. The original Gel Mark porcine gelatin pellets provide short-term ultrasound visibility, while Gel Mark Ultra PLA/PGA pellets ensure extended visibility.

Gel Mark is ideal for long-term visualization under mammography or MRI. Gel Mark’s porcine gelatin post-biopsy volume aids in placement accuracy and long-term marker stability. Porcine gelatin also provides 10-14 days of ultrasound visibility.

Gel Mark Ultra offers long-term visualization with mammography or MRI. Gel Mark Ultra’s PLA/PGA pellets provide four to six weeks of ultrasound visibility, thereby allowing needle localization to be performed using ultrasound

Gel Mark UltraCor is the first 14 gauge marking system for core-needle biopsy devices that features ultrasound-visible pellets and a permanent marker for long-term visualization with mammography and MRI. UltraCor enables you to precisely mark masses for mammographic-sonographic correlation, for comparison to follow-up films, for unequivocal pre-operative localization and specimen excision, and to assure a residual target after neoadjuvant therapy.

Gel Mark UltraCor MRI is designed specifically for marking suspicious lesions in an MRI setting. The UltraCor MRI deploys PLA/PGA granules for ultrasound visualization. UltraCor MRI lets you mark the lesion in the MRI suite and then easily target it at a later time using ultrasound or stereo in the comfort of the physician office. A tissue specimen can then be harvested utilizing standard biopsy technique and equipment.

SenoMark contains absorbent PGA mesh pads with a permanent wireform for long-term visualization with mammography or MRI. The PGA mesh provides excellent midrange ultrasound visibility.

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