Frequently Asked Questions
What is it?
The Visica® Procedure is a minimally invasive cryoablation procedure for the treatment of breast disease. The Visica® 2 Treatment System is an image-guided device that freezes the tumor, thereby destroying it and preventing regrowth. This breast-conserving technique offers patients a non-surgical alternative to lumpectomy and is available at participating breast centers nationwide.
What is cryoablation?
Cryoablation refers to procedures that use extremely cold temperatures to destroy diseased tissue, including cancer cells. Liquid nitrogen or argon gas is the freezing agent. Cryoablation was initially used to ablate skin lesions, but its applications have expanded to treat cancers of the breast, prostate, liver, lung and kidney, as well as certain cancers that have metastasized. It is also referred to as percutaneous cryoablation or cryotherapy.
Is cryoablation a new technology?
No. Cryoablation has been used in open or laparoscopic surgical procedures for over 50 years. Today, cryoablation is routinely done percutaneously (through the skin) with small incisions and under image-guidance i.e., ultrasound, CT or MRI. Cryoablation causes tissue necrosis by freezing the targeted tissue and damaging the microvasculature structure that feeds the cells.
Is there clinical data to support the use of cryoablation for treatment of breast cancer?
Yes. In a 5-year multicenter study funded by the National Cancer Institute and sponsored by the Alliance for Clinical Trials in Oncology, cryoablation with the Visica 2 Treatment System was shown to be 100% effective for complete ablation of invasive ductal breast cancer tumors <1.0 cm. Results from this breast cancer study, which included a 5-year follow-up, were published in the Annals of Surgical Oncology. The Visica 2 Treatment System was the exclusive device used in the Z1072 study and showed cryoablation effective in 92% of the targeted lesions (Simmons, 2016)1.
What is the long-term follow-up data post cryoablation?
Long-term follow up data has been evaluated in many clinical studies of cryoablation. In the Z1072 Clinical Trial, 99 patients were evaluated with a 5 year follow up. All cases were deemed successful with no recurrence of early stage breast cancer. Dr. Cary Kaufman evaluated long-term follow-up of more than 3 years which demonstrated that the vast majority of palpable tumors become non-palpable, with almost complete resolution of the lesion as observed by ultrasound after cryoablation (Kaufman, 2005)2.
Is there clinical data of recurrence rates post cryoablation?
Yes, there is clinical data of recurrence rates post cryoablation. Dr. E Fukuma treated over 58 breast cancer tumors with cryoablation between 2006-2012. Median follow up time was 48 months and no loco-regional or distant metastases were found (Fukuma, 2016)3. Dr. Peter Littrup evaluated 11 patients with a mean breast tumor of 1.7 cm in 2009. Follow-up time was 18-month follow up and no recurrences were found and there was a 95% volume reduction in the tumors (Littrup, 2009)4.
How is cryoablation with the Visica® 2 Treatment System performed?
The breast is numbed with local anesthesia. The physician inserts a hollow-tipped probe through a small incision and inserts it into the tumor under ultrasound guidance. Closed-loop liquid nitrogen passes through the probe and forms an ice ball around the lesion. Damage to healthy surrounding tissue is minimal. Freezing destroys the tumor cells, which are then gradually reabsorbed and expelled by the body over 3-18 months. At no point and time does liquid nitrogen enter the body.
How long does the procedure take?
The procedure is performed in a doctor’s office and takes less than 30 minutes. Most patients report minimal discomfort and are able to resume normal activity right away. Since no breast tissue is removed, the shape of the breast is maintained and little, if any, visible scarring occurs.
Are other treatment modalities still available post cryoablation?
Yes. Cryoablation does not restrict you from future treatment options if needed. Patients still have the option to undergo other treatment modalities after cryoablation if the physician requires it. Procedures such as lumpectomy, mastectomy, chemotherapy and radiation and other ablative modalities are still available.
- Simmons R, et al, A Phase 2 Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072, Ann Surg Oncol (2016) 23: 2438. doi:10.1245/s10434-016-5275-3.
- Kaufman C, et al, Office based cryoablation of breast fibroadenomas with long term follow-up. The Breast Journal 11:344-350, 2005.
- Fukuma E, data presented by D. Holmes, Cryoablation: Alternative to Conventional Surgery and Radiotherapy in the Management of Early Stage Invasive Breast Cancer, presented at Synergy Miami, 2016.
- Littrup PJ, et al, Cryotherapy for breast cancer: a feasibility study without excision. J Vasc Interv Radiol 2009; 20:1329–1341