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Fibroadenoma Cryoablation - Summary of Sanarus Clinical Studies

The benefits of a minimally invasive, office-based alternative to treat breast fibroadenomas have been validated both in the clinical literature and in physician adoption across the country, endorsing cryoablation as the preferred treatment.

The Visica^® Treatment System received clearance from the FDA on October 1, 2001. Initial safety and feasibility of the procedure was reported in 2002.¹ Twelve (12) month follow up on that patient group was reported in 2004.² Long-term follow up (> 2 years) was reported in 2005 on a subset of these patients.³ Among the results of the long-term follow-up study were the following:

69% of cryoablated fibroadenomas ≤ 2 cm were non-palpable within 6 months
84% of cryoablated fibroadenomas were non-palpable or softer/less prominent at 12 months
97% of patients and 100% of physicians were satisfied with the results at 2.6 years
No reports of fibroadenoma regrowth were reported

The FACT Registry

The Fibroadenoma Cryoablation Treatment (FACT) registry was established in 2003 to validate results of earlier studies and systematically demonstrate the feasibility, safety and efficacy of cryoablation over a range of treatment centers outside of a strict study protocol. Two studies have been published from the FACT Registry.

The 2004 Interim Report validated the results of earlier studies and concluded that cryoablation offered an excellent safety profile, cosmesis and patient satisfaction.⁴
The 2005 FACT Report, which included larger participation (55 institutions) and outcomes at longer intervals (6 and 12 month follow-up) concluded that cryoablation is a cost-effective, safe and effective treatment option, with low morbidity and excellent cosmesis.⁵

ASBS consensus statement

In 2005, the American Society of Breast Surgeons (ASBS), issued an Official Consensus Statement regarding fibroadenoma cryoablation:

“Several multi-institutional trials have demonstrated cryoablation to be a successful option for the resolution of fibroadenomas without surgical excision. The FDA has approved the use of cryoablation as a safe and effective therapy for fibroadenomas. Results of cryoablation have been followed out to 4 years and demonstrate the procedure to be safe, efficacious and durable.”⁶

The Visica 2™ Treatment System

The Visica 2 System was approved by the FDA in 2007 and is currently in use throughout the U.S. In 2007, the AMA awarded a Level I CPT code for the “Cryosurgical Ablation of Fibroadenoma,” substantiating the clinical and economic benefits of cryoablation as an important treatment alternative for symptomatic fibroadenomas.

Long term (4 year) data is available

For additional patient outcome data, please contact Sanarus.

References

1.) Kaufman, C., Bachman, B., Littrup, P., et. al., “Office-Based Ultrasound-Guided Cryoablation of Breast Fibroadenomas,” The American Journal of Surgery, 2002, (184), 394-400.

2.) Kaufman, C., Littrup, P., Freeman-Gibb, L., et al., “Office-Based Cryoablation of Breast Fibroadenomas: 12-Month Follow-up,” Journal of the American College of Surgeons, 2004:198 (6), 914-923.

3.) Kaufman, C., Littrup, P., Freeman-Gibb, L., “Office Based Cryoablation of Breast Fibroadenomas with Long-Term Follow-up,” The Breast Journal, 2005, (11), 344-350.

4.) Edwards, M., Broadwater, R., Tafra, L., et al., “Progressive Adoption of Cryoablative Therapy for Breast Fibroadenoma in Community Practice,” The American Journal of Surgery, 2004, (188), 221-224.

5.) Nurko, J., Mabry, C., Whitworth, P., “Interim results from the FibroAdenoma Cryoablation Treatment Registry,” The American Journal of Surgery, 2005, (190), 647-652.