THE EASIEST WAY TO TREAT
SYMPTOMATIC FIBROADENOMAS
Fibroadenoma is the most common form of benign breast tumors, experienced by as many as 10% of women.
Unlike cancerous tumors, a fibroadenoma moves under the skin when touched. It may be diagnosed by means of breast examination and ultrasound imaging, but if diagnosis is uncertain, the patient may also undergo a mammogram, core biopsy, and/or fine needle aspiration.
WHEN DOES A PATIENT
SEEK TREATMENT?
PAIN OR DISCOMFORT
ANXIETY
ENLARGING MASS
COSMETIC CONCERNS
PHYSICAL DEFORMITY
CRYOABLATION STANDARD OF CARE
Cryotherapy offers a minimally invasive treatment with optimal cosmetic outcomes. The ProSense™ system also enables the fibroadenoma patient to undergo in-office cryoablation treatment that is effective, painless, and faster than other procedures.
AMERICAN SOCIETY
OF BREAST
SURGEONS
(ASBrS) AFFIRMS*:
Cryoablation: “… 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.”
* Consensus Statement for Management of
Fibroadenomas of the Breast
PROSENSE™ IS DEFINING THE GOLD STANDARD IN FIBROADENOMA TREATMENT
Treating fibroadenomas successfully since
clinical trials began in 2012
- No breast tissue is removed
- In-office, immediate, safe, effective, and durable ablation
- Rapid cryoablation (treatment time: 5-15 minutes)
- No sutures required
- Cosmetically superior results – no cavity for hematoma formation or volume loss
- Simple technique, ultrasound-guided
- Painless; freezing temperatures function as analgesic
- Liquid nitrogen in easy-to-store thermos-sized containers
- Small disposable probes; minimal office waste
- Existing code (CPT 19105) for in-office treatment of breast fibroadenoma
CLINICAL SUPPORT
University Hospital Tübingen, Germany | Lead investigator: Dr. Markus Hahn1
ProSense™ “proved functional and safe, while showing meaningful reduction in volume, palpability, [and] pain” caused by the fibroadenoma in the treated patients.
96%
of patients and physicians rated cosmetic results as excellent or good
75%
SMALLER
At 12 months, the average volume of the cryoablated zone was reduced by 75%, indicating the fibroadenoma was destroyed and being reabsorbed.
1. Hahn, M & Pavlista, D & Danes, J & Klein, R & Golatta, M & Harcos, A & Wallwiener, D & Gruber, I. Ultrasound Guided Cryoablation of Fibroadenomas. Ultraschall in der Medizin (Stuttgart, Germany : 1980). 2012. n.p. http://www.biomedsearch.com/nih/Ultrasound-Guided-Cryoablation-Fibroadenomas/23143883.html