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

Traditional practice has involved excisional biopsy or lumpectomy to remove the fibroadenoma, requiring hospitalization, anesthesia, scarring and extended recovery time.

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.

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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

PROSENSETM 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 US 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%

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