CRYOABLATION
TECHNOLOGY
Next Generation
of Cryotherapy Products
The Next Generation
of Galil Medical Cryotherapy for Breast Fibroadenoma
There is a growing interest in minimally
invasive treatments for benign breast tumors,
initiated by both patients and healthcare professionals.
As an alternative to conventional surgical removal
for benign breast fibroadenomas, cryotherapy ablation
offers a minimally invasive, short 30 minute procedure
with minimal to no scarring. Furthermore, cryotherapy
requires only local anesthesia whereas conventional
surgical excisions involve conscious sedation.
About five years ago, the U.S. Food & Drug Administration (FDA) approved cryoablation as a treatment for biopsy-proven breast fibroadenomas. Recommendations by the American Society of Breast Surgeons specify that the tumor must be sonographically visible, should be less than 3 cm in diameter, and that diagnosis has to be histologically confirmed for cryosurgical treatment.
Fibroadenoma (FA) is the most common benign breast tumor with about 750,000 cases in the US, and about 500,000 cases in Europe annually, and are commonly found in women between the ages of 15 and 30. Watchful waiting or surgical excision has been the traditional treatment for fibroadenomas.
Minimally invasive techniques as alternative to surgical removal of benign breast tumors include vacuum assisted biopsy and various ablation technologies, including FDA-cleared cryoablation as well as investigational technologies such as Radiofrequency (RF) ablation and high-intensity focused ultrasound (HIFU).
Breast fibroadenoma cryoablation, an image-guided and minimally invasive procedure, is performed with ultra-thin needles inserted percutaneously in the breast directly to the benign tumor. The tip of the cryoablation needle is cooled to sub-zero temperatures to create an iceball. The Cryosurgical ablation of breast fibroadenoma can be performed as an office or outpatient procedure with standard ultrasound for direct observation and monitoring of the procedure.
The cryosurgery
(freezing) itself acts as an anesthetic, so patients
remain awake and are given only local anesthesia
to numb the breast. As compared to other ablation
treatments, the cryo procedure results in minimal
pain.
Galil Medical is currently conducting a postmarket study in the U.S. on using cryoablation for the treatment of fibroadenoma.
Breast Fibroadenoma Cryoablation Benefits
Cryoablation provides several benefits for breast surgeons and breast radiologists aiming to provide a minimally invasive option to their patients for treating breast fibroadenoma:
• Simple office procedure
• Local anesthesia
• High degree of precision
• Standard ultrasound monitoring and control
• Excellent cosmetic results
• No scarring
• Treatment can be repeated
The Galil Medical SeedNet™
System and 17-gauge
disposable cryoablation needles have FDA clearance
for the treatment of benign fibroadenoma.
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