CRYOABLATION
TECHNOLOGY
Next Generation
of Cryotherapy Products
The Next Generation
of Galil Medical Cryotherapy for Uterine Fibroids
Galil Medical’s innovative cryosurgical
ablation treatments have been widely used
by urologists worldwide for prostate and kidney
cancer. Building upon this success, the company's
next generation of cryotherapy applications are
aimed toward developing minimally invasive procedures
for the Women's Health market.
This treatment is considered
experimental and is not available in the United
States.
Cryotherapy
(also called Cryosurgery or Cryoablation) is a
new and promising minimally invasive surgery which
may prove to provide an alternative to hysterectomy
for symptomatic uterine fibroids.
Uterine fibroids (benign tumors of the uterus) are the most common tumors of the female genital tract and when symptomatic require treatment. Every woman's experience is different and symptoms may include heavy periods, anemia, pelvic pressure, and frequent urination. It is estimated that 30% of the 600,000 hysterectomies performed annually in the United States are related to fibroids.
The surgical treatment of choice for symptomatic fibroids is hysterectomy. In recent years, there has been an increased demand for uterus preserving treatments even among women who do not wish to maintain fertility. There are studies underway to evaluate the use of different endometrial ablation techniques, originally developed for menorrhagia treatment, and being applied to fibroids. These technologies include rollerball ablation, microwave endometrial ablation, thermal balloon endometrial ablation (TBEA), and hydro thermal ablation.
Uterine-preserving hysterectomy alternatives currently available include myomectomy, myolysis, uterine artery embolization (UAE) also referred to as uterine fibroid embolization (UFE), MR guided focused ultrasound (MRgFUS), and cryo.
Cryomyolysis is an image-guided
uterine
fibroid treatment. Ultra-thin cryoablation
needles are inserted percutaneously, with no incision,
directly into the fibroid under direct laparoscopic
visualization. The cryoablation system operates
by applying the Joule-Thomson effect in which
high pressure Argon gas is expended inside a very
thin, 17-gauge
cryoablation needle to produce cooling.
The tip of the cryoablation needle is cooled to sub-zero temperatures to create an iceball. These iceballs combine to create a targeted freezing zone to freeze and destroy the fibroid. Real-time ultrasound monitors the iceball formation and ice coverage of the fibroid.
Clinical Outcomes
Galil Medical conducted a pilot study at three centers to evaluate Percutaneous Laparoscopically Assisted Cryomyolysis (PLC) of symptomatic uterine fibroids in premenopausal women using 17-gauge cryoablation needles.
The PLC treatment was followed-up at 6 and 12 months. Follow-up sonography measured fibroid volume shrinkage. Relief of symptoms attributable to uterine fibroids (bleeding patterns, pelvic discomfort/pain/pressure, urinary frequency, constipation, pedal edema, etc.), as well as patient's well being were documented using a validated Quality of Life questionnaire. (Spies et al., 2002).
Median fibroid volume reduction was
47% and 63% at 6 and 12 months respectively. Median
SSS-UFS-QoL score improvement was 59% and 67%
at 6 and 12 months respectively. Additionally,
based on interviews, patients experienced marked
improvement of bleeding and bulk symptoms. One-year
data indicates that PLC provides significant fibroid
shrinkage, symptom relief, and enhanced quality
of life for patients with symptomatic uterine
fibroids.
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