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The Her Option™ Uterine Cryoblation Therapy™ System received premarket approval (PMA) on April 20, 2001. The Dysfunctional Uterine Bleeding and Uterine Fibroids- Commercial Medical Management Guideline device is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. See the following Web site for more information: http://www.fda.gov/cdrh/mda/docs/p000032.pdf. Accessed April 2009.
The Accuprobe®for use in general and plastic surgery including gynecological procedures. See the following Web site for more information: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed April 2009.
Devices for thermal ablation of the endometrium are regulated by the FDA as Class III devices that are subject to the most extensive regulations enforced by the FDA. The Gynecare ThermaChoiceTM device for thermal balloon endometrial ablation (TBEA) (Ethicon Inc.) and the Hydro ThermAblatorTM device (BEI Medical Systems) for hydrothermal endometrial ablation (HTEA) have received premarket approval from the FDA.
U.S. Food and Drug Administration (FDA) [Web site]. Searchable PMA database scanned for Product Codes MNB (Thermal endometrial ablation device) and MKN (Thermal balloon endometrial ablation device). Updated July 7, 2003.
Available at: http://www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed April 2009.
The MIRENA© received FDA approval on December 8, 2000 for use as an intrauterine contraceptive. The only indication included in the FDA-approved labeling is for use of this IUD as a contraceptive. Therefore, its use for treating dysfunctional uterine bleeding (DUB) would be considered an off-label use. The FDA does not impose restrictions on how
a licensed physician can use or prescribe an approved device. See the following Web site for more information:
http://www.fda.gov/cder/da/da1200.htm. Accessed April 2009.
The NovaSureTM Impedance Controlled Endometrial Ablation System (Novacept Inc., purchased by Pfizer Inc.) received FDA approval on September 28, 2001 for ablation of the endometrial lining of the uterus in premenopausal women with
menorrhagia secondary to DUB for whom childbearing is complete. See the following Web site for more information:
http://www.fda.gov/cdrh/pdf/p010013.html. Accessed April 2009.
A second device, the VESTA DUB endometrial ablation system was the first FDA-approved radio frequency endometrial device (Vesta Medical Inc., purchased by Pfizer Inc.). Pfizer, Inc. acquired Vesta Medical, Inc. in 1996, and clinical trial information was available until 2000. A search of the Pfizer, Inc. Web site did not identify any additional information, and there is no indication that this device is currently being marketed in the United States or Europe.
Uterine artery embolization (UAE) is a procedure and, therefore, not subject to FDA regulation. However, the embolic agents used are subject to FDA oversight. A number of agents are approved by the FDA for embolization procedures of the neurological system, but several have been specifically approved for UAE. Embosphere® Microspheres (Biosphere Medical, Inc.) received 510(k) approval on November 22, 2002, specifically for use in embolization of symptomatic uterine fibroids. Embosphere Microspheres are small spheres comprised of acrylic polymer and porcine-derived gelatin.
Although they are available in different sizes, the manufacturer states that only microspheres 500 or greater should be used for UAE. On March 26, 2004, Contour SE™ Microspheres and Contour™ Emboli PVA (Boston Scientific Corp.) also received 510(k) approval, with approved indications listed as embolization of hypervascular tumors, including leiomyoma
uteri, and arteriovenous malformations. See the following Web site for more information:
http://www.fda.gov/cdrh/pdf3/k034068.pdf. Accessed April 2009.
The Cryo-Hit(TM) System (Galil Medical Ltd.) first received 510(k) approval from the FDA on July 1, 1998. Modified versions of the device received 510(k) approval on July 12, 1999 and October 30, 2001. The device is intended for the cryosurgical destruction of tissue during gynecological procedures as well as in general, dermatological, neurosurgical, thoracic, oncological, rectal, and urological surgeries.
U.S. Food and Drug Administration (FDA) [Web site]. Center for Devices and Radiological Health (CDRH) page. 510(k)
approvals. K012497. Updated January 6, 2003. Available at:
Dysfunctional Uterine Bleeding and Uterine Fibroids- Commercial Medical Management Guideline http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed April 2009.
U.S. Food and Drug Administration (FDA) [Web site]. Center for Devices and Radiological Health (CDRH) page. 510(k)
approvals. K980913. Approval summary. Updated January 6, 2003. Available at:
http://www.fda.gov/cdrh/pdf/K980913.pdf. Accessed April 2009.
The Signa Profile/i Magnetic Resonance System (GE Medical Systems Inc.) received 510(k) approval on September 8, 1999 as an open, whole-body scanner for use in diagnostic imaging and interventional procedures performed with MRcompatible devices.
See the following Web site for more information:
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/ pmn.cfm. Accessed April 2009. (K992135) http://www.fda.gov/cdrh/pdf/K992135.pdf. Accessed April 2009 In June 2004, the Signa Excite 1.5T MR system received FDA marketing clearance to aid in diagnosis via the 510(k) process. This clearance requires system use by a physician trained in diagnostic imaging of internal structures and organs.
In October 2004, InSightec received marketing approval for the ExAblate 2000 System from FDA through the PMA process.
Research Evidence Background Abnormal uterine bleeding in women of childbearing age is defined as any change in menstrual period frequency or duration, a change in amount of flow, or any bleeding between cycles. In postmenopausal women, abnormal uterine bleeding includes vaginal bleeding 12 months or more after the cessation of menstruation, or unpredictable bleeding in patients who have been receiving hormone therapy for 12 months or more. Abnormal uterine bleeding terms include oligomenorrhea (bleeding occurs at intervals of more than 35 days), polymenorrhea (bleeding occurs at intervals of less than 21 days), menorrhagia (bleeding occurs at normal intervals but with heavy flow or duration of more than 7 days), menometrorrhagia (bleeding occurs at irregular, noncyclic intervals and with heavy flow or duration more than 7 days), and metrorrhagia (irregular bleeding occurs between ovulatory cycles) (Milliman Care Guidelines) Menorrhagia can be idiopathic or can be associated with underlying uterine lesions such as fibroids or polyps, pelvic pathology, anatomical abnormalities, systemic illness, hormonal imbalance, or certain medications. Idiopathic menorrhagia that is not related to a specific underlying condition is called dysfunctional uterine bleeding (DUB). All these conditions associated with menorrhagia can be referred to as dysfunctional uterine bleeding, although it is also possible to have some conditions such as fibroids or an anatomical abnormality with normal menses. The focus in this policy is on treatment options when the bleeding pattern is abnormal.
Uterine fibroids (also known as leiomyomata) are benign tumors of the uterus. They have a rich blood supply and may cause excessive uterine bleeding, uterine enlargement, and mass or bulk related symptoms such as pelvic pain and pressure, urinary frequency and abdominal distension.
Conservative management of DUB includes watchful waiting and pharmacological therapy. Another treatment option is dilation and curettage. Hysterectomy is available when symptoms cannot be controlled by conservative treatment.
Conservative management of symptomatic fibroids includes watchful waiting and hormonal therapy. Hormone therapy causes the fibroids to shrink; however they will quickly return to their original mass once therapy has been discontinued.
Hysterectomy has been the primary treatment for symptomatic or rapidly enlarging fibroids. Hysteroscopic removal of fibroids has been the procedure of choice for those women who want to maintain their fertility, but this is a demanding and lengthy procedure and sometimes more difficult to perform than a hysterectomy and does not prevent the recurrence of fibroids. The resulting endometrial cavity may be problematic for fertility.
Alternate minimally invasive techniques have emerged. An advantage of these procedures over hysterectomy is that they do not involve surgical removal of the uterus; therefore, the operative and recovery times are shorter and the complication Dysfunctional Uterine Bleeding and Uterine Fibroids- Commercial Medical Management Guideline rates seem to be lower. Some may be performed as outpatient procedures, avoiding the hospital stay required after hysterectomy.
Endometrial cryoablation (ECA): In this procedure, a cryoprobe introduced through the vagina under ultrasound guidance delivers extreme cold (below -15° C to -20° C) in freeze-thaw cycles to the endometrium.
Thermal balloon endometrial ablation (TBEA): In this procedure, heat is delivered to the endometrial lining of the uterus via a latex balloon is filled with a small volume of sterile dextrose and water. The temperature of the fluid is raised by a heating element to 87 degrees C resulting in thermal coagulation of 3 to 5 mm of endometrium. A variation of this technique, hydrothermal endometrial ablation (HTEA), involves direct exposure of the uterine lining to saline heated to 90 degrees C.
Levonorgestrel-releasing intrauterine device (LNG-IUD: The local administration of the progestin levonorgestrel is delivered via an intrauterine device (IUD). The MIRENA© consists of a T-shaped polyethylene frame with a steroid reservoir around the vertical stem. The reservoir contains 52 mg of levonorgestrel, which is released at a dose of 20 ug per day. The local delivery of this hormone causes the endometrium to become insensitive to ovarian estradiol leading to atrophy of the endometrial glands, inactivation of the endometrial epithelium and suppression of endometrial growth and activity. The effects of this IUD last for approximately 5 years and are reversible upon removal of the IUD.
Radiofrequency endometrial ablation (RFA): This procedure uses a radiofrequency signal generator, a controller and a probe to generate heat in the uterus in an attempt to destroy the endometrial lining.
Uterine artery embolization (UAE): This procedure attempts to block the blood supply to uterine fibroid tumors thus promoting shrinkage through blood deprivation. For UAE to be effective, the arteries and their vascular beds must be completely occluded. The resultant ischemia can result in postembolization pain, but the abundant collateral blood supply in the pelvis protects against ischemic necrosis.
Magnetic resonance imaging (MRI)-guided cryoablation: This procedure is also known as interventional MRI (I-MRI) cryoablation. It uses a specially designed, i-MRI scanner to locate the fibroids and guide their cryosurgical destruction through a transabdominal percutaneous approach. Two major devices are used. The Cryo-Hit(TM) System consists of a structural enclosure, a power control panel, a computer and control assembly, gas supply and distribution systems, cryoprobes, temperature sensors, and a remote control unit. The Signa Profile/i Magnetic Resonance System has an open design and can be utilized during interventional procedures with MRI-compatible devices.
Magnetic resonance imaging (MRI)-guided focused ultrasound (FUA): This procedure combines real-time MRIguidance with high-intensity focused ultrasound for the noninvasive thermal ablation of uterine fibroids. Tumor ablation is performed by focusing a collection of ultrasonic beams to increase sonic beam intensity at a point deep within the tissue to cause thermal coagulation while sparing normal tissues.
Clinical Evidence Endometrial cryoablation (ECA) Searches of the published, peer-reviewed medical literature on endometrial cryoablation identified three single-center, prospective case series on the effectiveness of ECA for menorrhagia. The study populations ranged from 15 to 67 patients.( Rutherford, 1998; Kumar, 2002) Follow-up times ranged from 16 months or less to 22 months. Two additional studies (Duleba, 2003; Corson, 2001) were identified that evaluated outcomes at 1 and 2 years in patients participating in a multicenter, randomized controlled trial to compare the efficacy and safety of ECA with rollerball electroablation (RBEA) for treatment of menorrhagia. These studies were supported by the device manufacturer, CryoGen Inc. The study population consisted of 279 patients who were randomized to ECA or RBEA and followed up to 2 years. One study using ECA to treat fibroids was identified. (Zupi, 2005) Dysfunctional Uterine Bleeding and Uterine Fibroids- Commercial Medical Management Guideline Zupi et al. reported on cryomyolysis with the Her Option Cryoablation Unit for treatment of symptomatic uterine myomas in 20 menstruating women. (Zupi, 2005) At one year follow-up, all patients reported no bleeding and no myoma-related symptoms, comparable with patients who underwent hysterectomy. Mean reduction of myoma volume was 60% one year after surgery. No intraoperative or postoperative complications occurred.
American College of Obstetricians and Gynecologists (ACOG): The ACOG Guidelines for Women's Health (2002) state:
"Women who have failed medical therapy and no longer desire future childbearing are candidates for endometrial ablation, which appears to be an efficient and cost-effective alternative to hysterectomy for anovulatory uterine bleeding.