Healthcare Professionals

Proper patient selection is very important to consider. Not all women can undergo a Thermablate treatment. Patients should always be evaluated thoroughly prior to treatment to rule out any underlying causes of their excessive uterine bleeding.

Potential Thermablate patients must meet certain criteria to be eligible for treatment:

• Excessive uterine bleeding with no underlying causes
• Completed childbearing
• Pre-menopausal normal uterine cavity with sounding between 8cm and 12cm, inclusive
• Normal endometrial biopsy and pap smear in accordance with Clinical Practice Guidelines

Contraindications

It is important to rule out contraindications prior to treating a patient with the Thermablate system. Most importantly, patients should understand that becoming pregnant after a Thermablate procedure is possible but it may be unsafe for both the mother and the fetus. Proper birth control counselling should be provided to patient’s pre and post procedure.

Repeat endometrial ablations should not be offered or attempted with Thermablate EAS as the uterine cavity is likely distorted.

Click here for full list of contraindications

 

1. User slowly inserts catheter until balloon tip touches the fundus of the uterine cavity
2. Depth markings on catheter must match previously obtained sounding measurements
3. Treatment cycle is activated with a simple finger trigger switch
4. Thermablate system automatically inflates and deflates the balloon to ensure consistent delivery of
   energy and contact with the endometrium

Proven long-term results demonstrate high efficacy and patient satisfaction, as well as low re-intervention in the form of hysterectomy

 

At Two Years

• Up to 98% of patients reported return to normal menstrual bleeding, hypomenorrhea or amenorrhea¹
• 82% of women were satisfied with their treatment²

At a Median of Five Years

• 93.6% of women avoided hysterectomy³
• 80% of patients experienced reduction in menstrual bleeding and required no additional therapy. 6.4% underwent hysterectomy³

Success Measured as Improved Quality of Life

Thermal balloon ablation offers many benefits over competitive Global Endometrial Ablation systems and is the ideal treatment option for avoiding long-term complications such as De Novo (newly onset) Pelvic Pain.

“De Novo pelvic pain occurred overall in 20% of radiofrequency patients and 7% of Thermal Balloon patients” ⁴

A study comparing the incidence of De Novo Pelvic Pain within 2 years of either Radiofrequency (RF) or Balloon Ablation found that:

• More focus is being placed on improved quality of life rather than solely menstrual patterns post ablation
• The possibility of De Novo Pelvic Pain post-ablation should be reviewed with the patient pre-procedure
• The incidence as well as its associated severity varies by mode of therapy (RF>TB)

 

Five Year Follow-Up Data

Thermal balloon ablation is the ideal treatment option for avoiding hysterectomy and De Novo Pelvic Pain post-ablation:

A retrospective review comparing outcomes of patients treated with Thermablate (N=175) and Novasure (N=133) over 5 years showed “An eventual hysterectomy was carried out in 18.7% of the Novasure women vs 8% of the Thermablate group.” ⁵

These data are further supported by the findings in Figure 2, which shows that of 3861 endometrial ablations performed from 1999-2004, a larger percentage of patients treated with Radiofrequency (NovaSure) ablation underwent eventual hysterectomy when compared to Thermal Balloon patients.⁶

1. D’Afiero A et al. Efficacy of a Second Generation Thermal Balloon Device in the Treatment of Anemia Induced by Menorrhagia. International Journal of Gynecology & Obstetrics 2012; S261-S530.
2.Karamanidis D et al. Two Year Results of a New Two Minute Hot Liquid Balloon Endometrial Ablation System(Thermablate): A Pilot Study. Clinical and Experimental
Obstetrics & Gynecology 2009; 36(4): 256-258.
3. Qaiser A, Chen BF, Powell MC. A Long Term Follow up of Results of Women undergoing an Office Based Thermablate Endometrial Ablation for the Treatment of Menorrhagia.
Obstet Gynecol Int J 2016, 4(5): 00127.
4. Chapa H, Antonetti A, Sandate J, Bakker K, Silver L. Incidence of de Novo Pelvic Pain After Radiofrequency or Thermal Balloon Global Endometrial Ablation Therapy.
J Gynecol Surg 2011; 27(4): 203-207
5. Powell M et al. Subsequent Intervention Rates Following Thermablate and Novasure Endometrial Ablations. J Min Invas Gynecol 2014; 21:S136-S1
6. Longinotti MK, Jacobson GF, Hung Y, Learman LA. Probability of Hysterectomy after Endometrial Ablation. Obstetrics and Gynecology 2008; 112:1214-1220.90