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

• 98% of patients reported a return to normal menstrual bleeding, hypomenorrhea or amenorrhea¹
• 82% of patients were satisfied with their treatment²
• 92% of patients avoided hysterectomy⁷
• 75.6% of patients experienced a reduction in bleeding and required no additional therapy; 8% underwent hysterectomy. (Median of 19 months ranging from 6 to 60 months)⁷

Low Subsequent Hysterectomy Rate vs. RF

A retrospective review comparing outcomes of patients treated with Thermablate (N=168) and Novasure (N=123) over 5 years showed, “More women opted for hysterectomy in the Novasure group (20.3%) as compared to 8.3% in the Thermablate EA.”
See Fig 1⁷.

Fig 1⁷

 

These data are further supported by the findings in Fig 2. which show that of 3681 endometrial ablations performed from 1999-2004, a larger percentage of patients treated with radio frequency ablation underwent eventual hysterectomy when compared to thermal balloon patients.⁸

Fig 2⁸

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” ⁹

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)

1. D’Afiero A et al. Efficacy of a Second Generation Thermal Balloon Device in the Treatment of Anemia Induced by Meno/Metrorrhagia. Int Jour of Gyne & Obstet 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 Experimental Obstet & Gynecol 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 Journal 2016; 4(5):00127.
4. Leyland N. Office Based Global Endometrial Ablation: Feasibility and Outcome for 3 Modalities. Journal of Obstet and Gynecol Canada, 2004; 26:S22.
5. Hall M, Woodward Z. Outpatient Endometrial Ablation: Patient Reported Efficacy and Acceptability. Royal College of Obstet and Gynecol World Congress 2016; Poster Presentation.
6. Prasad P, Powell M. Prospective Observational Study of Thermablate Endometrial Ablation System as an Outpatient Procedure. J Min Invas Gynecol 2008; 15:476-479
7. Chen BF M et al. An Observational Study on the Long Term Follow-up Following Thermablate and Novasure Endometrial Ablations. Obstet Gynecol Int J7:00252 2017.DOI:10.15406/ogij.2017.07.00252
8. Longinotti MK, Jacobson GF, Hung Y, Learman LA. Probability of Hysterectomy After Endometrial Ablation. Obstet Gynecol 2008; 112:1214-1220.
9. 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 of Gynecologic Surgery, 2011;27:S4. https://doi.org/10.1089/gyn.2010.0043