STARmed Fibroid RFA

Non-surgical. Incision-free. Uterine preserving.

The incision-free, uterine-sparing technique that women seek

Radiofrequency ablation (RFA) for fibroids has been around since the 1990s, which uses heat to achieve contact coagulative necrosis of the fibroids. At STARmed, we pioneered fibroid ablation with transvaginal ultrasound guidance, allowing our devices to seamlessly integrate with almost all available ultrasound systems. This eliminates the need for incisions, making it a simpler procedure for physicians and a truly minimally invasive solution that relieves patient symptoms while preserving their uterus.

11 million1

women in the U.S. are currently diagnosed with fibroids.

320,000+2

hysterectomies are performed for benign indications annually in the U.S

79%1

of women want to avoid invasive surgeries and long recovery times.

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Transvaginal imaging, transcervical ablation

The STARmed Fibroid RFA procedure utilizes real-time transvaginal ultrasound guidance to accurately locate fibroids. This facilitates the insertion of the star RF Electrode through the cervical canal into the targeted fibroid, allowing for precise ablation initiation and effective fibroid treatment in a less invasive manner.

Flexible system

The star RF Electrode is designed to work seamlessly with nearly all ultrasound systems and is fully compatible with their transvaginal ultrasound probes. The electrode is inserted through the ultrasound probe guide during the procedure, ensuring continuous in-plane visualization for optimal accuracy.

Star RF Electrode

The star RF Electrode comes with 2 shaft lengths, 25 cm, and 35 cm, with 3 different active tip lengths, 1.0 cm, 2.0 cm, and 3.0 cm, to suit different clinical needs.

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STAR Technique

STARmed’s cool-tip technology is specifically designed to promote the  STAR Stepping Target Ablation in Real-time technique to ensure safe and efficient ablation for uterine fibroids. Partnering with the internal cooling system and the real-time impedance feedback via the VIVA combo RF System, STARmed Fibroid RFA maximizes ablation zones without damaging the surrounding structures.

Clinical-based evidence

According to a few recent prospective observational studies, the mean volume reduction rate at 12 months was up to 73.5%, with a significant reduction of symptoms demonstrated by percentage variation of UFS-QOL Symptom Severity Score of -74.3% at 1 month after the procedure.3,4

Before
STARmed Fibroid RFA

6 months after
STARmed Fibroid RFA

PRODUCT INDICATIONS

The VIVA combo RF System is FDA-cleared and intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

  1. Marsh EE, Al-Hendy A, Kappus D, Galitsky A, Stewart EA, Kerolous M. Burden, Prevalence, and Treatment of Uterine Fibroids: A Survey of U.S. Women. JWomens Health (Larchmt). 2018;27(11):1359-1367. doi:10.1089/jwh.2018.7076
  2. Plotting the Downward Trend in Traditional Hysterectomy (2018)
  3. Fasciani A, Turtulici G, Siri G, Ferrero S, Sirito R. A Prospective Intervention Trial on Tailored Radiofrequency Ablation of Uterine Myomas. Medicina (Kaunas). 2020;56(3):122. Published 2020 Mar 12. doi:10.3390/medicina56030122
  4. Rey VE, Labrador R, Falcon M, Garcia-Benitez JL. Transvaginal Radiofrequency Ablation of Myomas: Technique, Outcomes, and Complications. J Laparoendosc Adv Surg Tech A. 2019;29(1):24-28. doi:10.1089/lap.2018.0293