Indications For Use, Contraindications, and Warnings
Acessa Health | April 1, 2020
Indications for use:
The Acessa ProVu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.3
- Patients who are not candidates for laparoscopic surgery (e.g., patients with known or suspected intra-abdominal adhesions that would interfere with safe use of the Handpiece).
- Uterus adherent to pelvic tissue or viscera.
- Non-uterine pelvic mass.
- Acessa ProVu System’s guidance system is not intended for diagnostic use.
- The Acessa ProVu System’s guidance system may not be used to guide the tip of the Handpiece once the tip has penetrated the uterine serosa. Ultrasound visualization must be used during fibroid penetration and treatment.3
Warnings regarding patient selection:
- Insufficient data exist on which to evaluate the safety and effectiveness of Acessa procedure in women who plan future pregnancy. Therefore, the Acessa procedure is not recommended for women who are planning future pregnancy.
- The safety and effectiveness of the Acessa procedure has not been evaluated in women with uterine size >14 weeks.
- Uterine tissue may contain unsuspected cancer, particularly in patients who are peri- or post-menopausal. Insufficient data exist on which to evaluate the safety and effectiveness of the Acessa procedure for treatment of cancerous uterine tissue. Thoroughly discuss the benefits and risks of all treatments with patients.
- If the patient has a pacemaker, consult the patient’s cardiologist prior to this procedure. Using the Acessa ProVu System in the presence of an internal or external pacemaker may require special considerations.
- Treatment with the Acessa ProVu System is not recommended for nursing mothers or pregnant women.
- Electrosurgery is not recommended for patients with metal implants near the ablation site or along the RF return path to Pads (e.g., hip and back implants are in the RF path, knee implants are not in the RF path).
- Treatment of children is limited due to the physical size and placement of Pads with respect to RF ablation site.3
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