On 18th January 2013, COFEPRIS, a division within the Mexican Ministry of Health (Secretaria de Salud) responsible for medical device oversight in the country, issued registration for Halt Medical's Acessa system to for the treatment of symptomatic uterine fibroids.
The Acessa system is used in a minimally-invasive out-patient surgery procedure where a hand-piece is used to deliver radiofrequency energy to the fibroid, after which the fibroid is re-absorbed by the surrounding tissue. The system treats just the fibroids, preserving the normal function of the uterus. Patients typically go home the same day with little pain and experience rapid recovery and return to normal activities. According to 94 per cent of the patients in Halt's IDE trial, their symptoms were resolved following treatment with the Acessa procedure.
The results of both US and international trials have led to the clearance of the Acessa system by the FDA, reported by Espicom in November 2012, for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The system also has regulatory approval to treat symptomatic uterine fibroids in the EU, Canada and Mexico.