InSightec receives Chinese clearance for ExAblate system to treat uterine fibroids

29 July 2013 (Last Updated July 29th, 2013 18:30)

Israel-based ultrasound technology provider InSightec has received approval from the Chinese Food and Drug Administration (CFDA) for its non-invasive ExAblate system, which is used in the treatment of uterine fibroids.

Israel-based ultrasound technology provider InSightec has received approval from the Chinese Food and Drug Administration (CFDA) for its non-invasive ExAblate system, which is used in the treatment of uterine fibroids.

Using ultrasound energy, the device destroys the fibroids, while its magnetic resonance imaging (MRI) images help doctors in planning and administering an appropriate therapy and monitoring the treatment outcome.

As well as being incisionless, the other advantages associated with the ExAblate device are that it does not require patients to be hospitalised, offers a high safety profile to patients due to low risk of infection and complications and also helps them in recovering faster.

Uterine fibroids are mostly removed through a surgical method called hysterectomy.

Between 20% and 50% of women of childbearing age suffer from uterine fibroids, benign tumors that grow in the uterus.

According to National Institute of Health (NIH), uterine fibroids are made of muscle cells and other tissues that grow in and around the wall of the uterus, or womb.

"It is a safe and effective way to treat women with symptomatic fibroids and should be offered as a non-invasive treatment option."

InSightec founder and CEO Dr Kobi Vortman said that thousands of women have been treated with the system so far around the world.

"We are extremely proud to have received CFDA approval for ExAblate which is another vote of confidence in ExAblate's high safety profile and excellent outcomes," said Vortman.

The CFDA approval of ExAblate system was based on data of clinical trials conducted at Peking Union Medical College Hospital and China Medical University First Hospital.

Clinical trials lead investigator Jin Zhengyu said that in the clinical study it was found that patients who underwent ExAblate treatment were able to return home within a few hours and to normal life within a day or two.

"It is a safe and effective way to treat women with symptomatic fibroids and should be offered as a non-invasive treatment option," said Zhengyu.

The system, which received the US FDA approval in 2004, is claimed to be the only MR guided ultrasound system to have secured both US FDA and CFDA clearances.

Earlier this month, the company received an extended European CE Mark for its ExAblate 2000 and 2100, as well as the ExAblate 2100 Conformal Bone System.

These systems are meant for the local treatment of cancerous and benign primary and secondary bone tumors, including multiple myeloma, bone metastases and osteoid osteoma, as well as facet joint back pain.