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Israel's InSightec Company announced that its focused ultrasound uterine fibroids treatment device ExAblate has obtained approval from the Chinese CFDA and will enter the Chinese market for promotion and sales. This is the first imported focused ultrasound tumor therapy instrument approved by China.
Focused ultrasound tumor therapy equipment uses high-intensity ultrasound to generate heat in the human body, causing specific tumor cells to coagulate necrosis, which has obvious effects in palliative treatment of tumors. Because of its non-invasive, low-risk and fast recovery characteristics, it has significant clinical application significance for cancer patients who cannot undergo chemotherapy or surgery. Focused ultrasound technology in China started early and is one of the few "dark horse" industries in the field of large-scale medical equipment that has reached the international advanced level. At present, the main domestic enterprises include Chongqing Haifu Medical, Shanghai Aishen Technology, Shanghai Jiaotong University Xindi Industry, etc.
Among them, Chongqing Haifu is a representative enterprise focusing on ultrasound technology. According to the information provided by Haifu to the Minenet device group, the company's products have been exported to more than 20 hospitals in 14 countries and regions such as the United Kingdom, Italy, and Russia; as of August 2012, there were more than 1,560 medical institutions at home and abroad With the company's series of products, more than one million cases have been treated. The domestic focused ultrasound field is developing well.
InSightec's ExAblate was approved by the FDA in 2004 for the treatment of uterine fibroids. In recent years, it has expanded to indications such as bone pain, prostate cancer and liver cancer. After Beijing Union Medical College Hospital and China Medical University First Affiliated Hospital launched Chinese clinical trials, it was approved by CFDA this time. The indication for CFDA approval for ExAblate is uterine fibroids. According to InSightec, about 20% to 50% of women of childbearing age have uterine fibroids.
InSightec is controlled by GE Group, and its ExAblate guidance system also uses GE Group's 3.0T MRI MRI. At present, domestic focused ultrasound uses ultrasound guidance, and MRI guidance has certain advantages in positioning tumors and monitoring target temperature. Will foreign-invested focused ultrasound products enter China for the first time, will it impact the domestic rising medical equipment industry?
The answer is not to be afraid. Minet interviewed the relevant person in charge of the Haifu Medical Marketing Department. He said that MRI guidance is a big deal for small cases. "Ultrasound can't penetrate bones. Even if MRI can see the tumor behind the bones, the focused ultrasound used for ablation can't reach the lesion." "The outstanding feature of MRI is that it can measure the temperature in real time to determine whether the target reaches the ablation temperature Experienced doctors can also use ultrasound guidance. "
On the other hand, for ordinary tumors, general ultrasound guidance is sufficient, and the use of large-scale MRI will increase the cost of treatment for patients. The person in charge said: "Taking the treatment of uterine fibroids as an example, the cost of treatment using MRI will reach 20,000, and ultrasound guidance only costs thousands of yuan." He emphasized that Haifu's products have been safely applied to uterine fibroids over 1 Ten thousand cases.
The person in charge also said that the company's MRI-guided focused ultrasound has also been in clinical trials and will expand more therapeutic areas. The company has cooperated with Siemens, an international advanced company, and will continue to lead in MRI guidance technology in the future.
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