GammaStar’s Gyro Knife Awarded EU Certification

2008-04-15 11:40 1148

A Kind of Radiotherapy Equipment Comparable to a Proton Center

SHANGHAI, China, April 15 /Xinhua-PRNewswire/ -- GammaStar Medical Group Ltd., an leading international medical company, announces that following over 12 months of development the company’s product, Gyro Knife, has officially been awarded the CE certification for EU medical devices. This is the first time that a product of GammaStar Medical Group Ltd. has been approved for CE certification, which not only shows the improved safety, effectiveness and advancement of the Gyro Knife in the eyes of the authorities of international markets, but also that the product can now be distributed freely within the EU member states, as well as providing precious experience for GammaStar Group. This is a true milestone with a long-term strategic meaning for the Group.

Safety Approved by the EU

In the EU medical appliance market, CE Marking is a mandatory safety conformity mark, which is considered by manufacturers as a passport into the European market, highlighting that a product is in compliance with basic requirements of instruction of the EU New Approach to Technical Harmonization and Standardization. Since the Gyro Knife of GammaStar has passed the CE Marking certification, its safety can now be guaranteed.

Safety of the Gyro Knife is ensured by its unique safety interlock mechanism. There are emergency stop switches installed on the console and in the radiotherapy room, an interlock switch is installed on the shielding door of the radiotherapy room, a collision detecting switch is on the front end of the treatment head of the frame, plus limit switches for three movement directions of the patient support, as well as multiple interlock mechanisms such as voltage detecting interlock, detecting interlock for beam on/off failure, treatment mode interlock and timer failure interlock, all of which can ensure that the equipment is absolutely safe during usage.

The effectiveness in radiation protection of the radiotherapy equipment is an important standard for measuring equipment safety. Radiation source of the Gyro Knife adopts a double-layer sealed structure and in the treatment room there is an environmental detecting instrument, the alarm of which will ring when radiation of the radiation source exceeds acceptable standards. At the same time, the operator is provided with a personal detection device of radiation levels and will test the equipment regularly to ensure safety and reliability of equipment and components.

A Kind of Radiotherapy Equipment Comparable to a Proton Center

The most important index of radiotherapy equipment is the radiotherapy gain ratio, which is not only the most important index for measuring the advancement degree of radiotherapy equipment and represents the development direction of radiotherapy, but also shows the technical advantages of the Gyro Knife. The superior dose distribution curve formed by three-rotary-focusing surpasses the “Prague Peak” of the proton radiotherapy system, and reaches a new development level of SRS. However, investment on the Gyro Knife equipment is only 1/50 of that on the proton radiotherapy system; therefore, we believe this is a kind of advanced radiotherapy equipment that can be popularized.

Meanwhile, the automation degree of the Gyro Knife is far superior to normal radiotherapy equipment. The pellet-filled conformal & intensity-modulated 3-D target technology can treat any part and focus of any size; additionally, a 3-D portrait can be irradiated by randomly combining the radiation fields of different sizes with different irradiation times of each radiation field (3-D scanning conformal & intensity-modulated technology).

Furthermore, focal skin dose ratio of the Gyro Knife is as high as 550:1, which means that after the tissues at focus are killed for once with a dose that is high enough, the dose affecting healthy tissues is negligible, which is the dream of several generations in the global radiotherapy field. It also means that after the series products of Gyro Knife is launched, effectiveness of the radiotherapy will increase greatly, the radiotherapy doctors in the field of tumor treatment will be promoted to a higher status, patients’ pain will be alleviated, most solid tumors won’t need to be treated by operation and thereby the treatment costs will be reduced to a great extent.

Developing towards the International Market

Currently, cancer incidence has increased by an annual rate of 11%; in 2007, there were 12.3 million new tumor cases around the globe and patients dying of cancer took up 1/4 of those dying of diseases. According to research, it has been proven by clinical applications of many countries in the world for years that 80% of cancer patients is applicable to radiotherapy, which not only brings new hope for patients, but also provides a wide market space for promotion and popularization of the Gyro Knife.

It is revealed by Cui Weidong, vice president of the Overseas Business Department of GammaStar Medical Group Ltd., that since the second half of last year, GammaStar has launched its entry plan to the international market, “At present, strategy of the group is laying emphasis on academic cooperation with developed countries and realizing brand penetration through academic recognition, while focusing on product sale in developing countries and rapidly occupying the market during the process of obtaining market recognition.” It is worthy of being mentioned that GammaStar has accomplished academic cooperation with several universities and hospitals in the U.S., and a Hungarian professor once used the Gyro Knife as his object of study and published an essay in an authoritative medical magazine of Hungary, in which technical superiority of the Gyro Knife is highly praised. Till now, GammaStar Group has signed cooperation contracts with medical units of over ten countries and plans to increase 30 international co-operators this year.

At present, GammaStar has established more than 60 chain centers of tumor treatment in China and other countries in the world and plans to increase the number of treatment chain centers to several hundred within 5 years, covering all parts of the world. Simultaneously, its own production bases have been or are being established in China, Singapore and the U.S., etc. It is foreseeable that GammaStar’s development thought of “targeting” equipment in tumor centers, “standardized” operating management and “individualized” treatment schemes conforms to the future development trend of tumor treatments and GammaStar Medical Group Ltd. is developing into a global provider of complete tumor treatment solutions.

Source: Shanghai Gammastar Medical Group
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