BBI Japanese Editor
Japan Medical Dynamic Marketing (Japan MDM; Tokyo) has completed development of a high-frequency neurosurgical device, pursuing an idea originally developed at the University of Nebraska (Lincoln, Nebraska) by Dr. A. Patil. Approved by the Ministry of Health and Welfare (MHW) in May 1999, the company began marketing the device in Japan and Southeast Asian countries in October 1999. The company is expecting FDA and CE Mark approval around the end of this year.
While electrosurgical devices have been in use for some time, none has been used for neurological surgeries due to electric current flowing through the body arising from the use of a grounding pad and causing thermal damage to surrounding tissue. The new device, named the EMF System PAL-1, is characterized by using extremely low electric current which is almost harmless to surrounding tissues in the brain and capable of pinpointing the lesion, controlling bleeding and providing tactile feedback, giving the operator an increased confidence in highly sophisticated surgeries of cutting and coagulation (hemostasis) as well as removal of a lesion. All of these features contribute to shortening operating time to one-third of that when using conventional devices. Lasers, a contending technology, are prone to the scattering of light reflected by metals, and lack tactile feedback, in addition to being expensive. The EMF System has been successfully used in about 160 procedures, mainly for removing deep-seated brain tumors. When used in deep tumor applications, conventional microinstruments are used by many surgeons until access to the tumor itself is achieved before switching to the EMF system.
The device consists of an RF generator, two types of handpieces, an extension cable and a series of electrode tips. A compactly designed RF generator, weighing 17.5 kg, generates a maximum output of 49 watts at a frequency of 13.56 MHz. While a limiter featured in the generator cuts off the power in three minutes for safety considerations, the RF generator withstands unlimited extended use. Extremely light handpieces include a straight pencil type and a bayonet pencil type, the latter with a cranked and shorter shaft designed to provide an unobstructed view of the lesion for the operator performing the microsurgery. Four types of monopolar electrode tips – a ball type, a ring type, a needle type and a blade type – are available, which can be selected to the surgeon's preference. Each tip is designed to be readily exchanged during the operation. The ball-type tip is for vaporization, the needle and the blade types are for cutting, and the ring type for resection of large tissue masses. While monopolar electrodes typically require a grounding pad, monopolar electrodes employed in the EMF System do not require one, resulting in minimal thermal effect arising from the flow of the electric current; a bipolar version also is contemplated for future development. Tips, designed as disposables, can be reused for approximately 10 procedures and are sterilizable in regular hospital autoclaves; handpieces are gas-sterilized. The device is priced at about $35,000. Japan MDM plans to develop versions of the EMF System for other surgical applications in the future.
Japan MDM has a U.S. subsidiary company in Utah, Ortho Development Corp. (ODC), which has been manufacturing orthopedic devices mainly used in joint replacement and spinal surgery. When ODC obtains its FDA and CE approvals, it will market the EMF System worldwide except in Japan, southeast Asia and India. ODC is in the process of negotiating with 13 firms for distribution in the U.S. Japan MDM said at least 20 distributors will be necessary in order to cover the U.S. market. In Asia, five distributors have been appointed in Taiwan, China, Korea, Singapore and India. So far, Japan MDM installed 13 units in these markets, including Japan. Since most hospitals in Japan close their fiscal year by the end of March, Yasuo Watanabe, president of Japan MDM, expects purchases of the EMF System to sharply increase when the new fiscal year begins. Viewing Asian countries as the fastest-growing market after the U.S. and Europe, Watanabe appointed Wei Zhao, a Chinese citizen, as R&D director and Ken Yamada, a Canadian citizen and an expert in international markets, as the international division director. Both are thoroughly versed in Asian markets.
Founded in 1973, Japan MDM has been marketing in Japan orthopedic products of ACE (now DePuy Ace). Nearly 75% of Japan MDM's sales come from trauma-related products. It also will soon begin marketing spine-related products. Application for marketing approval on knee joint prosthesis also is being filed with the MHW. Products in the development pipeline include kinetic products that maintain a patient's functions to expedite discharge from the hospital and the JanaCare II table base lateral rotational bed for preventing secondary complications associated with ICU patients. Another product being developed is a device for controlling brain temperature, used in brain hypothermia treatment where the brain temperature is reduced to 32 degrees C and is controlled in order to prevent damage and subsequent vegetative states.
A session for reporting on experiences accrued by members of a new Japan MDM international advisory board is set for the April meeting of the American Association of Neurological Surgeons in San Francisco, California. Japan MDM went public last year.