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【medical-news】大脑刺激装置对卒中无效未能获批

Test of Brain Device Is Setback for Maker

Any impact that Tuesday’s plunging stock markets might have had on Northstar Neuroscience was lost in the bad news released before trading began — results from a crucial clinical trial showed that its brain-stimulating device failed to help stroke victims recover the use of their arms and hands.

Northstar, which is based in Seattle, said it would drop efforts to have the therapy approved by regulators. Northstar’s stock, which ended Nasdaq trading on Friday at $8.36, plunged as low as $1.09 before recovering slightly to end the day at $1.37, down 83.6 percent.

The trial results highlighted the hit-or-miss nature of efforts to develop devices that use electrical stimulation or magnetic fields to treat brain and nerve disorders.

Mindful of successes treating conditions as diverse as epilepsy, deafness and chronic pain, device makers have been investing heavily in what James Cavuoto, publisher of Neurotech Reports, forecasts will be a $3.6 billion neurotechnology market this year.

Northstar has focused on the brain’s outer layer, or cortex, as opposed to deep-brain stimulation or stimulation of the spinal cord or major nerves before they enter the brain. The company has studied treatment of major depression and the chronic ringing in the ears called tinnitus by stimulating various regions of the cortex, but it had bet heavily on reaching the market first with stroke therapy after initial research produced promising data.

“To put it mildly, we are extremely surprised and disappointed by these results,” said John S. Bowers Jr., Northstar’s president and chief executive, in a conference call with analysts.

In the trial, stroke victims who had lost control of a hand or arm received either vigorous physical therapy or the physical therapy as well as gentle stimulation from the Northstar Renova, a device the size of a pocket watch that was implanted in the upper chest and connected to the brain by a wire.

Northstar said that analysis of results after four weeks showed that the group getting only physical therapy had done much better than previous research had indicated — so much so that there was no advantage to the stimulator. Preliminary data from patients followed for 24 weeks showed no change in the pattern, Northstar said.

Looking for a silver lining for patients if not investors, Mr. Bowers told analysts that the trial might have demonstrated the value of providing aggressive physical therapy for all stroke victims.

http://www.nytimes.com/2008/01/23/business/23device.html?ref=health
screen.width-333)this.width=screen.width-333" width=359 height=264 title="Click to view full 20061205161902.jpg (359 X 264)" border=0 align=absmiddle> 本人已认领该文编译,48小时后若未提交译文,请其他战友自由认领。 粗译如下:

Test of Brain Device Is Setback for Maker
试验结果让脑部仪器生产商失望

Any impact that Tuesday’s plunging stock markets might have had on Northstar Neuroscience was lost in the bad news released before trading began — results from a crucial clinical trial showed that its brain-stimulating device failed to help stroke victims recover the use of their arms and hands.
周2证券市场开盘前得到消息,一项重要的临床试验显示“北星神经科学”公司的脑刺激装置不能改善中风患者的上肢功能。这对当日的北星股价造成了重大影响。

Northstar, which is based in Seattle, said it would drop efforts to have the therapy approved by regulators. Northstar’s stock, which ended Nasdaq trading on Friday at $8.36, plunged as low as $1.09 before recovering slightly to end the day at $1.37, down 83.6 percent.
坐落于西雅图的北星公司说,他们将努力使该治疗方法得到核对者的认同。纳斯达克证券市场上,北星股份周五交易价为$8.36,一度跌至$1.09,后稍有回升,以$1.37收盘,跌了约83.6个百分点。

The trial results highlighted the hit-or-miss nature of efforts to develop devices that use electrical stimulation or magnetic fields to treat brain and nerve disorders.
试验结果强调,该公司没有用心开发这种通过电刺激或磁场来治疗脑部或神经紊乱的设备。

Mindful of successes treating conditions as diverse as epilepsy, deafness and chronic pain, device makers have been investing heavily in what James Cavuoto, publisher of Neurotech Reports, forecasts will be a $3.6 billion neurotechnology market this year.
鉴于其对癫痫、失聪、慢性疼痛的成功治疗,仪器厂商们对该设备的开发投入重金。“神经技术报告”出版商James Cavuoto先生预期今年神经技术市场的份额将达36亿。

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作者:admin@医学,生命科学    2011-04-09 17:14
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