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Boston Scientific Welcomes Results of Brain Aneurysm Clinical Trial
Date:5/26/2009

eeding from a coiled aneurysm in the first five years, fewer coiled patients died at five years, and there have been no observed hemorrhages from a coiled aneurysm in these patients after five years."

"The extraordinary work by Drs. Molyneux and Kerr and the ISAT investigators represents a milestone in the evolution of treatment for cerebral aneurysms," said Mark Paul, President, Boston Scientific Neurovascular. "The data from ISAT over the last six years have informed the worldwide neurovascular community and helped physicians better determine the best treatment options for patients suffering from a ruptured aneurysm."

The primary objective of ISAT was to determine whether endovascular treatment reduced the rates of patient death or dependency at one year compared with surgical treatment. The trial, supported by the U.K.'s Medical Research Council (MRC), began as a pilot study in 1994 and enrolled 2,143 patients at 43 neurosurgical centers who were randomly assigned to coiling or clipping. Patients were primarily treated with the early generation of Boston Scientific's GDC(R) Coils, some as far back as 14 years when technology, angiographic imaging equipment and physician experience differed significantly from today. One-year results reported in 2002 demonstrated a 24 percent relative risk reduction in death or dependency in patients treated with endovascular coiling compared to surgical clipping, which is consistent with five-year results.

"ISAT has required the dedication of doctors, nurses, trial staff, patients and their relatives over many years, and we are extremely grateful to them all," said Dr. Molyneux. "The positive trial results should reassure patients and physicians that treatment with endovascular coiling is safe in the short term while also providing a long-term benefit of lower death risk compared to surgical intervention. The latest data continue to support the general shift toward coili
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SOURCE Boston Scientific Corporation
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