Coil Embolization Treatment 'Safe and Effective,' According to British Health Advisory Committee
(February 16, 2005) -- Boston Scientific Corporation (NYSE: BSX) today welcomed an announcement by the Interventional Procedures Advisory Committee (IPAC) of the United Kingdom's National Institute for Clinical Excellence (NICE), confirming the safety and efficacy of coil embolization for the treatment of ruptured and unruptured brain aneurysms.

A brain aneurysm, also called an intracranial or cerebral aneurysm, is an abnormal weakening of an artery in the brain that causes a ballooning of the vessel wall. Ruptured aneurysms cause strokes by leaking oxygenated blood into the areas around the brain.

Treatment of brain aneurysms using coil embolization, or endovascular coiling, involves insertion of a catheter into the femoral artery in the patient's leg and navigating it through the vascular system, into the brain and into the aneurysm. Tiny platinum coils are threaded through the catheter and deployed into the aneurysm, blocking blood flow into the aneurysm and preventing rupture.

In contrast to surgical clipping, the traditional surgical treatment for aneurysms, endovascular coiling does not require open surgery. Instead, physicians use fluoroscopic imaging to visualize the patient's vascular system and treat the disease from inside the blood vessel. Analyses have found that endovascular coiling is associated with lower risk of negative outcomes, shorter hospital stays and shorter recovery times, compared with surgery.

A study published by the journal Lancet in 2002 revealed that there was a 23 percent relative risk reduction, or 7 percent absolute risk reduction, in death and disability at the end of one year in patients receiving coiling compared to clipping, illustrating the benefits of coil embolization over open brain surgery. Clinicians also welcomed the IPAC recommendations on endovascular coiling. "Coil embolization offers patients with a ruptured aneurysm a safer and less-invasive treatment with an improved chance of recovery for a condition that could easily be fatal," said Anil Gholkar, M.D., consultant neuroradiologist, of the Regional Neurosciences Centre in Newcastle-upon-Tyne, England. "The coiling procedure is highly effective in stopping blood flow through an aneurysm, preventing early rupture. Brain hemorrhage is something that affects thousands of people every year. Fortunately, we have been able to develop techniques and treatments which significantly reduce risk to patients. The coiling procedure is a highly useful example of how less-invasive technologies are working to the benefit of patients in the U.K. Neruoradiologists and neurosurgeons are working together to provide the best available treatment."

NICE was established in 1999 as a Special Health Authority and is part of the National Health Service. It provides guidance to patients, health professionals and the public on current best practices in medicine. Its guidance covers both individual health technologies (including medicines, medical devices, medical procedures and diagnostic techniques) and the clinical management of specific medical conditions. Boston Scientific participated in the IPAC consultation process and provided data as part of the appraisal process.

Boston Scientific manufactures the GDC™ and Matrix™ Detachable Coil systems for the treatment of brain aneurysms.

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