Boston Scientific Corporation has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Guglielmi Detachable Coils (GDC) to treat all brain aneurysms. Previously, GDC Coils were indicated only for treatment of high-risk or inoperable ruptured and unruptured brain aneurysms. The expanded indication is significant because it will help bring a less-invasive alternative to surgery to as many as 17 million people who have a brain aneurysm.

Brain aneurysms are usually treated after rupture but are sometimes treated beforehand to prevent rupture from occurring. When a brain aneurysm ruptures, blood flows into the space surrounding the brain (the subarachnoid space), resulting in a subarachnoid hemorrhage, the deadliest form of stroke. Each year approximately 30,000 people in the United States suffer a ruptured brain aneurysm, and more than 50 percent of these patients will die within the first 30 days after rupture.

Historically, most brain aneurysm patients in the United States have been treated by neurosurgical clipping, which involves performing a craniotomy (temporarily removing a section of the skull during surgery) and placing a surgical clip at the neck of the aneurysm. However, increasingly more patients are receiving less-invasive endovascular coil treatment. It is estimated that as many as 50 percent of patients treated for brain aneurysms this year will receive endovascular treatment. Endovascular coil treatment involves insertion of a catheter into the femoral artery in the patient's leg and navigating it through the vascular system under X-ray guidance into the head and into the aneurysm. Tiny platinum coils are then threaded through the catheter and deployed into the aneurysm, obstructing blood flow into the aneurysm and preventing further damage.

Results from the International Subarachnoid Aneurysm Trial (ISAT) published in the peer-reviewed medical journal The Lancet demonstrated that in ruptured brain aneurysm patients equally suited for both surgical and less-invasive treatment options, endovascular coil treatment is significantly more likely to leave patients alive and free of disability at one-year follow-up than is surgical clipping. Other studies have demonstrated that unruptured brain aneurysm patients treated surgically have three times the risk of adverse outcomes and hospital stays twice as long as patients treated with coiling. The FDA cleared the expanded indication for GDC Coils based on the ISAT results. GDC Coils were the only coils used in the published ISAT one-year results.

Since their introduction in 1991, GDC Coils have been selected by physicians around the world to treat more than 125,000 patients. Building on GDC coil technology, Boston Scientific recently introduced the next-generation Matrix Detachable Coils that feature a proprietary bioabsorbable, copolymer coating. Compared to bare platinum coils in pre-clinical animal studies, Matrix Detachable Coils increased the amount of mature, intra-aneurysmal connective tissue, increased aneurysm neck tissue thickness, and reduced aneurysm size. Matrix Coils have already been used to treat more than 1,000 patients worldwide.