Final Published Trial Data in The Lancet Supports Safety and Effectiveness of MicroVention-Terumo's HydroCoilÃ‚® Embolic System for Treatment of Cerebral Aneurysms
TUSTIN, Calif., May 31, 2011 /PRNewswire/ -- MicroVention-Terumo, Inc., a leader in developing, manufacturing and marketing interventional neurovascular devices, announced today the final 18-month follow-up data in a landmark international study. The HydroCoil® Endovascular Aneurysm Occlusion and Packing Study (HELPS) published in The Lancet, showed that the HydroCoil Embolic System for treating cerebral aneurysms reduced recurrence and retreatment rates and provided improved outcomes in study patients when compared to bare platinum coils. A cerebral aneurysm is an abnormal, weakened area on the wall of a blood vessel in the brain that causes it to bulge or balloon out. If a cerebral aneurysm ruptures, it can cause a hemorrhagic stroke, a serious medical condition, which can lead to brain damage and death.
HELPS was a prospective, randomized controlled trial that compared the results from the HydroCoil system to results from bare platinum coils. The 500-patient, independently-run, multicenter, multinational 18-month trial was the first comparative adjudicated study completed since the International Subarachnoid Aneurysm Trial (ISAT) was presented in 2002. HELPS results were published in the prestigious journal, The Lancet, by the lead author and primary investigator, Philip White, M.D., of Western General Hospital in Edinburgh, Scotland.
"Our study shows that the non-invasive techniques for treating brain aneurysms are getting better. Hydrogel coated coils offer an improved treatment for ruptured aneurysms and coiling has a faster recovery than having to have brain surgery and come with less risk as well, which is great news for the thousands of people affected by this condition each year," said Dr. White.
HELPS Trial results showed that the HydroCoil system, based on a microporous expandable hydrogel, proved to be a more stable solution for endovascular occlusion of aneurysms than bare platinum. The Hydr