MicroVention said that the 500-patient, independently-run, prospective, randomized controlled trial, titled HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS), compared the results from the HydroCoil system to results from bare platinum coils.
The multicenter, multinational trial was the comparitive adjudicated study completed since the International Subarachnoid Aneurysm Trial (ISAT) was presented in 2002, and showed an overall improvement in coiling aneurysms, with a substantially lower 1 year 3% retreatment rate in HELPS as compared to an 11.3% retreatment rate at 1 year with ISAT.
MicroVention said that for patients enrolled in HELPS, the HydroCoil technology, based on a microporous expandable hydrogel, proved to be a more durable solution for endovascular occlusion of aneurysms than bare platinum. HydroCoil is a non-bioactive coil that combines the features of greater aneurysm volume filling with biologically inert scaffolding for natural tissue proliferation.
The key results of the trial showed that HydroCoil had more stable angiographic results with a significant decrease in major remnant/recurrence rates. The primary endpoint of reduction of major aneurysm remnant and recurrence, while neutral, showed a strong trend favoring HydroCoil. There was a very low overall retreatment rate of 3.5% (2.9% HydroCoil vs. 3.6% Bare Platinum).
The effect of HydroCoil on major recurrence was superior in ruptured aneurysms and where increased filling by HydroCoil was achieved. There was a reduction of 20% in HydroCoil length used as compared to bare platinum. Because of HydroCoil’s ability to expand into the aneurysm, there was higher packing density of 68.3% for HydroCoil and 24.9% for bare platinum.
Richard Cappetta, president and chief executive officer of MicroVention-Terumo, said: “These are outstanding results on the safety and effectiveness of HydroCoil, and confirm our belief that HydroCoil is the optimal device for treating a broad spectrum of cerebral aneurysms as compared to bare platinum coils.
“It’s also important to note that these positive results were attained on patients with more large and complex aneurysms. HELPS reinforces many previous multi-center and single-center trials, underscoring HydroCoil’s consistency in reducing aneurysm recurrence and retreatment.”
