The Lancet Publishes 18-Month HELPS Data for MicroVention-Terumo's HydroCoil

May 31, 2011—MicroVention-Terumo, Inc. (Tustin, CA) announced that the final 18-month follow-up data in the HELPS (HydroCoil Endovascular Aneurysm Occlusion and Packing Study) international study were published by Philip M. White, MD, et al in The Lancet (2011:377:1655–1662). The findings showed that the company's 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.

As reported by Endovascular Today, Dr. White originally presented the results at the 7th annual meeting of the Society of Neurointerventional Surgery in Carlsbad, California on August 3, 2010.

HELPS was a prospective, randomized controlled trial that compared the results from the HydroCoil system to results from bare-platinum coils. The multicenter, multinational trial was independently run and enrolled 500 patients over 18 months. The HydroCoil implant is a nonbioactive coil that combines platinum with an expanding hydrogel polymer, which provides the greater aneurysm volume filling with biologically inert material for natural tissue proliferation.

According to the company, the HELPS trial findings showed angiographic results from an independent core lab that indicated there was a statistically significant decrease (8.6%) in major aneurysm recurrence with the HydroCoil system arm as compared to the bare-platinum control arm. Aneurysms in the trial ranged in size from 2 mm to 25 mm, and 84% of all aneurysms were medium and large in size.

MicroVention-Terumo stated that in HELPS, the HydroCoil proved to be a more stable solution for endovascular occlusion of aneurysms than bare platinum. Key trial results for the HydroCoil compared to the bare-platinum device demonstrated statistically significant, more stable angiographic results with a significant decrease in major remnant/recurrence rates. The primary composite endpoint was neutral but showed a strong trend favoring the HydroCoil embolic system. Also, the HydroCoil compared favorably to the bare-platinum device with a very low retreatment rate (3% vs 4%), superior outcomes in treatment of ruptured aneurysms (68% vs 50%), and less thromboembolic complications (5.6% vs 10%). The HydroCoil resulted in a higher packing density with less coil length (reduction of 20% as compared to bare platinum) due to its expansion properties (63.9% vs 23.2%). Finally, the investigators reported superior outcomes when the targeted amounts of HydroCoil implants were achieved in aneurysms (> 50% HydroCoil implant length per protocol).

Procedural safety and efficacy results for HELPS that were previously published by Dr. White et al in the American Journal of Neuroradiology showed that the HydroCoil system can be safely used in a wide spectrum of aneurysms with a risk profile equivalent to that of bare-platinum coils (2008;29:217–223).

“Our study shows that the noninvasive techniques for treating brain aneurysms are getting better,” commented Dr. White. “Hydrogel-coated coils offer an improved treatment for ruptured aneurysms, and coiling has a faster recovery than having to have brain surgery, and comes with less risk as well, which is great news for the thousands of people affected by this condition each year.”