Terumo subsidiary MicroVention, Inc., has announced that enrollment has begun in the Hydrogel Endovascular Aneurysm Treatment (HEAT) clinical trial, a prospective randomised study of the use of coiling technologies to treat intracranial aneurysms.
The HydroCoil Embolic System is a unique non-bioactive endovascular embolisation device combining MicroVention’s platinum microcoil technology with a proprietary hydrogel. The hydrogel polymer is a biomaterial that begins to swell after a brief period of contact with blood, giving physicians the ability to precisely control delivery of the device.
Once the hydrogel swells, as can be shown in the above picture, it provides improved filling of the aneurysm without exerting pressure onto the aneurysm wall or adjacent coils. The HydroCoil system combines the safety of platinum coils with the filling and mechanical stability of hydrogel.
The HEAT trial will focus on the newer generations of the HydroCoil Embolic System that are designed for ease of use together with the benefits of hydrogel. The HydroCoil system offers a therapeutic alternative to the current treatment choices of platinum coils and neurosurgical clipping, and is also being used clinically to treat fistulae and peripheral vascular lesions.
This prospective, randomised, international multicenter trial is designed to compare clinical outcomes in patients treated with the new generation of the MicroVention hydrogel coils to those treated with bare platinum coils. The HEAT trial will enroll up to 600 subjects from approximately 30 sites around the world.
Bernard R. Bendok, M.D., a neurosurgeon at Northwestern Memorial Hospital, who is the principal investigator for the HEAT trial and Associate Professor at Northwestern University Hospital in Chicago, said, “Intracranial aneurysms can be a devastating, life threatening condition with approximately 30,000 people suffering from subarachnoid hemorrhage each year in the USA alone. The HEAT trial will allow us to better understand these lesions and advance their treatment.”
Richard Cappetta, President and CEO of MicroVention, Inc., said: “The HEAT trial is intended to provide evidence that our second-generation hydrogel coil technologies provide superior long-term clinical outcomes compared to bare platinum coils. In a recently published article in The Lancet reporting on our earlier HELPS trial results, MicroVention’s first-generation HydroCoil® Embolic System demonstrated superior angiographic outcomes at 18 months compared to bare platinum coils.(1) We believe that, with a comprehensive line of second-generation hydrogel technologies utilized in the HEAT trial, which includes the HydroFrame®, HydroFill® and HydroSoft® embolic coils, improvement in clinical efficacy should be even greater compared to bare platinum coils. In addition, these new gel coils are much easier to use due to their increased repositioning time, softer delivery system and standardized microcatheter delivery.”
Source: MicroVention Inc., PR Newswire