MicroVention, a US subsidiary of Japan-based medical device firm Terumo, has reported a positive outcome from the GREAT trial of its 2nd generation HydroCoil embolic system coils in the treatment of patients with an aneurysm.
The HydroCoil embolic system includes a non-bioactive, inert hydrogel core that generates a stable, mechanical platform for natural tissue proliferation and long-term aneurysm occlusion, by absorbing water from the blood and surrounding tissue.
The results from the trial indicated that the embolic system has met the primary and secondary endpoints.
The prospective, randomised, controlled GREAT (German Randomised Endovascular Aneurysm Trial) trial evaluated the system in 513 patients at 22 hospitals in France and Germany.
The trial's principal investigator Professor Christian Taschner said: "I was intrigued by the opportunity to test whether MicroVention's unique hydrogel technology can improve patient outcomes in a wide-range of aneurysms.
"We are pleased that this independent study showed that hydrogel technology reduces a composite of adverse events, retreatments, morbidity and mortality compared to traditional bare platinum coils."
The primary endpoint of the trial was the statistically significant decrease in adverse composite outcomes in the patients treated with the embolic system, when compared to bare platinum coils.
The adverse event primary endpoint was a composite of major aneurysm recurrence at 18 months, retreatment at 18 months, morbidity preventing angiographic follow-up and all deaths regardless of cause.
The medium-sized (4mm to12mm) ruptured and unruptured intracranial aneurysms were treated using a minimum of 50% hydrogel coils by length or all bare platinum coils.
HydroFrame, HydroFill and HydroSoft embolic coils can be used alone or in combination with bare platinum coils to embolise various aneurysms and neurovascular lesions.