MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced today that the multicenter GREAT study achieved its primary and secondary endpoints. The primary endpoint of the study was met with statistical significance showing lower adverse composite outcomes in the patients treated with 2nd generation HydroCoil® Embolic System coils when compared to bare platinum coils.
The GREAT study (German Randomized Endovascular Aneurysm Trial) was a prospective, randomized, controlled trial that enrolled 513 patients at 22 hospitals in France and Germany. 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. Investigators treated medium-sized (4-12mm) ruptured and unruptured intracranial aneurysms using at least 50% hydrogel coils by length or all bare platinum coils. Principal Investigator for the trial, Professor Christian Taschner from the University of Freiburg, Germany presented the study data at the 2017 International Stroke Conference in Houston, Texas, USA on February 23rd, 2017.
The GREAT trial results showed significant benefits of hydrogel technology, noted Professor Taschner.
“Aneurysm treatment technology is evolving quickly. It is important to understand the safety and efficacy of new devices through sound scientific methods. I was intrigued by the opportunity to test whether MicroVention’s unique hydrogel technology can improve patient outcomes in a wide-range of aneurysms,” commented Professor Taschner. “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 results of the GREAT randomized trial demonstrate the efficacy of aneurysm treatment using our hydrogel coils and are aligned with the results of other clinical studies on this technology,” added Richard E. Cappetta, President and CEO of MicroVention, Inc.
MicroVention’s 2nd generation HydroCoil Embolic System features a non-bioactive, inert hydrogel core that absorbs water from the blood and surrounding tissue, to create a stable, mechanical platform for natural tissue proliferation and long-term aneurysm occlusion. HydroFrame®, HydroFill® and HydroSoft® Embolic Coils can be used exclusively or in conjunction with traditional bare platinum coils to safely and effectively embolize a wide range of aneurysms and neurovascular lesions.