GREAT Study Presented for MicroVention's HydroCoil Embolic System Coils
March 7, 2017—MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced that the multicenter German Randomized Endovascular Aneurysm Trial (GREAT) achieved its primary and secondary endpoints. GREAT Principal Investigator Prof. Christian Taschner, MD, with the University of Freiburg, Germany, presented the data on February 23 at the 2017 International Stroke Conference in Houston, Texas.
According to MicroVention, the primary endpoint of the study was met with statistical significance showing lower adverse composite outcomes in the patients treated with the company's second-generation HydroCoil embolic system coils when compared to bare platinum coils. HydroCoil features a nonbioactive, 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.
GREAT 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.
In the study, investigators treated medium-sized (4–12 mm) ruptured and unruptured intracranial aneurysms, using at least 50% hydrogel coils by length or all bare platinum coils.
Prof. Taschner noted that the GREAT trial results showed significant benefits of hydrogel technology. He commented in the company's announcement, "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."
Professor Taschner continued, "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."