Interventional device developer MicroVention of Aliso Viejo, CA, reported that it has enrolled the 100th patient in the international trial of its HydroCoil Embolization System (HES) for treating cerebral aneurysms.
An expected total of 500 patients at more than 20 sites will ultimately make up the prospective, blinded, and randomized trial, called HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS). The head-to-head trial will compare the results derived from HES to results from any approved bare platinum coils, the company said.
The product combines MicroVention's platinum microcoil technology with a proprietary expandable microporous hydrogel called Intelligel. The Intelligel polymer is a biomaterial that does not swell until a period of contact with blood, according to the firm.
The trial is based in the U.K., where it is sponsored by the Lothian Health Board and supported by the National Health Service (NHS). Physicians in the U.S., France, and Germany are also participating, MicroVention said.
By AuntMinnie.com staff writers
August 2, 2005
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