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Release: Aug. 3, 2001

UI invites people to participate in study of new endovascular surgical device

IOWA CITY, Iowa -- University of Iowa Health Care researchers led by John Chaloupka, M.D., UI associate professor of radiology and director of the Division of Interventional Neuroradiology, invite people who have an aneurysm of a brain artery to participate in a research study. This study will evaluate whether a new endovascular surgical device, known as Onyx, is a good alternative to platinum coil devices for the treatment of aneurysms within the brain.

The Onyx device is a liquid polymer (ethylene vinyl co-polymer) that upon contact with blood becomes solid and rubbery. The Onyx will be used to fill up an aneurysm and, upon becoming solid, will prevent blood from flowing into the aneurysm, therefore preventing the aneurysm from rupturing.

Currently, endovascular surgical treatment of brain aneurysms is accomplished with detachable platinum coil devices that are used to fill up the space within the aneurysm. These coil-type devices are approved by the U.S. Food and Drug Administration (FDA). However, the Onyx embolization device is currently not FDA-approved and therefore is considered investigational. The Oynx device has been used successfully in almost 90 people with aneurysms in Europe and Asia, with no complications that can be directly related to the device.

Ideal participants in this research study are those patients who have an aneurysm of a brain artery. Participation will require a commitment of a minimum of six months, which consists of the initial operation, a one-month follow-up clinic visit and CT scan, and a six-month follow-up angiogram and MRI scan.

For more information, referring physicians and interested individuals can contact Chaloupka at (319) 356-4329 or Jeri Sieren, research assistant in radiology, at (319) 356-7969.

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