Novel Aneurysm Treatment to Begin Clinical Trials

Food and Drug Administration (FDA) to initiate a 15-site, 138-patient clinical trial.

The treatment is Onyx LES (liquid embolic system). Using a micro catheter, the Onyx liquid embolic agent is delivered directly into the vascular malformation. Once inside, the liquid quickly transforms into a spongy polymer mass designed to exclude the malformation from blood flow and reduce the risk of rupture and subsequent stroke. Constructed of a special blend of elastomers chosen for strength and low radial pressure, Onyx is nonadhesive, controllable during deployment, and visible under fluoroscopy. The trial will mark the first direct comparison of Onyx to detachable coils.

To date, Onyx has been used worldwide in 81 brain aneurysm cases with successful acute results. A three-month follow-up has been performed in 33 cases, and only four aneurysms have required re-treatment. Onyx, which has received the CE Mark in Europe, is the product of Micro Therapeutics, Inc. (Irvine, CA, USA).

"Case results to date demonstrate Onyx to be a viable treatment option for a broad category of brain aneurysm patients, many of whom previously lacked effective therapeutic options,” said John Rush, president and CEO of Micro Therapeutics.




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