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Micro Therapeutics' Onyx OKd for Trial

March 29, 2001|Dow Jones

Micro Therapeutics Inc. said Wednesday that it has received approval from the Food and Drug Administration to begin a pivotal 15-site, 138-patient trial of the company's Onyx Liquid Embolic System for the treatment of brain aneurysms.

The Irvine medical device company said the trial will mark the first randomized, direct comparison of Onyx to detachable coils, the other existing intervention treatment for aneurysms.

They study will consist of two patient groups--one to be treated with Onyx and the other to be treated with detachable coils.

Micro Therapeutics expects full enrollment of the 138 patients to take about one year, with an additional six months needed to accumulate follow-up data.

The company anticipates filing a premarketing approval application with the FDA in the second half of 2002 and expects FDA review of the application to take one year.

Onyx has received European marketing approval.

The stock lost 6 cents, closing at $4.81 a share in Nasdaq trading.

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